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Sample records for additional clinical studies

  1. Couples Counseling in Alzheimer’s Disease: Additional Clinical Findings from a Novel Intervention Study

    PubMed Central

    AUCLAIR, URSULA; EPSTEIN, CYNTHIA; MITTELMAN, MARY

    2009-01-01

    This article describes the clinical findings of a study designed to assess the benefit of counseling for couples, one of whom is in the early stage of Alzheimer’s disease (AD). We previously reported our findings based on the first 12 couples that enrolled in the study. Based on the treatment of 30 additional couples, we have refined our treatment strategy to include concepts of Gestalt Therapy and Transactional Analysis and identified prevalent issues of concern to this cohort. The study design has remained as described in the earlier article (Epstein et al., 2006), and has proven to be appropriate to meet the goals of this intervention as indicated by our clinical experience and feedback from the participating couples. Case vignettes demonstrate how to conduct the sessions so that the experience of each member of the dyad is validated, while acknowledging the differential impact of the disease on them. PMID:19865591

  2. Prazosin addition to fluvoxamine: A preclinical study and open clinical trial in OCD.

    PubMed

    Feenstra, Matthijs G P; Klompmakers, André; Figee, Martijn; Fluitman, Sjoerd; Vulink, Nienke; Westenberg, Herman G M; Denys, Damiaan

    2016-02-01

    The efficacy of selective serotonin reuptake inhibitors (SRIs) in psychiatric disorders may be "augmented" through the addition of atypical antipsychotic drugs. A synergistic increase in dopamine (DA) release in the prefrontal cortex has been suggested to underlie this augmentation effect, though the mechanism of action is not clear yet. We used in vivo microdialysis in rats to study DA release following the administration of combinations of fluvoxamine (10 mg/kg) and quetiapine (10 mg/kg) with various monoamine-related drugs. The results confirmed that the selective 5-HT1A antagonist WAY-100635 (0.05 mg/kg) partially blocked the fluvoxamine-quetiapine synergistic effect (maximum DA increase dropped from 325% to 214%). A novel finding is that the α1-adrenergic blocker prazosin (1 mg/kg), combined with fluvoxamine, partially mimicked the effect of augmentation (maximum DA increase 205%; area-under-the-curve 163%). As this suggested that prazosin augmentation might be tested in a clinical study, we performed an open clinical trial of prazosin 20 mg addition to SRI in therapy-resistant patients with obsessive-compulsive disorder applying for neurosurgery. A small, non-significant reduction in Yale Brown Obsessive Compulsive Scale (Y-BOCS) scores was observed in 10 patients and one patient was classified as a responder with a reduction in Y-BOCS scores of more than 25%. We suggest that future clinical studies augmenting SRIs with an α1-adrenergic blocker in less treatment resistant cases should be considered. The clinical trial "Prazosin in combination with a serotonin reuptake inhibitor for patients with Obsessive Compulsive disorder: an open label study" was registered at 24/05/2011 under trial number ISRCTN61562706: http://www.controlled-trials.com/ISRCTN61562706.

  3. A clinical comparative study of Cadiax Compact II and intraoral records using wax and addition silicone.

    PubMed

    Torabi, Kianoosh; Pour, Sasan Rasaei; Ahangari, Ahmad Hassan; Ghodsi, Safoura

    2014-01-01

    Evaluation of mandibular movements is necessary to form the occlusal anatomical contour, analyze the temporomandibular joint status, and evaluate the patient's occlusion. This clinical study was conducted to compare the mandibular recording device Cadiax Compact II with routine intraoral records for measuring condylar inclinations. The results showed that the differences between Cadiax and intraoral records were statistically significant for all measurements. Cadiax measurements had a stronger correlation with silicone records. The quantities of recorded Bennett angles were lower and the values of sagittal condylar inclination were higher with Cadiax than with routine intraoral records.

  4. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  5. Barriers and Facilitators for the Implementation of an Online Clinical Health Community in Addition to Usual Fertility Care: A Cross-Sectional Study

    PubMed Central

    Faber, Marjan J; den Boogert, Anne G; Cohlen, Ben J; van der Linden, Paul JQ; Kremer, Jan AM; Nelen, Willianne LDM

    2013-01-01

    Background Online health communities are becoming more popular in health care. Patients and professionals can communicate with one another online, patients can find peer support, and professionals can use it as an additional information channel to their patients. However, the implementation of online health communities into daily practice is challenging. These challenges relate to the fact that patients need to be activated to (1) become a member (ie, subscription) and (2) participate actively within the community before any effect can be expected. Therefore, we aimed at answering 2 research questions: (1) what factors are associated with subscription to an online health community, and (2) which are associated with becoming an active participant within an online health community. Objective To identify barriers and facilitators as perceived by patients for the implementation of an online health community. Methods We performed a cross-sectional study. Three Dutch fertility clinics (2 IVF-licensed) offered their patients a secure online clinical health community through which clinicians can provide online information and patients can ask questions to the medical team or share experiences and find support from peers. We randomly selected and invited 278 men and women suffering from infertility and attending 1 of the participating clinics. Participants filled out a questionnaire about their background characteristics and current use of the online community. Possible barriers and facilitators were divided into 2 parts: (1) those for subscription to the community, and (2) those for active participation in the community. We performed 2 multivariate logistic regression analyses to calculate determinants for both subscription and active participation. Results Subscription appeared to be associated with patients’ background characteristics (eg, gender, treatment phase), intervention-related facilitators (odds ratio [OR] 2.45, 95% CI 1.14-5.27), and patient-related barriers

  6. Additional Sawmill Electrical Energy Study.

    SciTech Connect

    Carroll, Hatch & Associates.

    1987-02-01

    This study was undertaken to investigate the potential for reducing use of electrical energy at lumber dry kilns by reducing fan speeds part way through the lumber drying process. It included three tasks: to quantify energy savings at a typical mill through field tests; to investigate the level of electric energy use at a representative sample of other mills and thereby to estimate the transferability of the conservation to the region; and to prepare a guidebook to present the technology to mill operators, and to allow them to estimate the economic value of adopting the technique at their facilities. This document reports on the first two tasks.

  7. Clinical Impact of Additional Cytogenetic Aberrations, cKIT and RAS Mutations, and Treatment Elements in Pediatric t(8;21)-AML: Results From an International Retrospective Study by the International Berlin-Frankfurt-Münster Study Group

    PubMed Central

    Klein, Kim; Kaspers, Gertjan; Harrison, Christine J.; Beverloo, H. Berna; Reedijk, Ardine; Bongers, Mathilda; Cloos, Jacqueline; Pession, Andrea; Reinhardt, Dirk; Zimmerman, Martin; Creutzig, Ursula; Dworzak, Michael; Alonzo, Todd; Johnston, Donna; Hirsch, Betsy; Zapotocky, Michal; De Moerloose, Barbara; Fynn, Alcira; Lee, Vincent; Taga, Takashi; Tawa, Akio; Auvrignon, Anne; Zeller, Bernward; Forestier, Erik; Salgado, Carmen; Balwierz, Walentyna; Popa, Alexander; Rubnitz, Jeffrey; Raimondi, Susana; Gibson, Brenda

    2015-01-01

    Purpose This retrospective cohort study aimed to determine the predictive relevance of clinical characteristics, additional cytogenetic aberrations, and cKIT and RAS mutations, as well as to evaluate whether specific treatment elements were associated with outcomes in pediatric t(8;21)-positive patients with acute myeloid leukemia (AML). Patients and Methods Karyotypes of 916 pediatric patients with t(8;21)-AML were reviewed for the presence of additional cytogenetic aberrations, and 228 samples were screened for presence of cKIT and RAS mutations. Multivariable regression models were used to assess the relevance of anthracyclines, cytarabine, and etoposide during induction and overall treatment. End points were the probability of achieving complete remission, cumulative incidence of relapse (CIR), probability of event-free survival, and probability of overall survival. Results Of 838 patients included in final analyses, 92% achieved complete remission. The 5-year overall survival, event-free survival, and CIR were 74%, 58%, and 26%, respectively. cKIT mutations and RAS mutations were not significantly associated with outcome. Patients with deletions of chromosome arm 9q [del(9q); n = 104] had a lower probability of complete remission (P = .01). Gain of chromosome 4 (+4; n = 21) was associated with inferior CIR and survival (P < .01). Anthracycline doses greater than 150 mg/m2 and etoposide doses greater than 500 mg/m2 in the first induction course and high-dose cytarabine 3 g/m2 during induction were associated with better outcomes on various end points. Cumulative doses of cytarabine greater than 30 g/m2 and etoposide greater than 1,500 mg/m2 were associated with lower CIR rates and better probability of event-free survival. Conclusion Pediatric patients with t(8;21)-AML and additional del(9q) or additional +4 might not be considered at good risk. Patients with t(8;21)-AML likely benefit from protocols that have high doses of anthracyclines, etoposide, and

  8. Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

    PubMed

    Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial.

  9. Clinical Studies with Epothilones

    NASA Astrophysics Data System (ADS)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

  10. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

  11. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice.

  12. Design, methodology, and baseline data of the Personalized Addition Lenses Clinical Trial (PACT)

    PubMed Central

    Yu, Xinping; Zhang, Binjun; Bao, Jinhua; Zhang, Junxiao; Wu, Ge; Xu, Jinling; Zheng, Jingwei; Drobe, Björn; Chen, Hao

    2017-01-01

    Abstract Background: The aim of this study was to describe the design, methods, and baseline characteristics of children enrolled in the Personalized Addition lenses Clinical Trial (PACT). PACT aims to test the myopia control efficacy of progressive addition lenses (PALs) with personalized addition values compared with standard (+2.00 D) addition PALs and single vision lenses (SVLs). Methods: PACT is a randomized, controlled, double-masked clinical trial. Two hundred eleven myopic Chinese children (7–12 years) were enrolled and randomized into 1 of the 3 following groups: personalized addition PALs; +2.00 addition PALs; and SVLs. Personalized addition values were determined based on the highest addition that satisfied Sheard criterion. Axial length and other biometric data were also recorded. Results: At baseline, no differences were found between the right and left eyes for any of the main parameters. The enrolled children were 9.7 ± 1.1 years’ old with cycloplegic autorefraction (right eye [OD]: −2.36 ± 0.64 D), near phoria (1.0 ± 5.0 prism diopter esophoria), lag of accommodation (1.40 ± 0.50 D) and axial length (OD: 24.58 ± 0.74 mm). The personalized addition values ranged from +0.75 to +3.00 (average ± SD: 2.19 ± 0.73 D). Conclusion: PACT is a clinical trial evaluating whether myopia progression in children can be slowed by wearing personalized addition PALs compared with fixed addition PALs and SVLs as measured by cycloplegic autorefraction and axial length. Baseline data were comparable with those of previous myopia control studies in children. Subjects will be followed up every 6 months for 2 years. PMID:28296722

  13. HPV vaccine cross-protection: Highlights on additional clinical benefit.

    PubMed

    De Vincenzo, Rosa; Ricci, Caterina; Conte, Carmine; Scambia, Giovanni

    2013-09-01

    Prophylactic human papillomavirus (HPV) vaccines are administered in vaccination programs, targeted at young adolescent girls before sexual exposure, and in catch-up programs for young women in some countries. All the data indicate that HPV-virus-like particles (VLPs) effectively prevent papillomavirus infections with a high level of antibodies and safety. Since non-vaccine HPV types are responsible for about 30% of cervical cancers, cross-protection would potentially enhance primary cervical cancer prevention efforts. High levels of specific neutralizing antibodies can be generated after immunization with HPV VLPs. Immunity to HPV is type-specific. However, if we consider the phylogenetic tree including the different HPV types, we realize that a certain degree of cross-protection is possible, due to the high homology of some viral types with vaccine ones. The assessment of cross-protective properties of HPV vaccines is an extremely important matter, which has also increased public health implications and could add further value to their preventive potential. The impact of cross-protection is mostly represented by a reduction of cervical intraepithelial neoplasia CIN2-3 more than what expected. In this article we review the mechanisms and the effectiveness of Bivalent (HPV-16/-18) and Quadrivalent (HPV-6/-11/-16/-18) HPV vaccine cross-protection, focusing on the critical aspects and the potential biases in clinical trials, in order to understand how cross-protection could impact on clinical outcomes and on the new perspectives in post-vaccine era.

  14. Additional branches of celiac trunk and its clinical significance.

    PubMed

    Nayak, S R; Prabhu, Latha V; Krishnamurthy, A; Ganesh Kumar, C; Ramanathan, Lakshmi A; Acharya, Abhijith; Prasad Sinha, Abhishek

    2008-01-01

    The anatomical variations of the abdominal arteries are important due to its clinical significance. Various types of vascular anomalies are frequently found in human abdominal viscera, during cadaveric dissection and diagnostic radiological imaging. The present report describes a variation in the celiac trunk as found during routine dissection in a 59-year-old male cadaver. The celiac trunk (CT) was unusually lengthy and took origin from the left antero-lateral surface of the abdominal aorta. Altogether, there were five branches, including three classic branches of CT. The left phrenic artery (LPA) was the first branch of the CT. The remaining four branches were left gastric artery (LGA), splenic artery (SA), common hepatic artery (CHA) and gastroduodenal artery (GDA). There was an arterial loop between the posterior branches of the superior pancreatico-duodenal artery (SPDA), arising from the GDA, and the posterior branch of the inferior pancreatico-duodenal artery (IPDA), arising from the superior mesenteric artery (SMA). The arterial loop formed by the above arteries, supplied the head of the pancreas and duodeno-jejunal flexure. The embryological and clinical significance of above variations has been described.

  15. Additional EIPC Study Analysis. Final Report

    SciTech Connect

    Hadley, Stanton W; Gotham, Douglas J.; Luciani, Ralph L.

    2014-12-01

    Between 2010 and 2012 the Eastern Interconnection Planning Collaborative (EIPC) conducted a major long-term resource and transmission study of the Eastern Interconnection (EI). With guidance from a Stakeholder Steering Committee (SSC) that included representatives from the Eastern Interconnection States Planning Council (EISPC) among others, the project was conducted in two phases. Phase 1 involved a long-term capacity expansion analysis that involved creation of eight major futures plus 72 sensitivities. Three scenarios were selected for more extensive transmission- focused evaluation in Phase 2. Five power flow analyses, nine production cost model runs (including six sensitivities), and three capital cost estimations were developed during this second phase. The results from Phase 1 and 2 provided a wealth of data that could be examined further to address energy-related questions. A list of 14 topics was developed for further analysis. This paper brings together the earlier interim reports of the first 13 topics plus one additional topic into a single final report.

  16. Structure Property Studies for Additively Manufactured Parts

    SciTech Connect

    Milenski, Helen M; Schmalzer, Andrew Michael; Kelly, Daniel

    2015-08-17

    Since the invention of modern Additive Manufacturing (AM) processes engineers and designers have worked hard to capitalize on the unique building capabilities that AM allows. By being able to customize the interior fill of parts it is now possible to design components with a controlled density and customized internal structure. The creation of new polymers and polymer composites allow for even greater control over the mechanical properties of AM parts. One of the key reasons to explore AM, is to bring about a new paradigm in part design, where materials can be strategically optimized in a way that conventional subtractive methods cannot achieve. The two processes investigated in my research were the Fused Deposition Modeling (FDM) process and the Direct Ink Write (DIW) process. The objectives of the research were to determine the impact of in-fill density and morphology on the mechanical properties of FDM parts, and to determine if DIW printed samples could be produced where the filament diameter was varied while the overall density remained constant.

  17. DNA binding studies of tartrazine food additive.

    PubMed

    Kashanian, Soheila; Zeidali, Sahar Heidary

    2011-07-01

    The interaction of native calf thymus DNA with tartrazine in 10 mM Tris-HCl aqueous solution at neutral pH 7.4 was investigated. Tartrazine is a nitrous derivative and may cause allergic reactions, with a potential of toxicological risk. Also, tartrazine induces oxidative stress and DNA damage. Its DNA binding properties were studied by UV-vis and circular dichroism spectra, competitive binding with Hoechst 33258, and viscosity measurements. Tartrazine molecules bind to DNA via groove mode as illustrated by hyperchromism in the UV absorption band of tartrazine, decrease in Hoechst-DNA solution fluorescence, unchanged viscosity of DNA, and conformational changes such as conversion from B-like to C-like in the circular dichroism spectra of DNA. The binding constants (K(b)) of DNA with tartrazine were calculated at different temperatures. Enthalpy and entropy changes were calculated to be +37 and +213 kJ mol(-1), respectively, according to the Van't Hoff equation, which indicated that the reaction is predominantly entropically driven. Also, tartrazine does not cleave plasmid DNA. Tartrazine interacts with calf thymus DNA via a groove interaction mode with an intrinsic binding constant of 3.75 × 10(4) M(-1).

  18. Children and Clinical Studies: Why Clinical Studies Are Important

    MedlinePlus Videos and Cool Tools

    ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a ...

  19. Learn about Clinical Studies

    MedlinePlus

    ... is to make sure that the study is ethical and that the rights and welfare of participants ... trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  20. [Clinical research III. The causality studies].

    PubMed

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  1. Study on thermal effects & sulfurized additives, in lubricating greases

    NASA Astrophysics Data System (ADS)

    Shah, Ami Atul

    Lithium Base grease constitutes about 50% of market. The greases are developed to be able to work in multiple working conditions and have longer working life. Greases with extreme pressure additives and anti-wear additives have been developed as a solution to many of the applications. These developed greases are tested under ASTM D2266 testing conditions to meet the requirements. The actual working conditions, although, differ than the real testing conditions. The loading, speed and temperature conditions can be more harsh, or fluctuating in nature. The cyclic nature of the parameters cannot be directly related to the test performance. For this purpose studies on the performance under spectrum loading, variable speed and fluctuating temperature must be performed. This study includes tests to understand the effect of thermal variation on some of the most commonly used grease additives that perform well under ASTM D2266 testing conditions. The studied additives include most widely used industrial extreme pressure additive MoS2. Performance of ZDDP which is trying to replace MoS2 in its industrial applications has also been studied. The tests cover study of extreme pressure, anti-wear and friction modifier additives to get a general idea on the effects of thermal variation in three areas. Sulphur is the most common extreme pressure additive. Sulphur based MoS 2 is extensively used grease additive. Study to understand the tribological performance of this additive through wear testing and SEM/EDX studies has been done. This performance is also studied for other metallic sulfides like WS2 and sulphur based organic compound. The aim is to study the importance of the type of bond that sulphur shares in its additive's structure on its performance. The MoS2 film formation is found to be on the basis of the FeS formation on the substrate and protection through sacrificial monolayer deposition of the MoS2 sheared structure. The free Mo then tends to oxidise. An attempt to

  2. Experimental studies: randomized clinical trials.

    PubMed

    Gjorgov, A N

    1998-01-01

    There are two major approaches to medical investigations: observational studies and experimental trials. The classical application of the experimental design to studies of human populations is the randomized clinical trial of the efficacy of a new drug or treatment. A further application of the experimental studies is to the testing of hypotheses about the etiology of a disease, already tested and corroborated from various forms of observational studies. Ethical considerations and requirements for consent of the experimental subjects are of primary concern in the clinical trials, and those concerns set the first and final limits for implementing a trial. General moral principles in research with human and animal beings, defined by the "Nuremberg Code," deal with strict criteria for approval, endorsement and evaluation of a clinical trial.

  3. An academic, clinical and industrial update on electrospun, additive manufactured and imprinted medical devices.

    PubMed

    Ryan, Christina N M; Fuller, Kieran P; Larrañaga, Aitor; Biggs, Manus; Bayon, Yves; Sarasua, Jose R; Pandit, Abhay; Zeugolis, Dimitrios I

    2015-01-01

    Electrospinning, additive manufacturing and imprint lithography scaffold fabrication technologies have attracted great attention in biomedicine, as they allow production of two- and three- dimensional constructs with tuneable topographical and geometrical features. In vitro data demonstrate that electrospun and imprinted substrates offer control over permanently differentiated and stem cell function. Advancements in functionalisation strategies have further enhanced the bioactivity and reparative capacity of electrospun and additive manufactured devices, as has been evidenced in several preclinical models. Despite this overwhelming success in academic setting, only a few technologies have reached the clinic and only a fraction of them have become commercially available products.

  4. Influence of an alloy addition on the physical and clinical behaviour of glass ionomer cement

    NASA Astrophysics Data System (ADS)

    Abour, Mohamed Abour Bashir

    These in vitro studies compared the various properties of an experimental high powder liquid content glass ionomer cement (EXPT) with those of a metal addition GIC (Hi-Dense) and disperse phase amalgam (Dispersalloy). Bi-axial, four point flexural and compressive tests were used to evaluate strength. Six groups of ten specimens were constructed for each test for each material and allowed to set in an oven at 37°C for 60 minutes. Specimens were stored in distilled water at 37°C until testing at one day, one week, one, three, six months and year. It was found that the strength of Hi-Dense increased and then maintained over extended time, whereas the strength of EXPT showed a declined at 3 months. The bond strengths of the materials to both enamel and dentine were also evaluated. Ten groups of ten teeth, five for each surface for each glass ionomer materials, were prepared. Teeth were aligned leaving the enamel and dentine surfaces exposed. The mixed material was condensed into a cylinder placed on the appropriate surface. These specimens were also stored in distilled water at 37°C. It was found that Hi-Dense had a higher bond strength to enamel that increased with time. The bond strength to dentine was maintained over the test period. The erosion rate of the materials was evaluated using the lactic acid erosion test. Three groups of six specimens for each material were constructed and tested after one hour, one day and at six months. Each specimen was subjected to an impinging jet of lactic acid solution. The erosion rate was determined by weight loss and dimensional change. It was found that Hi-Dense had a high erosion resistance which was slightly better than the experimental material. The microleakage, around restorations prepared, using the glass ionomer materials, was evaluated after cyclical loading the restoration-tooth complex. It was found that there was less leakage around Hi-Dense than EXPT at both the cervical and occlusal margins. In a clinical

  5. Mutations in RIT1 cause Noonan syndrome – additional functional evidence and expanding the clinical phenotype

    PubMed Central

    Koenighofer, Martin; Hung, Christina Y.; McCauley, Jacob L.; Dallman, Julia; Back, Emma J.; Mihalek, Ivana; Gripp, Karen W.; Sol-Church, Katia; Rusconi, Paolo; Zhang, Zhaiyi; Shi, Geng-Xian; Andres, Douglas A.; Bodamer, Olaf A.

    2015-01-01

    RASopathies are a clinically heterogeneous group of conditions caused by mutations in one of sixteen proteins in the RAS-MAPK pathway. Recently, mutations in RIT1 were identified as a novel cause for Noonan syndrome. Here we provide additional functional evidence for a causal role of RIT1 mutations and expand the associated phenotypic spectrum. We identified two de novo missense variants p.Met90Ile and, p.Ala57Gly. Both variants resulted in increased MEK-ERK signaling compared to wild-type, underscoring gain-of-function as the primary functional mechanism. Introduction of p.Met90Ile and p.Ala57Gly into zebrafish embryos reproduced not only aspects of the human phenotype but also revealed abnormalities of eye development, emphasizing the importance of RIT1 for spatial and temporal organization of the growing organism. In addition, we observed severe lymphedema of the lower extremity and genitalia in one patient. We provide additional evidence for a causal relationship between pathogenic mutations in RIT1, increased RAS-MAPK/MEK-ERK signaling and the clinical phenotype. The mutant RIT1 protein may possess reduced GTPase activity or a diminished ability to interact with cellular GTPase activating proteins, however the precise mechanism remains unknown. The phenotypic spectrum is likely to expand and includes lymphedema of the lower extremities in addition to nuchal hygroma. PMID:25959749

  6. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  7. Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction.

    PubMed

    Kerkhoffs, Jean-Louis H; van Putten, Wim L J; Novotny, Viera M J; Te Boekhorst, Peter A W; Schipperus, Martin R; Zwaginga, Jaap Jan; van Pampus, Lizzy C M; de Greef, Georgine E; Luten, Marleen; Huijgens, Peter C; Brand, Anneke; van Rhenen, Dick J

    2010-07-01

    Pathogen reduction (PR) of platelet products increases costs and available clinical studies are equivocal with respect to clinical and haemostatic effectiveness. We conducted a multicentre, open-label, randomized, non-inferiority trial comparing the clinical effectiveness of buffy-coat derived leukoreduced platelet concentrates (PC) stored for up to 7 d in plasma with platelets stored in platelet additive solution III (PASIII) without and with treatment with amotosalen-HCl/ultraviolet-A (UVA) photochemical pathogen reduction (PR-PASIII). Primary endpoint of the study was 1-h corrected count increment (CCI). Secondary endpoints were 24-h CCI, bleeding, transfusion requirement of red cells and PC, platelet transfusion interval and adverse transfusion reactions. Compared to plasma-PC, in the intention to treat analysis of 278 evaluable patients the mean difference for the 1-h CCI of PR-PASIII-PC and PASIII-PC was -31% (P < 0.0001) and -9% (P = n.s.), respectively. Twenty-seven patients (32%) had bleeding events in the PR-PASIII arm, as compared to 19 (19%) in the plasma arm and 14 (15%) in the PASIII arm (P = 0.034). Despite the potential advantages of pathogen (and leucocyte) inactivation of amotosalen-HCl/UVA-treated platelet products, their clinical efficacy is inferior to platelets stored in plasma, warranting a critical reappraisal of employing this technique for clinical use.

  8. Use of generalised additive models to categorise continuous variables in clinical prediction

    PubMed Central

    2013-01-01

    Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

  9. Benchmark Study of Industrial Needs for Additive Manufacturing in Finland

    NASA Astrophysics Data System (ADS)

    Lindqvist, Markku; Piili, Heidi; Salminen, Antti

    Additive manufacturing (AM) is a modern way to produce parts for industrial use. Even though the technical knowledge and research of AM processes are strong in Finland, there are only few industrial applications. Aim of this study is to collect practical knowledge of companies who are interested in industrial use of AM, especially in South-Eastern Finland. Goal of this study is also to investigate demands and requirements of applications for industrial use of AM in this area of Finland. It was concluded, that two of the reasons prohibiting wider industrial use of AM in Finland, are wrong expectations against this technology as well as lack of basic knowledge of possibilities of the technology. Especially, it was noticed that strong 3D-hype is even causing misunderstandings. Nevertheless, the high-level industrial know-how in the area, built around Finnish lumber industry is a strong foundation for the additive manufacturing technology.

  10. Electrostatic Levitation for Studies of Additive Manufactured Materials

    NASA Technical Reports Server (NTRS)

    SanSoucie, Michael P.; Rogers, Jan R.; Tramel, Terri

    2014-01-01

    The electrostatic levitation (ESL) laboratory at NASA's Marshall Space Flight Center is a unique facility for investigators studying high temperature materials. The laboratory boasts two levitators in which samples can be levitated, heated, melted, undercooled, and resolidified. Electrostatic levitation minimizes gravitational effects and allows materials to be studied without contact with a container or instrumentation. The lab also has a high temperature emissivity measurement system, which provides normal spectral and normal total emissivity measurements at use temperature. The ESL lab has been instrumental in many pioneering materials investigations of thermophysical properties, e.g., creep measurements, solidification, triggered nucleation, and emissivity at high temperatures. Research in the ESL lab has already led to the development of advanced high temperature materials for aerospace applications, coatings for rocket nozzles, improved medical and industrial optics, metallic glasses, ablatives for reentry vehicles, and materials with memory. Modeling of additive manufacturing materials processing is necessary for the study of their resulting materials properties. In addition, the modeling of the selective laser melting processes and its materials property predictions are also underway. Unfortunately, there is very little data for the properties of these materials, especially of the materials in the liquid state. Some method to measure thermophysical properties of additive manufacturing materials is necessary. The ESL lab is ideal for these studies. The lab can provide surface tension and viscosity of molten materials, density measurements, emissivity measurements, and even creep strength measurements. The ESL lab can also determine melting temperature, surface temperatures, and phase transition temperatures of additive manufactured materials. This presentation will provide background on the ESL lab and its capabilities, provide an approach to using the ESL

  11. Recommended Protocol for Round Robin Studies in Additive Manufacturing.

    PubMed

    Moylan, Shawn; Brown, Christopher U; Slotwinski, John

    2016-03-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST's experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed.

  12. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    PubMed Central

    Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

    2016-01-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

  13. Additional technician tasks and turnaround time in the clinical Stat laboratory

    PubMed Central

    Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Lillo, Rosa; Leiva-Salinas, Carlos

    2016-01-01

    Introduction Many additional tasks in the Stat laboratory (SL) increase the workload. It is necessary to control them because they can affect the service provided by the laboratory. Our aim is to calculate these tasks, study their evolution over a 10 year period, and compare turnaround times (TAT) in summer period to the rest of the year. Materials and methods Additional tasks were classified as “additional test request” and “additional sample”. We collected those incidences from the laboratory information system (LIS), and calculated their evolution over time. We also calculated the monthly TAT for troponin for Emergency department (ED) patients, as the difference between the verification and LIS registration time. A median time of 30 minutes was our indicator target. TAT results and tests workload in summer were compared to the rest of the year. Results Over a 10-year period, the technologists in the SL performed 51,385 additional tasks, a median of 475 per month. The workload was significantly higher during the summer (45,496 tests) than the rest of the year (44,555 tests) (P = 0.019). The troponin TAT did not show this variation between summer and the rest of the year, complying always with our 30 minutes indicator target. Conclusion The technicians accomplished a significant number of additional tasks, and the workload kept increasing over the period of 10 years. That did not affect the TAT results. PMID:27346970

  14. Genotoxicity studies of the food additive ester gum.

    PubMed

    Mukherjee, A; Agarwal, K; Chakrabarti, J

    1992-07-01

    Ester gum (EG) is used in citrus oil-based beverage flavourings as a weighting or colouring agent. In the present study, concentrations of 50, 100 and 150 mg/kg body weight were administered orally to male Swiss albino mice, and sister chromatid exchange and chromosomal aberration were used as the cytogenetic endpoints to determine the genotoxic and clastogenic potential of the food additive. Although EG was weakly clastogenic and could induce a marginal increase in sister chromatid exchange frequencies, it was not a potential health hazard at the doses tested.

  15. Making intelligent systems team players: Additional case studies

    NASA Technical Reports Server (NTRS)

    Malin, Jane T.; Schreckenghost, Debra L.; Rhoads, Ron W.

    1993-01-01

    Observations from a case study of intelligent systems are reported as part of a multi-year interdisciplinary effort to provide guidance and assistance for designers of intelligent systems and their user interfaces. A series of studies were conducted to investigate issues in designing intelligent fault management systems in aerospace applications for effective human-computer interaction. The results of the initial study are documented in two NASA technical memoranda: TM 104738 Making Intelligent Systems Team Players: Case Studies and Design Issues, Volumes 1 and 2; and TM 104751, Making Intelligent Systems Team Players: Overview for Designers. The objective of this additional study was to broaden the investigation of human-computer interaction design issues beyond the focus on monitoring and fault detection in the initial study. The results of this second study are documented which is intended as a supplement to the original design guidance documents. These results should be of interest to designers of intelligent systems for use in real-time operations, and to researchers in the areas of human-computer interaction and artificial intelligence.

  16. Additive Manufacturing Materials Study for Gaseous Radiation Detection

    SciTech Connect

    Steer, C.A.; Durose, A.; Boakes, J.

    2015-07-01

    Additive manufacturing (AM) techniques may lead to improvements in many areas of radiation detector construction; notably the rapid manufacturing time allows for a reduced time between prototype iterations. The additive nature of the technique results in a granular microstructure which may be permeable to ingress by atmospheric gases and make it unsuitable for gaseous radiation detector development. In this study we consider the application of AM to the construction of enclosures and frames for wire-based gaseous radiation tracking detectors. We have focussed on oxygen impurity ingress as a measure of the permeability of the enclosure, and the gas charging and discharging curves of several simplistic enclosure shapes are reported. A prototype wire-frame is also presented to examine structural strength and positional accuracy of an AM produced frame. We lastly discuss the implications of this study for AM based radiation detection technology as a diagnostic tool for incident response scenarios, such as the interrogation of a suspect radiation-emitting package. (authors)

  17. RAMSEYS DRAFT WILDERNESS STUDY AREA AND ADDITION, VIRGINIA.

    USGS Publications Warehouse

    Lesure, Frank G.; Mory, Peter C.

    1984-01-01

    Mineral-resource surveys of the Ramseys Draft Wilderness Study Area and adjoining roadless area addition in George Washington National Forest in the western valley and ridge province, Augusta and Highland Counties, Virginia, were done. The surveys outlined three small areas containing anomalous amounts of copper, lead, and zinc related to stratabound red-bed copper mineralization, but these occurrences are not large and are not considered as having mineral-resource potential. The area contains abundant sandstone suitable for construction materials and shale suitable for making brick, tile, and other low-grade ceramic products, but these commodities occur in abundance outside the wilderness study area. Structural conditions are probably favorable for the accumulation of natural gas, but exploratory drilling has not been done sufficiently near the area to evaluate the gas potential.

  18. [Clinical studies in developing countries].

    PubMed

    van den Munkhof, Hanna E

    2013-01-01

    In general, clinical trials in developing countries are met with resistance because the people are particularly vulnerable and medical assistance is often unaffordable. The prospect of free medication can then lead to exploitation since the local population can be persuaded to participate in trials that would never be allowed in Western countries due to ethical concerns. Placebo-controlled research that tests cheaper alternatives for treatments already registered could greatly improve the situation in developing countries, however. Expensive registered treatments are often unavailable in these countries. Therefore, I call for allowing such studies when the registered treatment is locally unavailable. This should be based on the four most important principles of medical ethics: the duty to help patients, avoid harm, justice and respect for autonomy. On the condition, however, that the population in developing countries benefits in the long term.

  19. Experimental Study of Additives on Viscosity biodiesel at Low Temperature

    NASA Astrophysics Data System (ADS)

    Fajar, Berkah; Sukarno

    2015-09-01

    An experimental investigation was performed to find out the viscosity of additive and biodiesel fuel mixture in the temperature range from 283 K to 318 K. Solutions to reduce the viscosity of biodiesel is to add the biodiesel with some additive. The viscosity was measured using a Brookfield Rheometer DV-II. The additives were the generic additive (Diethyl Ether/DDE) and the commercial additive Viscoplex 10-330 CFI. Each biodiesel blends had a concentration of the mixture: 0.0; 0.25; 0.5; 0.75; 1.0; and 1.25% vol. Temperature of biodiesel was controlled from 40°C to 0°C. The viscosity of biodiesel and additive mixture at a constant temperature can be approximated by a polynomial equation and at a constant concentration by exponential equation. The optimum mixture is at 0.75% for diethyl ether and 0.5% for viscoplex.

  20. Additive Manufacturing in Production: A Study Case Applying Technical Requirements

    NASA Astrophysics Data System (ADS)

    Ituarte, Iñigo Flores; Coatanea, Eric; Salmi, Mika; Tuomi, Jukka; Partanen, Jouni

    Additive manufacturing (AM) is expanding the manufacturing capabilities. However, quality of AM produced parts is dependent on a number of machine, geometry and process parameters. The variability of these parameters affects the manufacturing drastically and therefore standardized processes and harmonized methodologies need to be developed to characterize the technology for end use applications and enable the technology for manufacturing. This research proposes a composite methodology integrating Taguchi Design of Experiments, multi-objective optimization and statistical process control, to optimize the manufacturing process and fulfil multiple requirements imposed to an arbitrary geometry. The proposed methodology aims to characterize AM technology depending upon manufacturing process variables as well as to perform a comparative assessment of three AM technologies (Selective Laser Sintering, Laser Stereolithography and Polyjet). Results indicate that only one machine, laser-based Stereolithography, was feasible to fulfil simultaneously macro and micro level geometrical requirements but mechanical properties were not at required level. Future research will study a single AM system at the time to characterize AM machine technical capabilities and stimulate pre-normative initiatives of the technology for end use applications.

  1. The influence of different growth hormone addition protocols to poor ovarian responders on clinical outcomes in controlled ovary stimulation cycles

    PubMed Central

    Li, Xue-Li; Wang, Li; Lv, Fang; Huang, Xia-Man; Wang, Li-Ping; Pan, Yu; Zhang, Xiao-Mei

    2017-01-01

    Abstract Background: Growth hormone (GH) is used as an adjuvant therapy in in vitro fertilization and embryo transfer (IVF-ET) for poor ovarian responders, but findings for its effects on outcomes of IVF have been conflicting. The aim of the study was to compare IVF-ET outcomes among women with poor ovarian responders, and find which subgroup can benefit from the GH addition. Methods: We searched the databases, using the terms “growth hormone,” “GH,” “IVF,” “in vitro fertilization.” Randomized controlled trials (RCT) were included if they assessed pregnancy rate, live birth rate, collected oocytes, fertilization rate, and implantation rate. Extracted the data from the corresponding articles, Mantel–Haenszel random-effects model, or fixed-effects model was used. Eleven studies were included. Results: Clinical pregnancy rate (RR 1.65, 95% CI 1.23–2.22), live birth rate (RR1.73, 1.25–2.40), collected oocytes number (SMD 1.09, 95% CI 0.54–1.64), MII oocytes number (SMD 1.48, 0.84–2.13), and E2 on human chorionic gonadotropin (HCG) day (SMD 1.03, 0.18–1.89) were significantly increased in the GH group. The cancelled cycles rate (RR 0.65, 0.45–0.94) and the dose of gonadotropin (Gn) (SMD –0.83, –1.47, –0.19) were significantly lower in patients who received GH. Subgroup analysis indicated that the GH addition with Gn significantly increased the clinical pregnancy rate (RR 1.76, 1.25–2.48) and the live birth rate (RR 1.91, 1.29–2.83). Conclusion: The GH addition can significantly improve the clinical pregnancy rate and live birth rate. Furthermore, the GH addition time and collocation of medications may affect the pregnancy outcome. PMID:28328856

  2. Enhancing CBT for Chronic Insomnia: A Randomised Clinical Trial of Additive Components of Mindfulness or Cognitive Therapy.

    PubMed

    Wong, Mei Yin; Ree, Melissa J; Lee, Christopher W

    2016-09-01

    Although cognitive behavioural therapy (CBT) for insomnia has resulted in significant reductions in symptoms, most patients are not classified as good sleepers after treatment. The present study investigated whether additional sessions of cognitive therapy (CT) or mindfulness-based therapy (MBT) could enhance CBT in 64 participants with primary insomnia. All participants were given four sessions of standard CBT as previous research had identified this number of sessions as an optimal balance between therapist guidance and patient independence. Participants were then allocated to further active treatment (four sessions of CT or MBT) or a no further treatment control. The additional treatments resulted in significant improvements beyond CBT on self-report and objective measures of sleep and were well tolerated as evidenced by no dropouts from either treatment. The effect sizes for each of these additional treatments were large and clinically significant. The mean scores on the primary outcome measure, the Insomnia Severity Index, were 5.74 for CT and 6.69 for MBT, which are within the good-sleeper range. Treatment effects were maintained at follow-up. There were no significant differences between CT and MBT on any outcome measure. These results provide encouraging data on how to enhance CBT for treatment of insomnia. Copyright © 2015 John Wiley & Sons, Ltd.

  3. Drug Signature-based Finding of Additional Clinical Use of LC28-0126 for Neutrophilic Bronchial Asthma.

    PubMed

    Shin, Eunji; Lee, Yong Chul; Kim, So Ri; Kim, Soon Ha; Park, Joonghoon

    2015-12-02

    In recent decades, global pharmaceutical companies have suffered from an R&D innovation gap between the increased cost of a new drug's development and the decreased number of approvals. Drug repositioning offers another opportunity to fill the gap because the approved drugs have a known safety profile for human use, allowing for a reduction of the overall cost of drug development by eliminating rigorous safety assessment. In this study, we compared the transcriptional profile of LC28-0126, an investigational drug for acute myocardial infarction (MI) at clinical trial, obtained from healthy male subjects with molecular activity profiles in the Connectivity Map. We identified dyphilline, an FDA-approved drug for bronchial asthma, as a top ranked connection with LC28-0126. Subsequently, we demonstrated that LC28-0126 effectively ameliorates the pathophysiology of neutrophilic bronchial asthma in OVALPS-OVA mice accompanied with a reduction of inflammatory cell counts in the bronchoalveolar lavage fluid (BALF), inhibition of the release of proinflammatory cytokines, relief of airway hyperactivity, and improvement of histopathological changes in the lung. Taken together, we suggest that LC28-0126 could be a potential therapeutic for bronchial asthma. In addition, this study demonstrated the potential general utility of computational drug repositioning using clinical profiles of the investigational drug.

  4. Drug Signature-based Finding of Additional Clinical Use of LC28-0126 for Neutrophilic Bronchial Asthma

    PubMed Central

    Shin, Eunji; Lee, Yong Chul; Kim, So Ri; Kim, Soon Ha; Park, Joonghoon

    2015-01-01

    In recent decades, global pharmaceutical companies have suffered from an R&D innovation gap between the increased cost of a new drug’s development and the decreased number of approvals. Drug repositioning offers another opportunity to fill the gap because the approved drugs have a known safety profile for human use, allowing for a reduction of the overall cost of drug development by eliminating rigorous safety assessment. In this study, we compared the transcriptional profile of LC28-0126, an investigational drug for acute myocardial infarction (MI) at clinical trial, obtained from healthy male subjects with molecular activity profiles in the Connectivity Map. We identified dyphilline, an FDA-approved drug for bronchial asthma, as a top ranked connection with LC28-0126. Subsequently, we demonstrated that LC28-0126 effectively ameliorates the pathophysiology of neutrophilic bronchial asthma in OVALPS-OVA mice accompanied with a reduction of inflammatory cell counts in the bronchoalveolar lavage fluid (BALF), inhibition of the release of proinflammatory cytokines, relief of airway hyperactivity, and improvement of histopathological changes in the lung. Taken together, we suggest that LC28-0126 could be a potential therapeutic for bronchial asthma. In addition, this study demonstrated the potential general utility of computational drug repositioning using clinical profiles of the investigational drug. PMID:26626943

  5. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  6. Angular cheilitis: a clinical and microbial study.

    PubMed

    Ohman, S C; Dahlén, G; Möller, A; Ohman, A

    1986-04-01

    The purpose of this prospective study was to re-examine the relative importance of various factors in the pathogenesis of angular cheilitis. Sixty-four patients with cheilitis were examined clinically and microbiologically. In addition, a subsample of 23 patients was examined for serum iron and transferrin. The clinical appearance of the lip lesions fell into 4 categories. A ground rhagad at the corner of the mouth involving adjacent skin, was the most frequent type among dentate patients, whereas among denture wearers a deep lesion following the labial marginal sulcus was frequently observed. Dentate patients and denture wearers with cheilitis often had atopic constitution or cutaneous diseases. Pathogenic microorganisms were cultured from the lesions in all 64 patients; Staphylococcus aureus in 40 patients and Candida albicans in 45. The results of this study indicate a correlation between angular cheilitis and pathogenic microorganisms. Furthermore, among dentate patients, a correlation exists between cutaneous discomfort and angular cheilitis. Other etiological factors suggested for this disorder were found to be of subordinate importance.

  7. Hallux valgus: comparative study between two surgical techniques of proximal addition osteotomy

    PubMed Central

    Lara, Luiz Carlos Ribeiro; de Araujo, Bruno Vierno; Franco, Nelson; Hita, Roberto Minoru

    2012-01-01

    OBJECTIVE: To clinically and radiographically compare the results of treatment of hallux valgus, by two addition osteotomy techniques: one using resected exostosis, and the other using a plate fixation for addition wedge. METHODS: We evaluated 24 feet of 19 patients, mean age 51.3 years, affected by hallux valgus, with a mean follow-up of 50.1 months. 13 feet underwent addition osteotomy with resected exostosis (AORE) and 11 patients (11 feet) underwent addition osteotomy with plate (AOP). The AOFAS score, intermetatarsal 1 and 2 angles, and hallux valgus angle were evaluated before and after surgery. RESULTS: In the AORE technique, the mean preoperative AOFAS was 46.6, with IMA 14o and HVA 32o, while in the postoperative AOFAS it was 81.3, with IMA 9o and HVA 25o, and 92.3% satisfactory results. In the AOP technique, the mean preoperative AOFAS was 42.1, with IMA 15o and HVA 29o while in the postoperative AOFAS it was 77.4, with IMA 11o and HVA 23o and 81.8% of satisfactory results. CONCLUSIONS: Both techniques proved to be effective in the treatment of hallux valgus, both clinically and radiografically, with no statistical difference between them. Level of evidence III, Retrospective comparative study. PMID:24453631

  8. Additive empirical parametrization and microscopic study of deuteron breakup

    NASA Astrophysics Data System (ADS)

    Avrigeanu, M.; Avrigeanu, V.

    2017-02-01

    Comparative assessment of the total breakup proton-emission cross sections measured for 56 MeV deuteron interaction with target nuclei from 12C to 209Bi, with an empirical parametrization and recently calculated microscopic neutron-removal cross sections was done at the same time with similar data measured at 15, 25.5, 70, and 80 MeV. Comparable mass dependencies of the elastic-breakup (EB) cross sections provided by the empirical parametrization and the microscopic results have been also found at the deuteron energy of 56 MeV, while the assessment of absolute-values variance up to a factor of two was not possible because of the lack of EB measurements at energies higher than 25.5 MeV. While the similarities represent an additional validation of the microscopic calculations, the cross-section difference should be considered within the objectives of further measurements.

  9. NMR relaxometry study of plaster mortar with polymer additives

    SciTech Connect

    Jumate, E.; Manea, D.; Moldovan, D.; Fechete, R.

    2013-11-13

    The cement mixed with water forms a plastic paste or slurry which stiffness in time and finally hardens into a resistant stone. The addition of sand aggregates, polymers (Walocel) and/or calcium carbonate will modify dramatically the final mortar mechanic and thermal properties. The hydration processes can be observed using the 1D NMR measurements of transverse T{sub 2} relaxation times distributions analysed by a Laplace inversion algorithm. These distributions were obtained for mortar pasta measured at 2 hours after preparation then at 3, 7 and 28 days after preparation. Multiple components are identified in the T{sub 2} distributions. These can be associated with the proton bounded chemical or physical to the mortar minerals characterized by a short T{sub 2} relaxation time and to water protons in pores with three different pore sizes as observed from SEM images. The evaporation process is faster in the first hours after preparation, while the mortar hydration (bonding of water molecules to mortar minerals) can be still observed after days or months from preparation. Finally, the mechanic resistance was correlated with the transverse T{sub 2} relaxation rates corresponding to the bound water.

  10. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes

    PubMed Central

    Cook, Andrea J.; Wellman, Robert D.; Cherkin, Daniel C.; Kahn, Janet R.; Sherman, Karen J.

    2015-01-01

    Background Context This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of non-pharmacological treatments. Purpose To determine the optimal dose of massage for neck pain. Study Design/Setting Two-phase randomized trial for persons with chronic non-specific neck pain. Primary randomization to one of 5 groups receiving 4 weeks of massage (30 minutes 2×/ or 3×/week or 60 minutes 1×, 2×, or 3×/week). Booster randomization of participants to receive an additional 6 massages, 60 minute 1×/week, or no additional massage. Patient Sample 179 participants from Group Health and the general population of Seattle, WA USA recruited between June 2010 and August 2011. Outcome Measures Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as >5 point decrease in dysfunction and > 30% decrease in pain from baseline. Methods Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations. Secondary analyses for the continuous outcomes used linear generalized estimating equations. This study was funded the National Center for Complementary and Alternative Medicine, NIH, USA (R01 AT004411). The funders had no role in the interpretation or reporting of results. Results There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: RR=1.56(1.08–2.25), P=0.018; pain: RR=1.25(0.98–1.61); P=0.077), but those were non-significant at 26 weeks (dysfunction: RR=1.22(0.85–1.74); pain: RR=1.09(0.82–1.43)). Subgroup analysis by primary and booster treatments found the booster dose only

  11. Additional EIPC Study Analysis: Interim Report on High Priority Topics

    SciTech Connect

    Hadley, Stanton W

    2013-11-01

    Between 2010 and 2012 the Eastern Interconnection Planning Collaborative (EIPC) conducted a major long-term resource and transmission study of the Eastern Interconnection (EI). With guidance from a Stakeholder Steering Committee (SSC) that included representatives from the Eastern Interconnection States Planning Council (EISPC) among others, the project was conducted in two phases. Phase 1 involved a long-term capacity expansion analysis that involved creation of eight major futures plus 72 sensitivities. Three scenarios were selected for more extensive transmission- focused evaluation in Phase 2. Five power flow analyses, nine production cost model runs (including six sensitivities), and three capital cost estimations were developed during this second phase. The results from Phase 1 and 2 provided a wealth of data that could be examined further to address energy-related questions. A list of 13 topics was developed for further analysis; this paper discusses the first five.

  12. Additional studies for the spectrophotometric measurement of iodine in water

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Previous work in iodine spectroscopy is briefly reviewed. Continued studies of the direct spectrophotometric determination of aqueous iodine complexed with potassium iodide show that free iodine is optimally determined at the isosbestic point for these solutions. The effects on iodine determinations of turbidity and chemical substances (in trace amounts) is discussed and illustrated. At the levels tested, iodine measurements are not significantly altered by such substances. A preliminary design for an on-line, automated iodine monitor with eventual capability of operating also as a controller was analyzed and developed in detail with respect single beam colorimeter operating at two wavelengths (using a rotating filter wheel). A flow-through sample cell allows the instrument to operate continuously, except for momentary stop flow when measurements are made. The timed automatic cycling of the system may be interrupted whenever desired, for manual operation. An analog output signal permits controlling an iodine generator.

  13. Food additives and Hymenolepis nana infection: an experimental study.

    PubMed

    El-Nouby, Kholoud A; Hamouda, Hala E; Abd El Azeem, Mona A; El-Ebiary, Ahmad A

    2009-12-01

    The effect of sodium benzoate (SB) on the pathogenesis of Hymenolepis nana (H. nana) and its neurological manifestations was studied in the present work. One hundred and thirty five mice were classified into three groups. GI: received SB alone. GII: received SB before & after infection with H. nana and GIII: infected with H. nana. All groups were subjected to parasitological, histopathological, immunohistochemical and biochemical assays. The results revealed a significant decrease in IL-4 serum level with a significant increase in gamma amino butyric acid (GABA) and decrease in zinc brain levels in GI, while GII showed non significant increase in IL-4 level that resulted in a highly significant increase in the mean number of cysticercoids and adult worms with delayed expulsion as compared to GIII. This was reflected on histopathological and immunohistochemical changes in the brain. Also, there was a highly significant increase in GABA and decrease in zinc brain levels in GII to the degree that induced behavioral changes. This emphasizes the possible synergistic effect of SB on the neurological manifestations of H. nana and could, in part, explain the increased incidence of behavioral changes in children exposed to high doses of SB and unfortunately have H. nana infection.

  14. Oncolysis by paramyxoviruses: preclinical and clinical studies

    PubMed Central

    Matveeva, Olga V; Guo, Zong S; Senin, Vyacheslav M; Senina, Anna V; Shabalina, Svetlana A; Chumakov, Peter M

    2015-01-01

    Preclinical studies demonstrate that a broad spectrum of human malignant cells can be killed by oncolytic paramyxoviruses, which include cells of ecto-, endo-, and mesodermal origin. In clinical trials, significant reduction in size or even complete elimination of primary tumors and established metastases are reported. Different routes of viral administration (intratumoral, intravenous, intradermal, intraperitoneal, or intrapleural), and single- versus multiple-dose administration schemes have been explored. The reported side effects are grade 1 and 2, with the most common among them being mild fever. Some advantages in using paramyxoviruses as oncolytic agents versus representatives of other viral families exist. The cytoplasmic replication results in a lack of host genome integration and recombination, which makes paramyxoviruses safer and more attractive candidates for widely used therapeutic oncolysis in comparison with retroviruses or some DNA viruses. The list of oncolytic paramyxovirus representatives includes attenuated measles virus (MV), mumps virus (MuV), low pathogenic Newcastle disease (NDV), and Sendai (SeV) viruses. Metastatic cancer cells frequently overexpress on their surface some molecules that can serve as receptors for MV, MuV, NDV, and SeV. This promotes specific viral attachment to the malignant cell, which is frequently followed by specific viral replication. The paramyxoviruses are capable of inducing efficient syncytium-mediated lyses of cancer cells and elicit strong immunomodulatory effects that dramatically enforce anticancer immune surveillance. In general, preclinical studies and phase 1–3 clinical trials yield very encouraging results and warrant continued research of oncolytic paramyxoviruses as a particularly valuable addition to the existing panel of cancer-fighting approaches. PMID:26640815

  15. Clinical Applications of Evaluation Studies.

    ERIC Educational Resources Information Center

    Brown, Barry S.

    A series of followup investigations exploring the impact of methadone maintenance treatment, methadone detoxification treatment, therapeutic communities, and outpatient drug-free treatment for the drug abuser was conducted. Limitations of these modalities were revealed in the followup studies. Implications for treatment and policy include: (1)…

  16. Additional diverse findings expand the clinical presentation of DOCK8 deficiency.

    PubMed

    Sanal, Ozden; Jing, Huie; Ozgur, Tuba; Ayvaz, Deniz; Strauss-Albee, Dara M; Ersoy-Evans, Sibel; Tezcan, Ilhan; Turkkani, Gulten; Matthews, Helen F; Haliloglu, Goknur; Yuce, Aysel; Yalcin, Bilgehan; Gokoz, Ozay; Oguz, Kader K; Su, Helen C

    2012-08-01

    We describe seven Turkish children with DOCK8 deficiency who have not been previously reported. Three patients presented with typical features of recurrent or severe cutaneous viral infections, atopic dermatitis, and recurrent respiratory or gastrointestinal tract infections. However, four patients presented with other features. Patient 1-1 featured sclerosing cholangitis and colitis; patient 2-1, granulomatous soft tissue lesion and central nervous system involvement, with primary central nervous system lymphoma found on follow-up; patient 3-1, a fatal metastatic leiomyosarcoma; and patient 4-2 showed no other symptoms initially besides atopic dermatitis. Similar to other previously reported Turkish patients, but in contrast to patients of non-Turkish ethnicity, the patients' lymphopenia was primarily restricted to CD4(+) T cells. Patients had homozygous mutations in DOCK8 that altered splicing, introduced premature terminations, destabilized protein, or involved large deletions within the gene. Genotyping of remaining family members showed that DOCK8 deficiency is a fully penetrant, autosomal recessive disease. In our patients, bone marrow transplantation resulted in rapid improvement followed by disappearance of viral skin lesions, including lesions resembling epidermodysplasia verruciformis, atopic dermatitis, and recurrent infections. Particularly for patients who feature unusual clinical manifestations, immunological testing, in conjunction with genetic testing, can prove invaluable in diagnosing DOCK8 deficiency and providing potentially curative treatment.

  17. Statistical Issues in TBI Clinical Studies

    PubMed Central

    Rapp, Paul E.; Cellucci, Christopher J.; Keyser, David O.; Gilpin, Adele M. K.; Darmon, David M.

    2013-01-01

    The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made: (1) A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure. (2) Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy. (3) A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. (4) Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment. (5) A procedure for discriminating between treatment responders and non-responders requires, minimally, a two phase investigation. This procedure must include a mechanism to

  18. 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.

  19. Advances in clinical study of curcumin.

    PubMed

    Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

    2013-01-01

    Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

  20. Therapists' Use of DBT: A Survey Study of Clinical Practice

    ERIC Educational Resources Information Center

    DiGiorgio, Kimberly E.; Glass, Carol R.; Arnkoff, Diane B.

    2010-01-01

    The purpose of this study was to examine how therapists conduct Dialectical Behavior Therapy (DBT) individual psychotherapy with clients, focusing on clinical factors that could account for decisions regarding modifications of DBT (e.g., client diagnosis, therapist theoretical orientation, and intensity of DBT training). Additionally, the study…

  1. Tantalum trabecular metal - addition of human skeletal cells to enhance bone implant interface strength and clinical application.

    PubMed

    Smith, J O; Sengers, B G; Aarvold, A; Tayton, E R; Dunlop, D G; Oreffo, R O C

    2014-04-01

    The osteo-regenerative properties of allograft have recently been enhanced by addition of autogenous human bone marrow stromal cells (HBMSCs). Limitations in the use of allograft have prompted the investigation of tantalum trabecular metal (TTM) as a potential alternative. TTM is already in widespread orthopaedic use, although in applications where there is poor initial stability, or when TTM is used in conjunction with bone grafting, initial implant loading may need to be limited. The aim of this study was to evaluate the osteo-regenerative potential of TTM with HBMSCs, in direct comparison to human allograft and autograft. HBMSCs were cultured on blocks of TTM, allograft or autograft in basal and osteogenic media. Molecular profiling, confocal and scanning electron microscopy (SEM) and biochemical assays were used to characterize cell adherence, proliferation and phenotype. Mechanical testing was used to define the tensile characteristics of the constructs. HBMSCs displayed adherence and proliferation throughout TTM, evidenced by immunocytochemistry and SEM, with significant cellular ingrowth and matrix production through TTM. In contrast to cells cultured with allograft, cell proliferation assays showed significantly higher activity with TTM (p < 0.001), although molecular profiling confirmed no significant difference in expression of osteogenic genes. In contrast to acellular constructs, mechanical testing of cell-TTM constructs showed enhanced tensile characteristics, which compared favourably to cell-allograft constructs. These studies demonstrated the ability of TTM to support HBMSC growth and osteogenic differentiation comparable to allograft. Thus, TTM represents an alternative to allograft for osteo-regenerative strategies, extending its clinical applications as a substitute for allograft.

  2. Pseudomyogenic hemangioendothelioma: report of an additional case with aggressive clinical course.

    PubMed

    Sheng, Weiqi; Pan, Yuncui; Wang, Jian

    2013-07-01

    : Pseudomyogenic hemangioendothelioma is a recently described vascular tumor that occurs predominantly in the distal extremities of young adults. Because of multifocal presentation, epithelioid morphology, and strong cytokeratin expression, the tumor was frequently misdiagnosed as epithelioid sarcoma. However, substantial immunohistochemical studies revealed an endothelial nature. It has been currently considered a tumor of intermediate malignancy with frequent local recurrence but low risk of distant metastasis. In this report, we describe a case of pseudomyogenic hemangioendothelioma occurring in a 22-year-old man who presented with multifocal disease in the lower extremity and developed bilateral pulmonary metastases within a short period.

  3. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406

  4. Impact of microdosing clinical study -- why necessary and how useful?

    PubMed

    Sugiyama, Yuichi; Yamashita, Shinji

    2011-06-19

    The microdose (MD) clinical study enables to select a "better" compound for new drug candidate that shows desirable PK profiles in human. This new methodology is highly expected to streamline the drug development and to increase the success probability in the clinical trial. Since only a small amount of the test compound (less than 100 μg) is administered, the risk of harmful events to a human subject is regarded as minimal in the MD clinical study. However, the low dose also incurs the arguments about the usefulness of this method, since it may result in different PK profiles of drugs from that at the therapeutic dose. In addition, information on the efficacy/safety of the test compound cannot be obtained from the MD clinical study. On the other hand, PBPK model analysis based on the data of both the MD clinical study and in vitro study on metabolism, transport and binding enables the accurate prediction of PK profiles in humans at the therapeutic dose. PET molecular imaging technology further enhances the usability and applicability of the MD clinical study by offering the information on efficacy/safety. These methodologies, if coordinated effectively, are expected to innovate the new drug discovery and development.

  5. PPB | What is a Clinical Study

    Cancer.gov

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  6. Peroneal Flap: Clinical Application and Cadaveric Study

    PubMed Central

    Ha, Yooseok; Yeo, Kwan Koo; Piao, Yibo

    2017-01-01

    Background The goal of this study was to investigate the anatomy of the peroneal artery and its perforators, and to report the clinical results of reconstruction with peroneal artery perforator flaps. Methods The authors dissected 4 cadaver legs and investigated the distribution, course, origin, number, type, and length of the perforators. Peroneal artery perforator flap surgery was performed on 29 patients. Results We identified 19 perforators in 4 legs. The mean number of perforators was 4.8 per leg, and the mean length was 4.8 cm. Five perforators were found proximally, 9 medially, and 5 distally. We found 12 true septocutaneous perforators and 7 musculocutaneous perforators. Four emerged from the posterior tibia artery, and 15 were from the peroneal artery. The peroneal artery perforator flap was used in 29 patients. Retrograde island peroneal flaps were used in 8 cases, anterograde island peroneal flaps in 5 cases, and free peroneal flaps in 16 cases. The mean age was 59.9 years, and the defect size ranged from 2.0 cm×4.5 cm to 8.0 cm×8.0 cm. All the flaps survived. Five flaps developed partial skin necrosis. In 2 cases, a split-thickness skin graft was performed, and the other 3 cases were treated without any additional procedures. Conclusions The peroneal artery perforator flap is a good alternative for the reconstruction of soft tissue defects, with a constant and reliable vascular pedicle, thin and pliable skin, and the possibility of creating a composite tissue flap. PMID:28352602

  7. Clinical evidence for Japanese population based on prospective studies--linking clinical trials and clinical practice.

    PubMed

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

    "Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".

  8. Marketing and clinical trials: a case study

    PubMed Central

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-01-01

    Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

  9. Impact of contacting study authors to obtain additional data for systematic reviews: diagnostic accuracy studies for hepatic fibrosis

    PubMed Central

    2014-01-01

    Background Seventeen of 172 included studies in a recent systematic review of blood tests for hepatic fibrosis or cirrhosis reported diagnostic accuracy results discordant from 2 × 2 tables, and 60 studies reported inadequate data to construct 2 × 2 tables. This study explores the yield of contacting authors of diagnostic accuracy studies and impact on the systematic review findings. Methods Sixty-six corresponding authors were sent letters requesting additional information or clarification of data from 77 studies. Data received from the authors were synthesized with data included in the previous review, and diagnostic accuracy sensitivities, specificities, and positive and likelihood ratios were recalculated. Results Of the 66 authors, 68% were successfully contacted and 42% provided additional data for 29 out of 77 studies (38%). All authors who provided data at all did so by the third emailed request (ten authors provided data after one request). Authors of more recent studies were more likely to be located and provide data compared to authors of older studies. The effects of requests for additional data on the conclusions regarding the utility of blood tests to identify patients with clinically significant fibrosis or cirrhosis were generally small for ten out of 12 tests. Additional data resulted in reclassification (using median likelihood ratio estimates) from less useful to moderately useful or vice versa for the remaining two blood tests and enabled the calculation of an estimate for a third blood test for which previously the data had been insufficient to do so. We did not identify a clear pattern for the directional impact of additional data on estimates of diagnostic accuracy. Conclusions We successfully contacted and received results from 42% of authors who provided data for 38% of included studies. Contacting authors of studies evaluating the diagnostic accuracy of serum biomarkers for hepatic fibrosis and cirrhosis in hepatitis C patients

  10. Reversal of dental fluorosis: A clinical study

    PubMed Central

    Mehta, Dhaval N.; Shah, Jigna

    2013-01-01

    Aim: This study was conducted to evaluate the clinical reversal of dental fluorosis with various combinations of calcium, vitamin D3, and ascorbic acid, along with changes in levels of certain biochemical parameters concerned with dental fluorosis. The role of fluoride level of drinking water in the etiology of dental fluorosis and the prevalence of dental fluorosis in both dentitions and teeth were also assessed. Materials and Methods: A total number of 50 patients with clinical features of dental fluorosis without trauma and any adverse habits were selected. Of these, in 30 co-operative patients, estimation of water fluoride level and pretreatment and post-treatment serum and urine fluoride levels were done with ion selective electrode method. The selected 30 patients were divided into three groups, that is, group A, group B, and group C, and were given various combinations of medications like calcium with vitamin D3 supplements, ascorbic acid with vitamin D3 supplements, and chlorhexidine mouthwash (placebo) for three months, respectively. These 30 patients were assessed for any change in the clinical grading of dental fluorosis. Results: No change in clinical grading of dental fluorosis was noted. Considerable reduction in serum and urine fluoride levels was noted in both group A and group B patients. Dental fluorosis was noted in permanent teeth more commonly than deciduous teeth, and permanent maxillary central incisors had the highest prevalence rate. Conclusion: This study comprises only 30 patients with three months of follow-up. So, this sample of patients and duration of follow-up period are conclusive to observe changes in biochemical parameters but not sufficient to observe changes in clinical grading. PMID:23633850

  11. [The research protocol II: study designs in clinical research].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    In clinical research that takes place in health-care areas, most of the studies are performed with human beings as research subjects. The main objectives of these studies are to know the characteristics of one or more groups, the behavior of human diseases, the etiology or causes of diseases, to identify the best diagnostic tools, or to establish the best treatment for a condition or disease in particular. Additionally, some studies are classified as basic bio-medical research; in these investigations, the subjects of study are laboratory animals, tissues, cells, or molecules. In general terms, the objectives of these studies are to understand the physiology, pathogenesis, or biological mechanisms that could explain functions or alterations in one or more systems or body organs. This article will only address clinical research designs.

  12. Biosimilars entering the clinic without animal studies

    PubMed Central

    van Aerts, Leon AGJM; De Smet, Karen; Reichmann, Gabriele; van der Laan, Jan Willem; Schneider, Christian K

    2014-01-01

    The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies. PMID:25517301

  13. Study of wood plastic composite in the presence of nitrogen containing additives

    NASA Astrophysics Data System (ADS)

    Ali, K. M. Idriss; Khan, Mubarak A.; Husain, M. M.

    1994-10-01

    Effect of nitrogen-containing additives in the study of wood plastic composites of MMA with simul and mango wood of Bangladesh has been investigated. Nine different additives were used and the additives containing carboamide group induce the highest tensile strength to the composite.

  14. Aetiopathological and clinical study of erythroderma.

    PubMed

    Prakash, B V S; Sirisha, N L; Satyanarayana, V V V; Sridevi, L; Ramachandra, B V

    2009-02-01

    Erythoderma first described by Hebra in 1868 is a reaction pattern, characterised by generalised and confluent erythema with desquamation affecting more than 90% of body surface and is usually accompanied by systemic manifestation including some metabolic changes. Tile study was envisaged to assess their profile of aetiology, clinical features and to correlate with histopathological findings. Twenty-four patients (18 males and 6 females) with erythroderma were considered for the study. All patients were hospitalised, detailed history was taken and were subjected to relevant investigations--haemogram, serum proteins, liver and renal function tests, routine and microscopic urine tests, HIV screening, x-ray chest, ultrasound abdomen, FNAC of enlarged lymph nodes and skin biopsy. The age group affected ranged between 7 and 70 years, peak incidence between 50 and 60 years. The male to female ratio was 3:1. Scaling, erythema and pruritus were predominant clinical manifestations. In 12 clinically suspected psoriatic erythroderma, only in 6 cases the histopathological features were correlated to psoriasis and remaining showed non-specific chronic dermatitis. Two patients were found to be HIV-positive. There is good clinicopathological correlation in erythroderma caused by lichen planus, atopic dermatitis, seborroeic dermatitis, non-bullous congenital ichthyosiform erythroderma. Drugs were found to be aetiological factor in 3 cases. The study was conducted to assess variations in clinical, aetiological and histopathological profile of erythroderma. The present series had high percentage of erythroderma secondary to preexisting dermatoses. The onset of disease was insidious except in drug-induced erythroderma where it was acute.

  15. Addition of Rice Bran Arabinoxylan to Curcumin Therapy May Be of Benefit to Patients With Early-Stage B-Cell Lymphoid Malignancies (Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Stage 0/1 Chronic Lymphocytic Leukemia): A Preliminary Clinical Study.

    PubMed

    Golombick, Terry; Diamond, Terrence H; Manoharan, Arumugam; Ramakrishna, Rajeev

    2016-06-01

    Hypothesis Prior studies on patients with early B-cell lymphoid malignancies suggest that early intervention with curcumin may lead to delay in progressive disease and prolonged survival. These patients are characterized by increased susceptibility to infections. Rice bran arabinoxylan (Ribraxx) has been shown to have immunostimulatory, anti-inflammatory, and proapoptotic effects. We postulated that addition of Ribraxx to curcumin therapy may be of benefit. Study design Monoclonal gammopathy of undetermined significance (MGUS)/smoldering multiple myeloma (SMM) or stage 0/1 chronic lymphocytic leukemia (CLL) patients who had been on oral curcumin therapy for a period of 6 months or more were administered both curcumin (as Curcuforte) and Ribraxx. Methods Ten MGUS/SMM patients and 10 patients with stage 0/1 CLL were administered 6 g of curcumin and 2 g Ribraxx daily. Blood samples were collected at baseline and at 2-month intervals for a period of 6 months, and various markers were monitored. MGUS/SMM patients included full blood count (FBC); paraprotein; free light chains/ratio; C-reactive protein (CRP)and erythrocyte sedimentation rate (ESR); B2 microglobulin and immunological markers. Markers monitored for stage 0/1 CLL were FBC, CRP and ESR, and immunological markers. Results Of 10 MGUS/SMM patients,5 (50%) were neutropenic at baseline, and the Curcuforte/Ribraxx combination therapy showed an increased neutrophil count, varying between 10% and 90% among 8 of the 10 (80%) MGUS/SMM patients. An additional benefit of the combination therapy was the potent effect in reducing the raised ESR in 4 (44%) of the MGUS/SMM patients. Conclusion Addition of Ribraxx to curcumin therapy may be of benefit to patients with early-stage B-cell lymphoid malignancies.

  16. GAD65 autoimmunity-clinical studies.

    PubMed

    Uibo, Raivo; Lernmark, Ake

    2008-01-01

    Type 1 diabetes (T1D) in children and particularly in teenagers and adults is strongly associated with autoreactivity to the Mr 65,000 isoform of glutamic acid decarboxylase (GAD65). Autoantibodies to GAD65 are common at the time of clinical diagnosis and may be present for years prior to the onset of hyperglycemia. GAD65 autoantibodies predict conversion to insulin dependence when present in patients classified with type 2 diabetes nowadays more often referred to as patients with latent autoimmune diabetes in the adult (LADA) or type 1,5 diabetes. Analyses of T cells with HLA DRB1 0401-tetramers with GAD65-specific peptides as well as of anti-idiotypic GAD65 autoantibodies suggest that GAD65 autoreactivity is common. The immunological balance is disturbed and the appearance of GAD65 autoantibodies represents markers of autoreactive loss of pancreatic beta cells. Extensive experimental animal research, in particular of the Non-obese diabetic (NOD) mouse, showed that GAD65 therapies reduce insulitis and prevent spontaneous diabetes. Recombinant human GAD65 produced by current Good Manufacturing Practice (cGMP) and formulated with alum was found to be safe in Phase I and II placebo-controlled, double-blind, randomized clinical trials. The approach to modulate GAD65 autoreactivity with subcutaneous immunotherapy (SCIT) showed promise as alum-formulated GAD65 induced a dose-dependent reduction in the disappearance rate of endogenous residual C-peptide production. Additional controlled clinical trials are needed to uncover the mechanisms by which subcutaneous injections of recombinant human GAD65 may alter GAD65 autoreactivity.

  17. No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

    PubMed

    Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

    2016-08-01

    Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups.

  18. Clinical cardiac regenerative studies in children

    PubMed Central

    Pavo, Imre J; Michel-Behnke, Ina

    2017-01-01

    Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients. We review here the available literature data, searching the MEDLINE, Google Scholar and EMBASE database for completed, and www.clinicaltrials.gov homepage for ongoing studies involving pediatric cardiac regeneration reports. Because of difficulties conducting randomized blinded clinical trials in pediatric patients, mostly case reports or cohort studies with a limited number of individuals have been published in the field of pediatric regenerative cardiology. The majority of pediatric autologous cell transplantations into the cardiac tissue have been performed in critically ill children with severe or terminal heart failure. Congenital heart disease, myocarditis, and idiopathic hypertrophic or dilated cardiomyopathy leading to congestive heart failure are some possible areas of interest for pediatric cardiac regeneration therapy. Autologous bone marrow mononuclear cells, progenitor cells, or cardiospheres have been applied either intracoronary or percutaneously intramyocardially in severely ill children, leading to a reported clinical benefit of cell-based cardiac therapies. In conclusion, compassionate use of autologous stem cell administration has led to at least short-term improvement in heart function and clinical stability in the majority of the critically ill pediatric patients. PMID:28289528

  19. Clinical cardiac regenerative studies in children.

    PubMed

    Pavo, Imre J; Michel-Behnke, Ina

    2017-02-26

    Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients. We review here the available literature data, searching the MEDLINE, Google Scholar and EMBASE database for completed, and www.clinicaltrials.gov homepage for ongoing studies involving pediatric cardiac regeneration reports. Because of difficulties conducting randomized blinded clinical trials in pediatric patients, mostly case reports or cohort studies with a limited number of individuals have been published in the field of pediatric regenerative cardiology. The majority of pediatric autologous cell transplantations into the cardiac tissue have been performed in critically ill children with severe or terminal heart failure. Congenital heart disease, myocarditis, and idiopathic hypertrophic or dilated cardiomyopathy leading to congestive heart failure are some possible areas of interest for pediatric cardiac regeneration therapy. Autologous bone marrow mononuclear cells, progenitor cells, or cardiospheres have been applied either intracoronary or percutaneously intramyocardially in severely ill children, leading to a reported clinical benefit of cell-based cardiac therapies. In conclusion, compassionate use of autologous stem cell administration has led to at least short-term improvement in heart function and clinical stability in the majority of the critically ill pediatric patients.

  20. Addition of prednisolone and heparin in patients with failed IVF/ICSI cycles: a preliminary report of a clinical trial.

    PubMed

    Siristatidis, Charalampos; Chrelias, Charalampos; Creatsa, Maria; Varounis, Christos; Vrachnis, Nikos; Iliodromiti, Zoe; Kassanos, Demetrios

    2013-09-01

    Through a non-randomized clinical trial, we examined the theoretical benefit of the coadministration of low molecular weight heparin (LMWH) and prednisolone on pregnancy outcomes in women with previously failed IVF/ICSI cycles. Fifteen women constituted the study group, and were compared with 19 women receiving LMWH alone and another 18 women with no drugs. Our finding that the combination of the two drugs produced positive differences in terms of embryo quality, pregnancy and live birth rates points to the necessity for adequately powered randomized trials.

  1. [Depression and dementia: perspectives from clinical studies].

    PubMed

    Nozaki, Shoko; Yoshimura, Kimio; Mimura, Masaru

    2012-12-01

    In this review, we present an overview of clinical studies that addressed the relationship between depression and dementia or cognitive decline. Cross-sectional studies and meta-analyses have repeatedly shown an association between late-life depression (LLD) and dementia, particularly Alzheimer's disease (AD) and vascular dementia; however, the findings of cohort studies have been inconsistent. Furthermore, studies on the association between depression with a younger age of onset and dementia have yielded inconsistent results. Regarding cognitive decline associated with LLD, several studies have reported an association between LLD and mild cognitive impairment, suggesting that depression itself can cause persistent cognitive impairment. Other studies have compared the cognitive profile between LLD and depression with a younger age of onset, but their results have been inconclusive, especially regarding the association between memory impairment and the age of onset of depression. LLD is associated with vascular change and white matter degeneration of the brain, as shown by magnetic resonance imaging (MRI). Recently, several studies reported an association between gray matter change and LLD. Studies currently in progress employ functional brain imaging methods such as single-photon emission computed tomography, functional MRI, and positron emission tomography. Clinically, it is important to understand how subtypes of depression can be defined in terms of risk of developing dementia, and to devise effective treatments. One paper explored the possibility of detecting depression associated with AD by measuring the blood Aβ40/Aβ42 levels, and other studies have suggested that symptoms of apathy and loss of interest are associated with conversion of depression to AD. Unfortunately, current antidepressants may have limited efficacy on depression with dementia; therefore, further investigation for devising methods of predicting conversion of depression to dementia and

  2. Institutional ethics review of clinical study agreements.

    PubMed

    DuVal, G

    2004-02-01

    Clinical Study Agreements (CSAs) can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to meet adequate ethical standards. This is a failing that can have serious consequences. Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review.

  3. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children

    PubMed Central

    García-Menor, Emilia; García-Marín, Fátima; Vecino-López, Raquel; Horcajo-Martínez, Gloria; de Ibarrondo Guerrica-Echevarría, María-José; Gómez-González, Pedro; Velasco-Ortega, Syra; Suárez-Almarza, Javier; Nieto-Magro, Concepción

    2016-01-01

    This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001). The duration of diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children. PMID:28229091

  4. Evidence-based review of clinical studies on pulpotomy.

    PubMed

    2009-08-01

    Although pulpotomy procedures have a long history of clinical application, comparatively few dental clinical trials have evaluated this treatment approach. In this section, we provide an analysis of recent clinical studies evaluating pulpotomy procedures in dental patients.

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

    PubMed

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

    2015-03-01

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

  6. Food additive carrageenan: Part II: A critical review of carrageenan in vivo safety studies.

    PubMed

    Weiner, Myra L

    2014-03-01

    Carrageenan (CGN) is a seaweed-derived high molecular weight (Mw) hydrocolloid, primarily used as a stabilizer and thickener in food. The safety of CGN regarding its use in food is reviewed. Based on experimental studies in animals, ingested CGN is excreted quantitatively in the feces. Studies have shown that CGN is not significantly degraded by low gastric pH or microflora in the gastrointestinal (GI) tract. Due to its Mw, structure and its stability when bound to protein, CGN is not significantly absorbed or metabolized. CGN also does not significantly affect the absorption of nutrients. Subchronic and chronic feeding studies in rodents indicate that CGN at doses up to 5% in the diet does not induce any toxicological effects other than soft stools or diarrhea, which are a common effect for non-digestible high molecular weight compounds. Review of several studies from numerous species indicates that food grade CGN does not produce intestinal ulceration at doses up to 5% in the diet. Effects of CGN on the immune system following parenteral administration are well known, but not relevant to food additive uses. The majority of the studies evaluating the immunotoxicity potential were conducted with CGN administered in drinking water or by oral gavage where CGN exists in a random, open structured molecular conformation, particularly the lambda form; hence, it has more exposure to the intestinal mucosa than when bound to protein in food. Based on the many animal subchronic and chronic toxicity studies, CGN has not been found to affect the immune system, as judged by lack of effects on organ histopathology, clinical chemistry, hematology, normal health, and the lack of target organ toxicities. In these studies, animals consumed CGN at orders of magnitude above levels of CGN in the human diet: ≥1000 mg/kg/d in animals compared to 18-40 mg/kg/d estimated in the human diet. Dietary CGN has been shown to lack carcinogenic, tumor promoter, genotoxic, developmental, and

  7. Optimal design in pediatric pharmacokinetic and pharmacodynamic clinical studies.

    PubMed

    Roberts, Jessica K; Stockmann, Chris; Balch, Alfred; Yu, Tian; Ward, Robert M; Spigarelli, Michael G; Sherwin, Catherine M T

    2015-03-01

    It is not trivial to conduct clinical trials with pediatric participants. Ethical, logistical, and financial considerations add to the complexity of pediatric studies. Optimal design theory allows investigators the opportunity to apply mathematical optimization algorithms to define how to structure their data collection to answer focused research questions. These techniques can be used to determine an optimal sample size, optimal sample times, and the number of samples required for pharmacokinetic and pharmacodynamic studies. The aim of this review is to demonstrate how to determine optimal sample size, optimal sample times, and the number of samples required from each patient by presenting specific examples using optimal design tools. Additionally, this review aims to discuss the relative usefulness of sparse vs rich data. This review is intended to educate the clinician, as well as the basic research scientist, whom plan on conducting a pharmacokinetic/pharmacodynamic clinical trial in pediatric patients.

  8. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies.

    PubMed

    O'Donnell, Lauren A; Perry, Michael W; Doup, Dane't R

    2015-12-01

    For many students in the health sciences, including doctor of pharmacy (PharmD) students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions), and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course.

  9. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of...

  10. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 11 2011-01-01 2011-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of...

  11. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 11 2013-01-01 2013-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of...

  12. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of...

  13. 7 CFR 1710.253 - Engineering and cost studies-addition of generation capacity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 11 2012-01-01 2012-01-01 false Engineering and cost studies-addition of generation... TO ELECTRIC LOANS AND GUARANTEES Construction Work Plans and Related Studies § 1710.253 Engineering... engineering and cost studies as specified by RUS. The studies shall cover a period from the beginning of...

  14. Part-whole bias in intertemporal choice: An empirical study of additive assumption

    NASA Astrophysics Data System (ADS)

    Lu, Yang; Wu, Dongmei; Zhuang, Xintian

    2016-12-01

    Additive assumption means the overall value of multiple-dated outcomes is based on a simple aggregation of the values of each individual outcome. This assumption is generally accepted in the field of intertemporal choices. However, recent studies show additive assumption is questionable. In this paper, we experimentally tested the additive property of multiple-dated monetary rewards. Our results show: (1) additive assumption does not hold regardless of gain or loss; (2) the sum of subjective values of individual rewards is consistently larger than the valuation placed on the same rewards as a whole. This finding suggests that part-whole bias exists in the context of valuation of intertemporal monetary rewards.

  15. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  16. [Purine metabolism in ankylosing spondylitis: clinical study].

    PubMed

    Jiménez Balderas, F J; Robles, E J; Juan, L; Badui, E; Arellano, H; Espinosa Said, L; Mintz Spiro, G

    1989-01-01

    We undertook a prospective study of 23 male patients with Ankylosing Spondylitis (AS) (New York Criteria), 18 HLA-B27 positive and 5 HLA-B27 negative, five of them had hyperuricemia. The following data of evolution were taken into consideration: age at onset of disease, time course of the disease, presence of urolithiasis, heart disease, flares of uveitis. Clinical activity and degree of disability were evaluated every one to 3 months; on each visit, every patient had determinations of serum and urinary uric acid levels, serum and phosphorus, erythrocyte sedimentation rate (ESR), serum protein electrophoresis, as well as X-ray films of the vertebral spine and pelvis. Three groups of patients were detected, all of them with equal age at onset, duration of disease, frequency of B27, peripheral arthritis, and leukocytosis. One group had hyperuricemia (5 of 23 patients, 80% of them HLA-B27 positive) and a lesser degree of clinical activity of the disease (p less than .001, a higher frequency of uveitis (40%, lower levels of serum gammaglobulins (p less than 0.05) and ESR (p less than 0.05), a lesser degree of ankylosis of the spine, and a better functional prognosis than the other groups. Another group (8 of 23 patients, 75% of them were HLA-B27 positive) had normouricemia and hyperuricosuria, and showed a higher frequency of fever (50%), an abnormal urinalysis, and urolithiasis (25%).

  17. Clinical studies of intestinal folate conjugases.

    PubMed

    Halsted, C H; Beer, W H; Chandler, C J; Ross, K; Wolfe, B M; Bailey, L; Cerda, J J

    1986-03-01

    Clinical differences between the two human intestinal mucosal folate conjugases were assessed by measurement of their activities in normal individuals and in patients with chronic diarrhea of differing causes. Intracellular folate conjugase (ICFC) was 15-fold more active than brush border folate conjugase (BBFC) in jejunal mucosa from seven obese patients undergoing elective gastric bypass surgery. The activity of ICFC was similar among normal volunteers and patients with diarrhea of unknown origin (DUO), gluten-sensitive enteropathy (GSE), inflammatory bowel disease (IBD), and the short bowel syndrome (IBD-SBS). By contrast, BBFC, sucrase, and lactase were decreased significantly in GSE, and BBFC was increased in IBD-SBS. The activity of BBFC correlated with lactase and with sucrase in the normal subjects and in patients with DUO, whereas no correlations were found with the activity of ICFC in any group. Our clinical studies confirm that ICFC and BBFC are different enzymes. ICFC is not affected by intestinal disease, whereas the activity of jejunal BBFC, like that of other brush border enzymes, is decreased by mucosal injury and is also capable of adapting to distal small intestinal disease or surgical resection.

  18. Epidemiological and Clinical Studies of Nutrition

    PubMed Central

    Gibson, Todd M.; Ferrucci, Leah M.; Tangrea, Joseph A.; Schatzkin, Arthur

    2010-01-01

    In this review, we briefly summarize some of the key developments in nutritional epidemiology and cancer over the past two decades with a focus on the strengths and limitations of study designs and dietary assessment methods. We present the evidence on dietary fat, meat, fiber, antioxidant nutrients, and calcium in relation to carcinogenesis from large cohort studies and randomized clinical trials (RCTs) and refer to the conclusions of the 2007 World Cancer Research Fund/American Institute for Cancer Research summary report. One prominent theme that emerged is the lack of concordance of results from RCTs and observational studies. There are multiple potential reasons for these discrepancies, including differences in study population, dose and timing of the exposure, adherence to an intervention, length of follow-up, and the primary endpoint. Therefore, null findings of RCTs do not necessarily indicate a lack of effect for the tested dietary factors on cancer risk, as some of these nutrients may have chemopreventive effects if given at the right time and in the right dose. It is likely that potential benefits from the diet are due to a combination of food constituents rather than single components acting in isolation. Future efforts need to recognize the integrative nature of dietary exposures and attempt to study nutrients in the larger context of the foods and diets in which they are consumed. PMID:20709210

  19. Vital capacity and inspiratory capacity as additional parameters to evaluate bronchodilator response in asthmatic patients: a cross sectional study

    PubMed Central

    2012-01-01

    Background Bronchodilator response in patients with asthma is evaluated based on post-bronchodilator increase in forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). However, the need for additional parameters, mainly among patients with severe asthma, has already been demonstrated. Methods The aim of this study was to evaluate the usefulness of vital capacity (VC) and inspiratory capacity (IC) to evaluate bronchodilator response in asthma patients with persistent airflow obstruction. The 43 asthma patients enrolled in the study were stratified into moderate or severe airflow obstruction groups based on baseline FEV1. All patients performed a 6-minute walk test before and after the bronchodilator (BD). A bipolar visual analogue scale post-BD was performed to assess clinical effect. The correlation between VC and IC and clinical response, determined by visual analogue scale (VAS) and 6-minute walk test (6MWT), was investigated. Results Patients in the severe group presented: 1) greater bronchodilator response in VC (48% vs 15%, p = 0.02), 2) a significant correlation between VC variation and the reduction in air trapping (Rs = 0.70; p < 0.01), 3) a significant agreement between VC and VAS score (kappa = 0.57; p < 0.01). There was no correlation between IC and the reduction in air trapping or clinical data. Conclusions VC may be a useful additional parameter to evaluate bronchodilator response in asthma patients with severe airflow obstruction. PMID:22950529

  20. [Clinical study on mandibular bone fractures].

    PubMed

    Bahk, J S

    1989-05-01

    The purpose of this study was to investigate and to classify the patients of mandibular bone fracture who were hospitalized in the Kang-nam General Hospital. We observed clinically 57 patients from July 1983 to August 1988. The results obtained were as follows: 1. The ratio of male to female was about 6.1:1. 2. The highest age incidence was 3rd decade age group. 3. The most frequent etiologic factor was falling-down (36.8%). The next factors were fist-blow (31.6%), traffic accident (15.8%), sports (5.3%) and works (5.3%) in order. 4. The most frequent site of mandibular fractures was symphyseal area (23.1%), and mandibular angle (20.5%), condyle (19.2%), body (19.2%), alveolar bone (9.0%) and ramus (7.7%) were next in order.

  1. Managing Complex Change in Clinical Study Metadata

    PubMed Central

    Brandt, Cynthia A.; Gadagkar, Rohit; Rodriguez, Cesar; Nadkarni, Prakash M.

    2004-01-01

    In highly functional metadata-driven software, the interrelationships within the metadata become complex, and maintenance becomes challenging. We describe an approach to metadata management that uses a knowledge-base subschema to store centralized information about metadata dependencies and use cases involving specific types of metadata modification. Our system borrows ideas from production-rule systems in that some of this information is a high-level specification that is interpreted and executed dynamically by a middleware engine. Our approach is implemented in TrialDB, a generic clinical study data management system. We review approaches that have been used for metadata management in other contexts and describe the features, capabilities, and limitations of our system. PMID:15187070

  2. A Clinical Study of 35 Cases of Pincer Nails

    PubMed Central

    Lee, Jae In; Lee, Young Bok; Oh, Shin Tack; Cho, Baik Kee

    2011-01-01

    Background Pincer nail is a nail deformity characterized by transverse overcurvature of the nail plate. Pincer nail can affect a patient's quality of life due to its chronic, recurrent course; however, there have been no clinical studies on the pincer nail condition in Korean patients. Objective The purpose of this study was to characterize the clinical findings and treatment of pincer nail. In addition, possible etiological factors were considered, and treatment efficacy was evaluated. Methods The medical records and clinical photographs of 35 patients (12 males, 23 females) who were diagnosed with pincer nail between August 1, 2005 and July 31, 2009 were studied. Results Patient age ranged from 10 to 77 (52.09±17.26) years, and there was a predominance of female (23 out of 35 patients, F:M=2:1). The mean duration of the disorder was 7.45 years (range 0.25~40); 85% had pincer nail for at least 1 year. In addition, 40% had a history of previous treatment and recurrence. There were 82.8% patients with the common type of pincer nails. The most commonly involved nails were both great toenails. Among 35 patients, nail grinding was started in 30 patients, and 25 patients showed clinical improvement with nail grinding. The width index increased and the height index decreased after treatment. The mean follow up period was 8.42 months (range 1~27), and 7 patients showed recurrence after 8.8 months (range 2~20). Among 35 patients, 5 patients were treated with nail extraction with matricectomy, and the symptoms resolved immediately. The mean follow up period was 7.6 months (range 0~19), and recurrence was not observed. Onychomycosis was also present in 37.1% of patients, and itraconazole pulse therapy for 3 months was added. Conclusion The results of this study demonstrate the clinical features of pincer nail in Korean patients. The findings show that the common type of pincer nail was most common, and nail grinding as a conservative treatment greatly improved pincer nails

  3. Clinical Evaluation of Functional Vision of +1.5 Diopters near Addition, Aspheric, Rotational Asymmetric Multifocal Intraocular Lens

    PubMed Central

    Khoramnia, Rahmin; Attia, Mary Safwat; Koss, Michael Janusz; Linz, Katharina; Auffarth, Gerd Uwe

    2016-01-01

    Purpose To evaluate postoperative outcomes and visual performance in intermediate distance after implantation of a +1.5 diopters (D) addition, aspheric, rotational asymmetric multifocal intraocular lens (MIOL). Methods Patients underwent bilateral cataract surgery with implantation of an aspheric, asymmetric MIOL with +1.5 D near addition. A complete ophthalmological examination was performed preoperatively and 3 months postoperatively. The main outcome measures were monocular and binocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UNVA) and distance corrected keratometry, and manifest refraction. The Salzburg Reading Desk was used to analyze unilateral and bilateral functional vision with uncorrected and corrected reading acuity, reading distance, reading speed, and the smallest log-scaled print size that could be read effectively at near and intermediate distances. Results The study comprised 60 eyes of 30 patients (mean age, 68.30 ± 9.26 years; range, 34 to 80 years). There was significant improvement in UDVA and CDVA. Mean UIVA was 0.01 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and mean DCIVA was -0.02 ± 0.11 logMAR. In Salzburg Reading Desk analysis for UIVA, the mean subjective intermediate distance was 67.58 ± 8.59 cm with mean UIVA of -0.02 ± 0.09 logMAR and mean word count of 96.38 ± 28.32 words/min. Conclusions The new aspheric, asymmetric, +1.5 D near addition MIOL offers good results for distance visual function in combination with good performance for intermediate distances and functional results for near distance. PMID:27729759

  4. Erythroderma: A clinical study of 97 cases

    PubMed Central

    Akhyani, Maryam; Ghodsi, Zahra S; Toosi, Siavash; Dabbaghian, Hossein

    2005-01-01

    Background Erythroderma is a rare skin disorder that may be caused by a variety of underlying dermatoses, infections, systemic diseases and drugs. Methods We reviewed the clinical, laboratory and biopsy material of 97 patients diagnosed with erythroderma who were treated in our department over a 6-year period (1996 through 2002). Results The male-female ratio was 1.85:1. The mean age at diagnosis was 46.2 years. The most common causative factors were dermatoses (59.7%), followed by drug reactions (21.6%), malignancies (11.3%) and idiopathic causes (7.2%). Carbamazepine was the most common drug (57.1%). The best clinicopathologic correlation was found in cutaneous T-cell lymphoma and pityriasis rubra pilaris related erythroderma. Apart from scaling and erythema that were present in all patients, pruritus was the most common finding (97.5%), followed by fever (33.6%), lymphadenopathy (21.3%), edema (14.4%) and hyperkeratosis (7.2%). Conclusion This study outlines that underlying etiologic factors of erythroderma may show geographic variations. Our series had a high percentage of erythroderma secondary to preexisting dermatoses and a low percentage of idiopathic cases. There was no HIV-infected patient among our series based on multiple serum antibody tests. The clinical features of erythroderma were identical, irrespective of the etiology. The onset of the disease was usually insidious except in drug-induced erythroderma, where it was acute. The group associated with the best prognosis was that related to drugs. PMID:15882451

  5. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    PubMed Central

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  6. Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study.

    PubMed

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-11-13

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.

  7. Evaluating Drugs and Food Additives for Public Use: A Case Studies Approach.

    ERIC Educational Resources Information Center

    Merritt, Sheridan V.

    1980-01-01

    Described is a case study used in an introductory college biology course that provides a basis for generating debate on an issue concerning the regulation of controversial food additives and prescription drugs. The case study contained within this article deals with drug screening, specifically with information related to thalidomide. (CS)

  8. Updates on clinical studies of selenium supplementation in radiotherapy

    PubMed Central

    2014-01-01

    To establish guidelines for the selenium supplementation in radiotherapy we assessed the benefits and risks of selenium supplementation in radiotherapy. Clinical studies on the use of selenium in radiotherapy were searched in the PubMed electronic database in January 2013. Sixteen clinical studies were identified among the 167 articles selected in the initial search. Ten articles were observational studies, and the other 6 articles reported studies on the effects of selenium supplementation in patients with cancer who underwent radiotherapy. The studies were conducted worldwide including European, American and Asian countries between 1987 and 2012. Plasma, serum or whole blood selenium levels were common parameters used to assess the effects of radiotherapy and the selenium supplementation status. Selenium supplementation improved the general conditions of the patients, improved their quality of life and reduced the side effects of radiotherapy. At the dose of selenium used in these studies (200–500 μg/day), selenium supplementation did not reduce the effectiveness of radiotherapy, and no toxicities were reported. Selenium supplementation may offer specific benefits for several types of cancer patients who undergo radiotherapy. Because high-dose selenium and long-term supplementation may be unsafe due to selenium toxicity, more evidence-based information and additional research are needed to ensure the therapeutic benefits of selenium supplementation. PMID:24885670

  9. Patient advocacy from the clinical nurses' viewpoint: a qualitative study

    PubMed Central

    Davoodvand, Shirmohammad; Abbaszadeh, Abbas; Ahmadi, Fazlollah

    2016-01-01

    One of the advanced nursing care procedures emphasized by nursing organizations around the world is patient or nursing advocacy. In addition to illustrating the professional power of nursing, it helps to provide effective nursing care. The aim of the present study was to explain the concept of patient advocacy from the perspective of Iranian clinical nurses. This was a qualitative study that examined the viewpoint and experiences of 15 clinical nurses regarding patient advocacy in nursing. The nurses worked in intensive care units (ICUs), coronary care units (CCUs), and emergency units. The study participants were selected via purposeful sampling. The data was collected through semi-structured interviews and analyzed using content analysis. Data analysis showed that patient advocacy consisted of the two themes of empathy with the patient (including understanding, being sympathetic with, and feeling close to the patient) and protecting the patients (including patient care, prioritization of patients’ health, commitment to the completion of the care process, and protection of patients' rights). The results of this study suggest that nurses must be empathetic toward and protective of their patients. The results of the present study can be used in health care delivery, nursing education, and nursing management and planning systems to help nurses accomplish their important role as patient advocates. It is necessary to further study the connections between patient advocacy and empathy. PMID:27471588

  10. Updates on clinical studies of selenium supplementation in radiotherapy.

    PubMed

    Puspitasari, Irma M; Abdulah, Rizky; Yamazaki, Chiho; Kameo, Satomi; Nakano, Takashi; Koyama, Hiroshi

    2014-05-29

    To establish guidelines for the selenium supplementation in radiotherapy we assessed the benefits and risks of selenium supplementation in radiotherapy. Clinical studies on the use of selenium in radiotherapy were searched in the PubMed electronic database in January 2013. Sixteen clinical studies were identified among the 167 articles selected in the initial search. Ten articles were observational studies, and the other 6 articles reported studies on the effects of selenium supplementation in patients with cancer who underwent radiotherapy. The studies were conducted worldwide including European, American and Asian countries between 1987 and 2012. Plasma, serum or whole blood selenium levels were common parameters used to assess the effects of radiotherapy and the selenium supplementation status. Selenium supplementation improved the general conditions of the patients, improved their quality of life and reduced the side effects of radiotherapy. At the dose of selenium used in these studies (200-500 μg/day), selenium supplementation did not reduce the effectiveness of radiotherapy, and no toxicities were reported. Selenium supplementation may offer specific benefits for several types of cancer patients who undergo radiotherapy. Because high-dose selenium and long-term supplementation may be unsafe due to selenium toxicity, more evidence-based information and additional research are needed to ensure the therapeutic benefits of selenium supplementation.

  11. Patient advocacy from the clinical nurses' viewpoint: a qualitative study.

    PubMed

    Davoodvand, Shirmohammad; Abbaszadeh, Abbas; Ahmadi, Fazlollah

    2016-01-01

    One of the advanced nursing care procedures emphasized by nursing organizations around the world is patient or nursing advocacy. In addition to illustrating the professional power of nursing, it helps to provide effective nursing care. The aim of the present study was to explain the concept of patient advocacy from the perspective of Iranian clinical nurses. This was a qualitative study that examined the viewpoint and experiences of 15 clinical nurses regarding patient advocacy in nursing. The nurses worked in intensive care units (ICUs), coronary care units (CCUs), and emergency units. The study participants were selected via purposeful sampling. The data was collected through semi-structured interviews and analyzed using content analysis. Data analysis showed that patient advocacy consisted of the two themes of empathy with the patient (including understanding, being sympathetic with, and feeling close to the patient) and protecting the patients (including patient care, prioritization of patients' health, commitment to the completion of the care process, and protection of patients' rights). The results of this study suggest that nurses must be empathetic toward and protective of their patients. The results of the present study can be used in health care delivery, nursing education, and nursing management and planning systems to help nurses accomplish their important role as patient advocates. It is necessary to further study the connections between patient advocacy and empathy.

  12. Clinical committee report: Recommendation for further clinical trials-patient studies

    SciTech Connect

    Ellis, F.

    1986-01-01

    The Cf-252 (Cf) neutron brachytherapy (NT) trials should continue to explore the feasibility of Cf-NT treatment of a variety of bulky human cancers. Results hitherto from the USA (Lexington), Japan, USSR, and England justify trials on a research basis. The term ''bulky'' is imprecise and in future studies should be specified by measurement. U.S. Department of Energy and other suppliers need to be advised to fabricate Cf-252 sources in more appropriate sizes, strengths and configurations for clinical therapy. Study of facility design and development should continue with special attention to: 1) treatment centers, 2) afterloading devices, 3) automated/robotics and other specialized equipment for handling Cf-252, 4) shields and shielding material, 5) controlled duration treatments, 6) necessary specialized equipment for conducting Cf-NT trials and 7) safety for personnel. In addition to the aforementioned, the report makes recommendations in several other areas such as doses and schedules, randomized trials, and records.

  13. Hormones, nicotine, and cocaine: clinical studies.

    PubMed

    Mello, Nancy K

    2010-06-01

    Nicotine and cocaine each stimulate hypothalamic-pituitary-adrenal and -gonadal axis hormones, and there is increasing evidence that the hormonal milieu may modulate the abuse-related effects of these drugs. This review summarizes some clinical studies of the acute effects of cigarette smoking or IV cocaine on plasma drug and hormone levels and subjective effects ratings. The temporal covariance between these dependent measures was assessed with a rapid (2 min) sampling procedure in nicotine-dependent volunteers or current cocaine users. Cigarette smoking and IV cocaine each stimulated a rapid increase in LH and ACTH, followed by gradual increases in cortisol and DHEA. Positive subjective effects ratings increased immediately after initiation of cigarette smoking or IV cocaine administration. However, in contrast to cocaine's sustained positive effects (<20 min), ratings of "high" and "rush" began to decrease within one or two puffs of a high-nicotine cigarette while nicotine levels were increasing. Peak nicotine levels increased progressively after each of three successive cigarettes smoked at 60 min intervals, but the magnitude of the subjective effects ratings and peak ACTH and cortisol levels diminished. Only DHEA increased consistently after successive cigarettes. The possible influence of neuroactive hormones on nicotine dependence and cocaine abuse and the implications for treatment of these addictive disorders are discussed.

  14. Hormones, Nicotine and Cocaine: Clinical Studies

    PubMed Central

    Mello, Nancy K.

    2009-01-01

    Nicotine and cocaine each stimulate hypothalamic-pituitary-adrenal and -gonadal axis hormones, and there is increasing evidence that the hormonal milieu may modulate the abuse-related effects of these drugs. This review summarizes some clinical studies of the acute effects of cigarette smoking or IV cocaine on plasma drug and hormone levels, and subjective effects ratings. The temporal covariance between these dependent measures was assessed with a rapid (two min) sampling procedure in nicotine-dependent volunteers or current cocaine users. Cigarette smoking and IV cocaine each stimulated a rapid increase in LH and ACTH, followed by gradual increases in cortisol and DHEA. Positive subjective effects ratings increased immediately after initiation of cigarette smoking or IV cocaine administration. However, in contrast to cocaine’s sustained positive effects (< 20 min), ratings of “High” and “Rush” began to decrease within one or two puffs of a high nicotine cigarette while nicotine levels were increasing. Peak nicotine levels increased progressively after each of three successive cigarettes smoked at 60 min intervals, but the magnitude of the subjective effects ratings and peak ACTH and cortisol levels diminished. Only DHEA increased consistently after successive cigarettes. The possible influence of neuroactive hormones on nicotine dependence and cocaine abuse, and implications for treatment of these addictive disorders is discussed. PMID:19835877

  15. [TG-FTIR study on pyrolysis of wheat-straw with abundant CaO additives].

    PubMed

    Han, Long; Wang, Qin-Hui; Yang, Yu-Kun; Yu, Chun-Jiang; Fang, Meng-Xiang; Luo, Zhong-Yang

    2011-04-01

    Biomass pyrolysis in presence of abundant CaO additives is a fundamental process prior to CaO sorption enhanced gasification in biomass-based zero emission system. In the present study, thermogravimetric Fourier transform infrared (TG-FTIR) analysis was adopted to examine the effects of CaO additives on the mass loss process and volatiles evolution of wheat-straw pyrolysis. Observations from TG and FTIR analyses simultaneously demonstrated a two-stage process for CaO catalyzed wheat-straw pyrolysis, different from the single stage process for pure wheat-straw pyrolysis. CaO additives could not only absorb the released CO2 but also reduce the yields of tar species such as toluene, phenol, and formic acid in the first stage, resulting in decreased mass loss and maximum mass loss rate in this stage with an increase in CaO addition. The second stage was attributed to the CaCO3 decomposition and the mass loss and maximum mass loss rate increased with increasing amount of CaO additives. The results of the present study demonstrated the great potential of CaO additives to capture CO2 and reduce tars yields in biomass-based zero emission system. The gasification temperature in the system should be lowered down to avoid CaCO3 decomposition.

  16. Study raises questions about measurement of 'additionality,'or maintaining domestic health spending amid foreign donations.

    PubMed

    Garg, Charu C; Evans, David B; Dmytraczenko, Tania; Izazola-Licea, José-Antonio; Tangcharoensathien, Viroj; Ejeder, Tessa Tan-Torres

    2012-02-01

    Donor nations and philanthropic organizations increasingly require that funds provided for a specific health priority such as HIV should supplement domestic spending on that priority-a concept known as "additionality." We investigated the "additionality" concept using data from Honduras, Rwanda, and Thailand, and we found that the three countries increased funding for HIV in response to increased donor funding. In contrast, the study revealed that donors, faced with increased Global Fund resources for HIV in certain countries, tended to decrease their funding for HIV or shift funds for use in non-HIV health areas. More broadly, we found many problems in the measurement and interpretation of additionality. These findings suggest that it would be preferable for donors and countries to agree on how best to use available domestic and external funds to improve population health, and to develop better means of tracking outcomes, than to try to develop more sophisticated methods to track additionality.

  17. Eurythmy Therapy in clinical studies: a systematic literature review

    PubMed Central

    Büssing, Arndt; Ostermann, Thomas; Majorek, Magdalena; Matthiessen, Peter F

    2008-01-01

    Background We aimed to overview the current literature on eurythmy therapy (EYT) which is an integral part of Anthroposophic Medicine. EYT can be described as a movement therapy in which speech movements are transposed into exercises which address the patient's capability to soul expression and strengthen his salutogenetic resources. Methods We searched several databases such as Cochrane, EMBASE, NCCAM, NLM, DIMDI, CAMbase, and Medline for case-control studies, cohort studies and randomised controlled trials on the treatment effects of EYT in a clinical setting. In a second search we included journal databases from Karger, Kluwer, Springer, Thieme, and Merkurstab archive. Results We found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study), and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases. Conclusion Indications, study designs and the usage of additional treatments within the identified studies were quite heterogeneous. Despite of this, EYT can be regarded as a potentially relevant add-on in a therapeutic concept, although its specific relevance remains to be clarified. Well performed controlled studies on this unique treatment are highly recommended. PMID:18377647

  18. Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

    ERIC Educational Resources Information Center

    Chester, Victoria

    2011-01-01

    Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

  19. [Bootstrap method-based estimation on the confidence interval for additive interaction in cohort studies].

    PubMed

    Pan, Jin-ren; Chen, Kun

    2010-07-01

    Interaction assessment is an important step in epidemiological analysis. When etiological study is carried out, the logarithmic models such as logistic model or Cox proportional hazard model are commonly used to estimate the independent effects of the risk factors. However, estimating interaction between risk factors by the regression coefficient of the product term is on multiplicative scale, and for public-health purposes, it is supposed to be on additive scale or departure from additivity. This paper illustrates with a example of cohort study by fitting Cox proportional hazard model to estimate three measures for additive interaction which presented by Rothman. Adopting the S-Plus application with a built-in Bootstrap function, it is convenient to estimate the confidence interval for additive interaction. Furthermore, this method can avoid the exaggerated estimation by using ORs in a cohort study to gain better precision. When using the complex combination models between additive interaction and multiplicative interaction, it is reasonable to choose the former one when the result is inconsistent.

  20. Comparative study of electrolyte additives using electrochemical impedance spectroscopy on symmetric cells

    NASA Astrophysics Data System (ADS)

    Petibon, R.; Sinha, N. N.; Burns, J. C.; Aiken, C. P.; Ye, Hui; VanElzen, Collette M.; Jain, Gaurav; Trussler, S.; Dahn, J. R.

    2014-04-01

    The effect of various electrolyte additives and additive combinations added to a 1 M LiPF6 EC:EMC electrolyte on the positive and negative electrodes surface of 1 year old wound LiCoO2/graphite cells and Li[Ni0.4Mn0.4Co0.2])O2/graphite cells was studied using electrochemical impedance spectroscopy (EIS) on symmetric cells. The additives tested were: vinylene carbonate (VC), trimethoxyboroxine (TMOBX), fluoroethylene carbonate (FEC), lithium bis(trifluoromethanesulfonyl)imide (LiTFSI), and H2O alone or in combination. In general, compared to control electrolyte, the additives tested reduced the impedance of the positive electrode and increased the impedance of the negative electrode with the exception of LiTFSI in Li[Ni0.4Mn0.4Co0.2]O2/graphite wound cells. Higher charge voltage led to higher positive electrode impedance, with the exception of 2%VC + 2% FEC, and 2% LiTFSI. In some cases, some additives when mixed with another controlled the formation of the SEI at one electrode, and shared the formation of the SEI at one electrode when mixed with a different additive.

  1. A Clinical Study of Electrical Accidents

    PubMed Central

    Lee, W. R.

    1961-01-01

    The report of a clinical study of 104 electrical accidents which befell 85 men is divided into two parts. Part I enumerates the different types of accidents as flash burn, Joule burn, arc eye, “held on” shock and “not held” shock, physical shock, and death. These are related to the different voltages involved ranging from 240/415 (medium) voltage to 33 kilovolts. There appeared to be no association between voltage and type of injury and no evidence to suggest that any of the voltages are free from hazard. There were 53 cases of flash burn, affecting mostly the face and extensor surface of the hands and arms. The 16 cases of arc eye caused no serious concern. Of the 15 Joule burns all except one occurred at medium voltages in “held on” accidents, the other being associated with an electric shock at 33 kilovolts. The majority of Joule burns affected the flexor surfaces. Part II of the paper deals with the 43 cases of electric shock (passage of current through the body). Thirty of these cases were “held on” to the circuit by the current. It was found that the longer a victim was held on to the circuit the greater appeared to be his chances of developing heart and chest symptoms suggestive of impending asphyxia, and of losing consciousness. Although about half of these men were released by an external agency and others struggled off, a number suddenly became free from the circuit without, they claimed, losing consciousness. This is difficult to explain. Artificial respiration was administered in two cases, one of whom was “held on” and was being asphyxiated. The other case received flash burns only and did not in fact receive an electric shock. PMID:14463581

  2. Generating Scenarios of Addition and Subtraction: A Study of Japanese University Students

    ERIC Educational Resources Information Center

    Kinda, Shigehiro

    2013-01-01

    Students are presented with problems involving three scenario types of addition and subtraction in elementary mathematics: one dynamic ("Change") and two static ("Combine, Compare"). Previous studies have indicated that the dynamic type is easier for school children, whereas the static types are more difficult and comprehended only gradually…

  3. Performance on Addition and Subtraction Problems: Results from Individual Interviews - Sandy Bay Study.

    ERIC Educational Resources Information Center

    Romberg, Thomas A.; And Others

    The purpose of this study was to relate children's cognitive processing capabilities and their grade level to their performance and to the strategies they used when working addition and subtraction problems. From two sets of data which assessed memory capacity and cognitive processing capacities, six groups of children with different cognitive…

  4. Using E-Learning to Enhance the Learning of Additional Languages--A Pilot Comparative Study

    ERIC Educational Resources Information Center

    Hilton, Gillian L. S.

    2013-01-01

    This paper is concerned with a small pilot study to ascertain the use of, and changes in the use of e-learning to promote the learning of foreign and additional languages in a variety of countries in Europe. It was undertaken by individual researchers in an attempt to examine how the drive towards the teaching of new languages, encouraged by the…

  5. Industry research on the use and effects of levulinic acid: a case study in cigarette additives.

    PubMed

    Keithly, Lois; Ferris Wayne, Geoffrey; Cullen, Doris M; Connolly, Gregory N

    2005-10-01

    Public health officials and tobacco researchers have raised concerns about the possible contributions of additives to the toxicity of cigarettes. However, little attention has been given to the process whereby additives promote initiation and addiction. Levulinic acid is a known cigarette additive. Review of internal tobacco industry documents indicates that levulinic acid was used to increase nicotine yields while enhancing perceptions of smoothness and mildness. Levulinic acid reduces the pH of cigarette smoke and desensitizes the upper respiratory tract, increasing the potential for cigarette smoke to be inhaled deeper into the lungs. Levulinic acid also may enhance the binding of nicotine to neurons that ordinarily would be unresponsive to nicotine. These findings held particular interest in the internal development of ultralight and so-called reduced-exposure cigarette prototypes. Industry studies found significantly increased peak plasma nicotine levels in smokers of ultralight cigarettes following addition of levulinic acid. Further, internal studies observed changes in mainstream and sidestream smoke composition that may present increased health risks. The use of levulinic acid illustrates the need for regulatory authority over tobacco products as well as better understanding of the role of additives in cigarettes and other tobacco products.

  6. [Changing surgical therapy because of clinical studies?].

    PubMed

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

    The randomised controlled clinical trial (RCT) is a powerful instrument to evaluate different therapeutic regimens. In a survey among 115 physicians visiting the 25th annual meeting of the Surgical Society of Berlin and Brandenburg, the RCT was judged to be very important when changes of therapeutic strategies are discussed. 90 % of all participants claimed to use data from RCTs in the clinical routine and 89 % would participate in such a trial. In official (e. g. discussions during coffee breaks at scientific meetings) or non-medical (e. g. non-scientific press or media) sources of information were assessed as irrelevant for decisions regarding therapeutic strategies. However, in contrast to this view laparoscopic cholecystectomy was introduced into clinical practice rapidly because patients informed by external (non-medical) sources preferred to be operated on with the "modern" technique. Clinical trials with a high level of evidence had no relevant influence on the rapid distribution of laparoscopic cholecystectomy. Controversial discussions concerning the extent of lymphadenectomy with gastric resection for carcinoma demonstrate that the value of excellent clinical RCTs is low if their results challenge a stable paradigma of the surgical scientific society. To allow a rational judgement, new surgical technologies should undergo a scientific gradual evaluation in agreement with the principles of evidence based medicine.

  7. [Clinical studies of pediatric malabsorption syndromes].

    PubMed

    Hosoyamada, Takashi

    2006-11-01

    Multiple cases with various types of pediatric malabsorption syndromes were evaluated. The clinical manifestations, laboratory findings, pathophysiology, and histopathological descriptions of each patient were analyzed in an effort to clear the pathogenesis of the malabsorption syndromes and the treatments were undertaken. The cases studied, included one patient with cystic fibrosis, two with lactose intolerance with lactosuria (Durand type), one with primary intestinal lymphangiectasia, two with familial hypobetalipoproteinemia, one with Hartnup disease, one with congenital chroride diarrhea, one with acrodermatitis enteropathica, one with intestinal nodular lymphoid hyperplasia (NLH), five with intractable diarrhea of early infancy and four with glycogenosis type Ia. Each case description and outcome is described below: 1. A 15-year-old Japanese boy with cystic fibrosis presented with severe symptoms, including pancreatic insufficiency, bronchiectasis, pneumothorax and hemoptysis. His prognosis was poor. Analysis of the CFTR genes of this patient revealed a homozygous large deletion from intron 16 to 17b. 2. In the sibling case of Durand type lactose intolerance, the subjects'disaccaridase activity of the small bowel, including lactase, were within normal limits. The results of per oral and per intraduodenal lactose tolerance tests confirmed lactosuria in both. These observations suggested, not only an abnormal gastric condition, but also duodenal and intestinal mucosal abnormal permeability of lactose. 3. In the case of primary intestinal lymphangiectasia, the subject had a lymphedematous right arm and hand, a grossly coarsened mucosal pattern of the upper gastrointestinal tract (identified via radiologic examination) and the presence of lymphangiectasia (confirmed via duodenal mucosal biopsy). The major laboratory findings were hypoalbuminemia, decreased immunoglobulin levels and lymphopenia resulting from loss of lymph fluid and protein into the gastro

  8. Anatomically ordered tapping interferes more with one-digit addition than two-digit addition: a dual-task fMRI study.

    PubMed

    Soylu, Firat; Newman, Sharlene D

    2016-02-01

    Fingers are used as canonical representations for numbers across cultures. In previous imaging studies, it was shown that arithmetic processing activates neural resources that are known to participate in finger movements. Additionally, in one dual-task study, it was shown that anatomically ordered finger tapping disrupts addition and subtraction more than multiplication, possibly due to a long-lasting effect of early finger counting experiences on the neural correlates and organization of addition and subtraction processes. How arithmetic task difficulty and tapping complexity affect the concurrent performance is still unclear. If early finger counting experiences have bearing on the neural correlates of arithmetic in adults, then one would expect anatomically and non-anatomically ordered tapping to have different interference effects, given that finger counting is usually anatomically ordered. To unravel these issues, we studied how (1) arithmetic task difficulty and (2) the complexity of the finger tapping sequence (anatomical vs. non-anatomical ordering) affect concurrent performance and use of key neural circuits using a mixed block/event-related dual-task fMRI design with adult participants. The results suggest that complexity of the tapping sequence modulates interference on addition, and that one-digit addition (fact retrieval), compared to two-digit addition (calculation), is more affected from anatomically ordered tapping. The region-of-interest analysis showed higher left angular gyrus BOLD response for one-digit compared to two-digit addition, and in no-tapping conditions than dual tapping conditions. The results support a specific association between addition fact retrieval and anatomically ordered finger movements in adults, possibly due to finger counting strategies that deploy anatomically ordered finger movements early in the development.

  9. The aneurysmal arteriovenous fistula - morphological study and assessment of clinical implications. A pilot study.

    PubMed

    Watson, Kenneth R; Gallagher, Maeve; Ross, Rose; Severn, Alison; Nagy, Janos; Cochrane, Lynda; Griffiths, Gareth D

    2015-10-01

    Aneurysmal dilation of arteriovenous fistulae used for haemodialysis is a recognised complication but its clinical significance is a contentious issue. Our aims were to describe aneurysmal fistulae morphologically and clinically.Sixty patients underwent duplex scanning to measure the maximum diameter and skin thickness of their fistula. Haemodialysis function and bleeding risk were assessed clinically.The 75th percentile of maximum diameter was 2.05 cm. In addition to conventional diameter measurement, we describe a novel volume measurement technique which may be of value. No relationship was found between maximum diameter or volume and function, skin thickness or bleeding.Some studies define aneurysm at 2 cm (75th percentile); however, this definition and other arbitrary definitions lack clinical significance. This work suggests that fistula dilation should be considered together with clinical issues when determining the clinical significance of an aneurysm. Our finding that haemodialysis function, skin thickness and bleeding were not associated with diameter needs further study.

  10. Oxidative addition of methane and benzene C--H bonds to rhodium center: A DFT study

    NASA Astrophysics Data System (ADS)

    Bi, Siwei; Zhang, Zhenwei; Zhu, Shufen

    2006-11-01

    A density functional theory study on mechanisms of the oxidative addition of methane and benzene C-H bonds to the rhodium center containing Cp and PMe 3 ligands has been performed. Our calculated results confirm that the C-H bond cleavage from a sigma complex to a hydride alkyl complex is the rate-determining step. Compared with the case of methane C-H bond, the oxidative addition of benzene C-H bond is more favorable kinetically and thermodynamically. Stronger backdonation from metal center to the σ ∗ antibonding orbital of benzene C-H bond is responsible for the observations.

  11. Air pollution and asthma: clinical studies with sulfuric acid aerosols

    SciTech Connect

    Utell, M.J.; Frampton, M.W.; Morrow, P.E. )

    1991-11-01

    Until recently, acid deposition has been widely considered a serious ecological problem but not a threat to human health. The controlled clinical study is an important approach in linking acidic aerosol inhalation with respiratory effects. Asthmatic patients represent a subpopulation most responsive to sulfuric acid aerosols. In a series of studies with asthmatic volunteers, several factors have been identified that may modulate the intensity of the bronchoconstrictor response to inhaled acidic aerosols. We found (1) enhancement of the bronchoconstrictor response during exercise, (2) the more acidic aerosols provoke the greatest changes in lung function, and (3) mitigation of airway responses during sulfuric acid aerosol inhalation caused by high respiratory ammonia concentrations. Additional factors influencing responsiveness await identification.

  12. Lesion removal and lesion addition algorithms in lung volumetric data sets for perception studies

    NASA Astrophysics Data System (ADS)

    Madsen, Mark T.; Berbaum, Kevin S.; Ellingson, Andrew; Thompson, Brad H.; Mullan, Brian F.

    2006-03-01

    Image perception studies of medical images provide important information about how radiologists interpret images and insights for reducing reading errors. In the past, perception studies have been difficult to perform using clinical imaging studies because of the problems associated with obtaining images demonstrating proven abnormalities and appropriate normal control images. We developed and evaluated interactive software that allows the seamless removal of abnormal areas from CT lung image sets. We have also developed interactive software for capturing lung lesions in a database where they can be added to lung CT studies. The efficacy of the software to remove abnormal areas of lung CT studies was evaluated psychophysically by having radiologists select the one altered image from a display of four. The software for adding lesions was evaluated by having radiologists classify displayed CT slices with lesions as real or artificial scaled to 3 levels of confidence. The results of these experiments demonstrated that the radiologist had difficulty in distinguishing the raw clinical images from those that had been altered. We conclude that this software can be used to create experimental normal control and "proven" lesion data sets for volumetric CT of the lung fields. We also note that this software can be easily adapted to work with other tissue besides lung and that it can be adapted to other digital imaging modalities.

  13. A synchrotron study of microstructure gradient in laser additively formed epitaxial Ni-based superalloy

    PubMed Central

    Xue, Jiawei; Zhang, Anfeng; Li, Yao; Qian, Dan; Wan, Jingchun; Qi, Baolu; Tamura, Nobumichi; Song, Zhongxiao; Chen, Kai

    2015-01-01

    Laser additive forming is considered to be one of the promising techniques to repair single crystal Ni-based superalloy parts to extend their life and reduce the cost. Preservation of the single crystalline nature and prevention of thermal mechanical failure are two of the most essential issues for the application of this technique. Here we employ synchrotron X-ray microdiffraction to evaluate the quality in terms of crystal orientation and defect distribution of a Ni-based superalloy DZ125L directly formed by a laser additive process rooted from a single crystalline substrate of the same material. We show that a disorientation gradient caused by a high density of geometrically necessary dislocations and resultant subgrains exists in the interfacial region between the epitaxial and stray grains. This creates a potential relationship of stray grain formation and defect accumulation. The observation offers new directions on the study of performance control and reliability of the laser additive manufactured superalloys. PMID:26446425

  14. A synchrotron study of microstructure gradient in laser additively formed epitaxial Ni-based superalloy

    SciTech Connect

    Xue, Jiawei; Zhang, Anfeng; Li, Yao; Qian, Dan; Wan, Jingchun; Qi, Baolu; Tamura, Nobumichi; Song, Zhongxiao; Chen, Kai

    2015-10-08

    Laser additive forming is considered to be one of the promising techniques to repair single crystal Ni-based superalloy parts to extend their life and reduce the cost. Preservation of the single crystalline nature and prevention of thermal mechanical failure are two of the most essential issues for the application of this technique. Here we employ synchrotron X-ray microdiffraction to evaluate the quality in terms of crystal orientation and defect distribution of a Ni-based superalloy DZ125L directly formed by a laser additive process rooted from a single crystalline substrate of the same material. We show that a disorientation gradient caused by a high density of geometrically necessary dislocations and resultant subgrains exists in the interfacial region between the epitaxial and stray grains. This creates a potential relationship of stray grain formation and defect accumulation. In conclusion, the observation offers new directions on the study of performance control and reliability of the laser additive manufactured superalloys.

  15. Studies of levels of biogenic amines in meat samples in relation to the content of additives.

    PubMed

    Jastrzębska, Aneta; Kowalska, Sylwia; Szłyk, Edward

    2016-01-01

    The impact of meat additives on the concentration of biogenic amines and the quality of meat was studied. Fresh white and red meat samples were fortified with the following food additives: citric and lactic acids, disodium diphosphate, sodium nitrite, sodium metabisulphite, potassium sorbate, sodium chloride, ascorbic acid, α-tocopherol, propyl 3,4,5-trihydroxybenzoate (propyl gallate) and butylated hydroxyanisole. The content of spermine, spermidine, putrescine, cadaverine, histamine, tyramine, tryptamine and 2-phenylethylamine was determined by capillary isotachophoretic methods in meat samples (fresh and fortified) during four days of storage at 4°C. The results were applied to estimate the impact of the tested additives on the formation of biogenic amines in white and red meat. For all tested meats, sodium nitrite, sodium chloride and disodium diphosphate showed the best inhibition. However, cadaverine and putrescine were characterised by the biggest changes in concentration during the storage time of all the additives. Based on the presented data for the content of biogenic amines in meat samples analysed as a function of storage time and additives, we suggest that cadaverine and putrescine have a significant impact on meat quality.

  16. Summary of Previous Chamber or Controlled Anthrax Studies and Recommendations for Possible Additional Studies

    SciTech Connect

    Piepel, Gregory F.; Amidan, Brett G.; Morrow, Jayne B.

    2010-12-29

    This report and an associated Excel file(a) summarizes the investigations and results of previous chamber and controlled studies(b) to characterize the performance of methods for collecting, storing and/or transporting, extracting, and analyzing samples from surfaces contaminated by Bacillus anthracis (BA) or related simulants. This report and the Excel are the joint work of the Pacific Northwest National Laboratory (PNNL) and the National Institute of Standards and Technology (NIST) for the Department of Homeland Security, Science and Technology Directorate. The report was originally released as PNNL-SA-69338, Rev. 0 in November 2009 with limited distribution, but was subsequently cleared for release with unlimited distribution in this Rev. 1. Only minor changes were made to Rev. 0 to yield Rev. 1. A more substantial update (including summarizing data from other studies and more condensed summary tables of data) is underway

  17. Using epidemiology to regulate food additives: saccharin case-control studies.

    PubMed

    Cordle, F; Miller, S A

    1984-01-01

    The increasing use of nonnutritive sweeteners and the widely publicized 1969 ban on cyclamate led to additional investigations in rodents of the carcinogenic potential of saccharin. Preliminary results of a long-term feeding study indicated formation of bladder tumors in rodents, and collective experimental evidence has demonstrated that high doses of the synthetic sweetener saccharin can cause bladder cancer in rodents. Based on the results of that and other rodent studies indicating an increased risk of bladder cancer associated with saccharin, the Commissioner of the Food and Drug Administration announced the agency's intention to propose a ban on saccharin. This intention was made known in April 1977 under the Delaney Clause of the Food, Drug, and Cosmetic Act. The clause essentially states that no additive shall be deemed safe if it is found to induce cancer in man or animals, or if it is found, after tests appropriate for the evaluation of the safety of food additives, to induce cancer in man or animals. Also in 1977, a group of epidemiologists began to assess the available epidemiologic information to determine the potential human risk. This report describes the assessment of several human epidemiologic studies available then and the results of more recent epidemiologic studies.

  18. A kinetic study of struvite precipitation recycling technology with NaOH/Mg(OH)2 addition.

    PubMed

    Yu, Rongtai; Ren, Hongqiang; Wang, Yanru; Ding, Lili; Geng, Jingji; Xu, Ke; Zhang, Yan

    2013-09-01

    Struvite precipitation recycling technology is received wide attention in removal ammonium and phosphate out of wastewater. While past study focused on process efficiency, and less on kinetics. The kinetic study is essential for the design and optimization in the application of struvite precipitation recycling technology. The kinetics of struvite with NaOH/Mg(OH)2 addition were studied by thermogravimetry analysis with three rates (5, 10, 20 °C/min), using Friedman method and Ozawa-Flynn-Wall method, respectively. Degradation process of struvite with NaOH/Mg(OH)2 addition was three steps. The stripping of ammonia from struvite was mainly occurred at the first step. In the first step, the activation energy was about 70 kJ/mol, which has gradually declined as the reaction progress. By model fitting studies, the proper mechanism function for struvite decomposition process with NaOH/Mg(OH)2 addition was revealed. The mechanism function was f(α)=α(α)-(1-α)(n), a Prout-Tompkins nth order (Bna) model.

  19. Combining several ordinal measures in clinical studies.

    PubMed

    Wittkowski, Knut M; Lee, Edmund; Nussbaum, Rachel; Chamian, Francesca N; Krueger, James G

    2004-05-30

    In medical research, it is rare that a single variable is sufficient to represent all relevant aspects of epidemiological risk, genomic activity, adverse events, or clinical response. Since biological systems tend to be neither linear, nor hierarchical in nature, the assumptions of traditional multivariate statistical methods based on the linear model can often not be justified on theoretical grounds. Establishing concept validity through empirical validation is not only problematic, but also time consuming. This paper proposes the use of u-statistics for scoring multivariate ordinal data and a family of simple non-parametric tests for analysis. The scoring method is demonstrated to be applicable to scoring clinical response profiles in the treatment of psoriasis and then to identifying genomic pathways that best correlate with these profiles.

  20. Study of asphalt/asphaltene precipitation during addition of solvents to West Sak crude

    SciTech Connect

    Jiang, J.C.; Patil, S.L.; Kamath, V.A. )

    1990-07-01

    In this study, experimental data on the amount of asphalt and asphaltene precipitation due to addition of solvents to West Sak crude were gathered. The first set of tests were conducted for two types of West Sak stock tank oils. Solvents used include: ethane, carbon dioxide, propane, n-butane, n-pentane, n-heptane, Prudhoe Bay natural gas (PBG) and natural gas liquids (NGL). Effect of solvent to oil dilution ratio on the amount of precipitation was studied. Alteration of crude oil composition due to asphalt precipitation was measured using gas-liquid chromatography. A second set of experiments were conducted to measure asphaltene precipitation due to addition of CO{sub 2} to live (recombined) West Sak crude.

  1. Depersonalization in panic disorder: a clinical study.

    PubMed

    Seguí, J; Márquez, M; García, L; Canet, J; Salvador-Carulla, L; Ortiz, M

    2000-01-01

    Panic disorder (PD) has been hypothesized to be a heterogeneous entity, with distinct clinical subgroups. The presence of depersonalization during panic attacks may distinguish a specific subgroup of PD. We sought to analyze the differential features of a subgroup of PD patients with depersonalization. A total of 274 patients with PD were assessed and divided into 2 groups according to the presence or absence of depersonalization. The Structured Clinical Interview for DSM-III-R (SCID-UP-R) was used to assess PD and comorbid disorders. The clinical scales administered included the Hamilton Anxiety and Depression Rating Scale (HARS and HDRS), the Marks and Mathews Fears and Phobia Scale, Panic-Associated Symptom Scale (PASS), and a panic attack symptoms inventory. A total of 66 patients (24.1%) exhibited depersonalization during the attacks. Patients with depersonalization appeared to be younger and had an earlier age at onset. PD was more severe in the depersonalization group (greater number of attacks, worse level of functioning, and higher scores on most self-rating scales). Also, depersonalization patients showed more comorbidity with specific phobia. Our results support the view that PD with depersonalization may be considered a distinct and more severe subcategory of PD.

  2. Additive effects of neurofeedback on the treatment of ADHD: A randomized controlled study.

    PubMed

    Lee, Eun-Jeong; Jung, Chul-Ho

    2017-02-01

    Neurofeedback (NF) has been identified as a "possibly efficacious" treatment in current evidence-based reviews; therefore, more research is needed to determine its effects. The current study examined the potential additive effect of NF for children diagnosed with ADHD beginning a medication trial first. Thirty-six children (6-12 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to an NF with medication (NF condition) or a medication only condition. Children in the NF group attended 20 twice-weekly sessions. Outcome measures included individual cognitive performance scores (ADS, K-WISC-III), ADHD rating scores completed by their parents (ARS, CRS) and brainwave indices of left and right hemispheres before and after NF treatment. Significant additive treatment effect in any of the symptom variables was found and a reduction of theta waves in both the right and left hemispheres was recorded in NF condition participants. However our randomized controlled study could not demonstrate superior effects of combined NF on intelligent functioning compared to the medication treatment only. This study suggested any possible evidence of positive and additive treatment effects of NF on brainwaves and ADHD symptomatology.

  3. Phytosomal curcumin: A review of pharmacokinetic, experimental and clinical studies.

    PubMed

    Mirzaei, Hamed; Shakeri, Abolfazl; Rashidi, Bahman; Jalili, Amin; Banikazemi, Zarrin; Sahebkar, Amirhossein

    2017-01-01

    Curcumin, a hydrophobic polyphenol, is the principal constituent extracted from dried rhizomes of Curcuma longa L. (turmeric). Curcumin is known as a strong anti-oxidant and anti-inflammatory agent that has different pharmacological effects. In addition, several studies have demonstrated that curcumin is safe even at dosages as high as 8g per day; however, instability at physiological pH, low solubility in water and rapid metabolism results in a low oral bioavailability of curcumin. The phytosomal formulation of curcumin (a complex of curcumin with phosphatidylcholine) has been shown to improve curcumin bioavailability. Existence of phospholipids in phytosomes leads to specific physicochemical properties such as amphiphilic nature that allows dispersion in both hydrophilic and lipophilic media. The efficacy and safety of curcumin phytosomes have been shown against several human diseases including cancer, osteoarthritis, diabetic microangiopathy and retinopathy, and inflammatory diseases. This review focuses on the pharmacokinetics as well as pharmacological and clinical effects of phytosomal curcumin.

  4. TEM and HRTEM studies of ball milled 6061 aluminium alloy powder with Zr addition.

    PubMed

    Lityńska-Dobrzyńska, L; Dutkiewicz, J; Maziarz, W; Rogal, Ł

    2010-03-01

    The effect of mechanical alloying on the microstructure of atomized 6061 aluminium alloy powder and 6061 powder with a zirconium addition was studied in the work. The atomized 6061 aluminium alloy powder and 6061 powder with addition of 2 wt.% Zr were milled in a planetary ball mill and investigated using X-ray diffraction measurements, conventional and high-resolution electron microscopy (TEM/HRTEM) and high-angle annular dark field scanning transmission electron microscopy combined with energy dispersive X-ray microanalysis. An increase of stresses was observed in milled powders after the refinement of crystallites beyond 100 nm. In the powder with zirconium addition, some part of the Zr atoms diffused in aluminium forming a solid solution containing up to 0.5 wt.% Zr. The remaining was found to form Zr-rich particles containing up to 88 wt.% Zr and were identified as face centred cubic (fcc) phase with lattice constant a= 0.48 nm. That fcc phase partially transformed into the L1(2) ordered phase. Eighty-hour milling brought an increase of microhardness (measured with Vickers method) from about 50 HV (168 MPa) for the initial 6061 powder to about 170 HV (552 MPa). The addition of zirconium had no influence on the microhardness.

  5. Comparing the clinical outcomes in patients with atrial fibrillation receiving dual antiplatelet therapy and patients receiving an addition of an anticoagulant after coronary stent implantation

    PubMed Central

    Chaudhary, Nabin; Bundhun, Pravesh Kumar; Yan, He

    2016-01-01

    Abstract Background: Data regarding the clinical outcomes in patients with atrial fibrillation (AF) receiving dual antiplatelet therapy (DAPT) and an anticoagulant in addition to DAPT (DAPT + vitamin K antagonist [VKA]) after coronary stent implantation are still controversial. Therefore, in order to solve this issue, we aim to compare the adverse clinical outcomes in AF patients receiving DAPT and DAPT + VKA after percutaneous coronary intervention and stenting (PCI-S). Methods: Observational studies comparing the adverse clinical outcomes such as major bleeding, major adverse cardiovascular events, stroke, myocardial infarction, all-cause mortality, and stent thrombosis (ST) in AF patients receiving DAPT + VKA therapy, and DAPT after PCI-S have been searched from Medline, EMBASE, and PubMed databases. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to express the pooled effect on discontinuous variables, and the pooled analyses were performed with RevMan 5.3. Results: Eighteen studies consisting of a total of 20,456 patients with AF (7203 patients received DAPT + VKA and 13,253 patients received DAPT after PCI-S) were included in this meta-analysis. At a mean follow-up period of 15 months, the risk of major bleeding was significantly higher in DAPT + VKA group, with OR 0.62 (95% CI 0.50–0.77, P < 0.0001). There was no significant differences in myocardial infarction and major adverse cardiovascular event between DAPT + VKA and DAPT, with OR 1.27 (95% CI 0.92–1.77, P = 0.15) and OR 1.17 (95% CI 0.99–1.39, P = 0.07), respectively. However, the ST, stroke, and all-cause mortality were significantly lower in the DAPT + VKA group, with OR 1.98 (95% CI 1.03–3.81, P = 0.04), 1.59 (95% CI 1.08–2.34, P = 0.02), and 1.41 (95% CI 1.03–1.94, P = 0.03), respectively. Conclusion: At a mean follow-up period of 15 months, DAPT + VKA was associated with significantly lower risk of stroke, ST, and

  6. Community-Based Health Education Programs Designed to Improve Clinical Measures Are Unlikely to Reduce Short-Term Costs or Utilization Without Additional Features Targeting These Outcomes.

    PubMed

    Burton, Joe; Eggleston, Barry; Brenner, Jeffrey; Truchil, Aaron; Zulkiewicz, Brittany A; Lewis, Megan A

    2016-06-07

    Stakeholders often expect programs for persons with chronic conditions to "bend the cost curve." This study assessed whether a diabetes self-management education (DSME) program offered as part of a multicomponent initiative could affect emergency department (ED) visits, hospital stays, and the associated costs for an underserved population in addition to the clinical indicators that DSME programs attempt to improve. The program was implemented in Camden, New Jersey, by the Camden Coalition of Healthcare Providers to address disparities in diabetes care. Data used are from medical records and from patient-level information about hospital services from Camden's hospitals. Using multivariate regression models to control for individual characteristics, changes in utilization over time and changes relative to 2 comparison groups were assessed. No reductions in ED visits, inpatient stays, or costs for participants were found over time or relative to the comparison groups. High utilization rates and costs for diabetes are associated with longer term disease progression and its sequelae; thus, DSME or peer support may not affect these in the near term. Some clinical indicators improved among participants, and these might lead to fewer costly adverse health events in the future. DSME deployed at the community level, without explicit segmentation and targeting of high health care utilizers or without components designed to affect costs and utilization, should not be expected to reduce short-term medical needs for participating individuals or care-seeking behaviors such that utilization is reduced. Stakeholders must include financial outcomes in a program's design if those outcomes are to improve. (Population Health Management 20XX;XX:XXX-XXX).

  7. Self-Esteem, Oral Health Behaviours, and Clinical Oral Health Status in Chinese Adults: An Exploratory Study

    ERIC Educational Resources Information Center

    Chin, Luzy Siu-Hei; Chan, Joanne Chung-Yan

    2013-01-01

    Objectives: This is an exploratory study to examine the relations among self-esteem, oral health behaviours and clinical oral health status in Chinese adults. In addition, gender differences in clinical oral health status and oral health behaviours were explored. Methods: Participants were 192 patients from a private dental clinic in Hong Kong…

  8. [Review of the 2008 revision of the ethical guidelines for clinical studies].

    PubMed

    Imoto, Masakatsu

    2010-05-01

    The ethical guidelines for clinical studies were revised in 2008 and enforced in April 2009. This was the second revision but first regular revision and largely reviewed. In particular, articles under the purview of the Institutional Review Board (IRB) for clinical studies are reviewed and enhanced. This additional role further increases the authority of the IRB, and those who fix the IRB must exhibit the activity of the IRB to the public and report to the MHLW annually. The provision of compensation for clinical studies on the evaluation of drugs and medical devices has been added to this version of the ethical guidelines. The compensation for interventional clinical studies using drugs and medical devices has not yet been decided, similar to "chiken," which is defined in pharmaceutical affairs laws (PAL). Since April 2009, some insurance offices have started offering special insurance covers for clinical studies. New registration rules have been established for clinical studies. Moreover, there is now a database for clinical study registration called "Japan Primary Registries Network (JPRN)," which is certified by WHO. This database comprises 3 open databases, which were originally independent, related to clinical trials in Japan. They are however under the purview of the National Institute of Public Health. This institution works in collaboration with the "International Clinical Trials Registry Platform (ICTRP)" of WHO.

  9. A clinical study of Noonan syndrome.

    PubMed Central

    Sharland, M; Burch, M; McKenna, W M; Paton, M A

    1992-01-01

    Clinical details are presented on 151 individuals with Noonan syndrome (83 males and 68 females, mean age 12.6 years). Polyhydramnios complicated 33% of affected pregnancies. The commonest cardiac lesions were pulmonary stenosis (62%), and hypertrophic cardiomyopathy (20%), with a normal echocardiogram present in only 12.5% of all cases. Significant feeding difficulties during infancy were present in 76% of the group. Although the children were short (50% with a height less than 3rd centile), and underweight (43% with a weight less than 3rd centile), the mean head circumference of the group was on the 50th centile. Motor milestone delay was usual, the cohort having a mean age of sitting unsupported of 10 months and walking of 21 months. Abnormal vision (94%) and hearing (40%) were frequent findings, but 89% of the group were attending normal primary or secondary schools. Other associations included undescended testicles (77%), hepatosplenomegaly (50%), and evidence of abnormal bleeding (56%). The mean age at diagnosis of Noonan syndrome in this group was 9.0 years. Earlier diagnosis of this common condition would aid both clinical management and genetic counselling. Images Figure 1 Figure 2 Figure 3 PMID:1543375

  10. Effect of Exogenous Phytase Addition on Soil Phosphatase Activities: a Fluorescence Spectroscopy Study.

    PubMed

    Yang, Xiao-zhu; Chen, Zhen-hua; Zhang, Yu-lan; Chen, Li-jun

    2015-05-01

    The utilization of organic phosphorus (P) has directly or indirectly improved after exogenous phytase was added to soil. However, the mechanism by which exogenous phytase affected the soil phosphatases (phosphomonoesterase and phosphodiesterase) activities was not clear. The present work was aimed to study red soil, brown soil and cinnamon soil phosphomonoesterase (acid and alkaline) (AcP and AlP) and phosphodiesterase (PD) activities responding to the addition of exogenous phytase (1 g phytase/50 g air dry soil sample) based on the measurements performed via a fluorescence detection method combined with 96 microplates using a TECAN Infinite 200 Multi-Mode Microplate Reader. The results indicated that the acid phosphomonoesterase activity was significantly enhanced in red soil (p≤0. 01), while it was significantly reduced in cinnamon soil; alkaline phosphomonoesterase activity was significantly enhanced in cinnamon soil (p≤ 0. 01), while it was significantly reduced in red soil; phosphodiesterase activity was increased in three soils but it was significantly increased in brown soil (p≤0. 01) after the addition of exogenous phytase. The activities still remained strong after eight days in different soils, which indicated that exogenous phytase addition could be enhance soil phosphatases activities effectively. This effect was not only related to soil properties, such as pH and phosphorus forms, but might also be related to the excreted enzyme amount of the stimulating microorganism. Using fluorescence spectroscopy to study exogenous phytase addition influence on soil phosphatase activities was the first time at home and abroad. Compared with the conventional spectrophotometric method, the fluorescence microplate method is an accurate, fast and simple to use method to determine the relationships among the soil phosphatases activities.

  11. Regression of Atherosclerosis: Insights from Animal and Clinical Studies

    PubMed Central

    Feig, Jonathan E.

    2014-01-01

    Based on studies that extend back to the 1920s, regression and stabilization of atherosclerosis in humans has gone from just a dream to one that is achievable. Review of the literature indicates that the successful attempts at regression generally applied robust measures to improve plasma lipoprotein profiles. Examples include extensive lowering of plasma concentrations of atherogenic apolipoprotein B and enhancement of reverse cholesterol transport from atheromata to the liver. Possible mechanisms responsible for lesion shrinkage include decreased retention of atherogenic apolipoprotein B within the arterial wall, efflux of cholesterol and other toxic lipids from plaques, emigration of lesional foam cells out of the arterial wall, and influx of healthy phagocytes that remove necrotic debris as well as other components of the plaque. However, currently available clinical agents cause less dramatic changes in plasma lipoprotein levels, and thereby fail to stop most cardiovascular events. There is, therefore, a clear need for preclinical and clinical testing of new agents expected to facilitate atherosclerosis regression with the hope that additional mechanistic insights will allow further progress. PMID:24751561

  12. Multimodality molecular imaging--from target description to clinical studies.

    PubMed

    Schober, O; Rahbar, K; Riemann, B

    2009-02-01

    This highlight lecture was presented at the closing session of the Annual Congress of the European Association of Nuclear Medicine (EANM) in Munich on 15 October 2008. The Congress was a great success: there were more than 4,000 participants, and 1,597 abstracts were submitted. Of these, 1,387 were accepted for oral or poster presentation, with a rejection rate of 14%. In this article a choice was made from 100 of the 500 lectures which received the highest scores by the scientific review panel. This article outlines the major findings and trends at the EANM 2008, and is only a brief summary of the large number of outstanding abstracts presented. Among the great number of oral and poster presentations covering nearly all fields of nuclear medicine some headlines have to be defined highlighting the development of nuclear medicine in the 21st century. This review focuses on the increasing impact of molecular and multimodality imaging in the field of nuclear medicine. In addition, the question may be asked as to whether the whole spectrum of nuclear medicine is nothing other than molecular imaging and therapy. Furthermore, molecular imaging will and has to go ahead to multimodality imaging. In view of this background the review was structured according to the single steps of molecular imaging, i.e. from target description to clinical studies. The following topics are addressed: targets, radiochemistry and radiopharmacy, devices and computer science, animals and preclinical evaluations, and patients and clinical evaluations.

  13. [Clinical application of extracts of Echinacea purpurea or Echinacea pallida. Critical evaluation of controlled clinical studies].

    PubMed

    Dorsch, W

    1996-04-01

    The phytotherapy should be understood as being integrated into the rational pharmacotherapy. The modern phytotherapy tries hard to proof effects with pharmacological and clinical studies. The task force E of the federal bureau of health of Germany has made a statement regarding this problem. This article reviews only controlled clinical trials about the application of extracts of echinacea purpura or echinacea pallida.

  14. Oral mucocele: A clinical and histopathological study

    PubMed Central

    More, Chandramani B; Bhavsar, Khushbu; Varma, Saurabh; Tailor, Mansi

    2014-01-01

    Background: Oral mucocele is the most common benign minor (accessory) salivary gland lesion, caused due to mechanical trauma to the excretory duct of the gland. Clinically they are characterized by single or multiple, soft, fluctuant nodule, ranging from the normal color of the oral mucosa to deep blue. It affects at any age and is equally present in both sexes with highest incidence in second decade of life. They are classified as extravasation or retention type. Objectives: To analyze the data between 2010 and 2011 of, clinically and histopathologically diagnosed 58 oral mucoceles for age, gender, type, site, color, cause, symptoms and dimension. Results: Oral mucoceles were highly prevalent in the age group of 15-24 years, were seen in 51.72% of males and 48.28% of females, with a ratio of 1.07:1. The extravasation type (84.48%) was more common than the retention type (15.52%). The most common affected site was lower lip (36.20%) followed by ventral surface of the tongue (25.86%). The lowest frequency was observed in floor of mouth, upper lip and palate. The maximum numbers of mucoceles were asymptomatic (58.62%), and the color of the overlying mucosa had color of adjacent normal mucosa (48.28%). It was also observed that most of the mucoceles had diameter ranging from 5 to 14 mm. The causative factors of the lesion were lip biting (22.41%), trauma (5.18%) and numerous lesions (72.41%). Conclusion: Oral Mucoceles are frequently seen in an oral medicine service, mainly affecting young people and lower lip, measuring around 5 to 14 mm and the extravasation type being the most common. PMID:25364184

  15. An Alternative Study of Transfer of Learning in Clinical Evaluation.

    ERIC Educational Resources Information Center

    Patel, Vimla; Cranton, Patricia A.

    The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

  16. A synchrotron study of microstructure gradient in laser additively formed epitaxial Ni-based superalloy

    DOE PAGES

    Xue, Jiawei; Zhang, Anfeng; Li, Yao; ...

    2015-10-08

    Laser additive forming is considered to be one of the promising techniques to repair single crystal Ni-based superalloy parts to extend their life and reduce the cost. Preservation of the single crystalline nature and prevention of thermal mechanical failure are two of the most essential issues for the application of this technique. Here we employ synchrotron X-ray microdiffraction to evaluate the quality in terms of crystal orientation and defect distribution of a Ni-based superalloy DZ125L directly formed by a laser additive process rooted from a single crystalline substrate of the same material. We show that a disorientation gradient caused bymore » a high density of geometrically necessary dislocations and resultant subgrains exists in the interfacial region between the epitaxial and stray grains. This creates a potential relationship of stray grain formation and defect accumulation. In conclusion, the observation offers new directions on the study of performance control and reliability of the laser additive manufactured superalloys.« less

  17. Does the addition of writing into a pharmacy communication skills course significantly impact student communicative learning outcomes? A pilot study.

    PubMed

    Lonie, John M; Rahim, Hamid

    2010-12-01

    The objective of this study was to determine if the addition of a reflective writing component in a fourth year (P-2) pharmacy communication skills course would significantly affect 2 measures of learning: (1) objective multiple choice examination questions and (2) a patient counseling Objective Structured Clinical Examination (OSCE) score. Using a nonequivalent group quasi-experimental retrospective comparison design, 98 randomly selected final examination scores from students taking a non-writing intensive (NWI) communication skills course were compared with 112 randomly selected final examination scores from students that took a communication skills course in which students engaged in several reflective writing assignments. In addition, 91 randomly selected patient counseling OSCE scores from a NWI course were statistically compared with 112 scores from students that took the writing intensive (WI) course. There were statistically significant improvements in multiple choice examination scores in the group that took the reflective writing communication skills course. There was not a statistically significant difference in patient counseling OSCE scores after students completed the WI course. Studying the effects of using reflective writing assignments in communication skills courses may improve the retention and retrieval of information presented within the course.

  18. C-Reactive Protein in Stable Cystic Fibrosis: An Additional Indicator of Clinical Disease Activity and Risk of Future Pulmonary Exacerbations

    PubMed Central

    Matouk, Elias; Nguyen, Dao; Benedetti, Andrea; Bernier, Joanie; Gruber, James; Landry, Jennifer; Rousseau, Simon; Ahlgren, Heather G; Lands, Larry C; Wojewodka, Gabriella; Radzioch, Danuta

    2016-01-01

    Introduction In stable adult cystic fibrosis (CF) patients, we assessed the role of baseline high sensitivity C-reactive protein (hs-CRP) on CF clinical variables and frequency of intravenous (IV) treated pulmonary exacerbations (PExs) 1-year post-baseline. Methods We recruited 51 clinically stable CF patients from our Adult CF Center. We incorporated collected parameters into Matouk CF clinical score and CF questionnaire-revised quality of life score (QOL). We used the clinical minus complications subscores as a clinical disease activity score (CDAS). We dichotomized our patients according to the cohort median baseline hs-CRP of 5.2 mg/L. Results Patients in the high hs-CRP group (≥ 5.2 mg/L) demonstrated worse CDAS (r=0.67, p=0.0001) and QOL scores (r=0.57, p=0.0017) at a given FEV1% predicted. In both hs-CRP groups, prior-year IV-treated PExs and baseline CDASs were significant predictors of future IV-treated PExs. Interestingly, the association between baseline CDAS and future PExs frequency was more robust in the high compared to the low hs-CRP group (r=−0.88, p<0.0001, r=−0.48, p=0.017, respectively) with a steeper regression slope (p=0.001). In addition, a significant interaction was demonstrated between elevated baseline hs-CRP levels and CDASs for the prediction of increased risk of future PExs (p=0.02). This interaction provided an additional indicator of clinical disease activity and added another dimension to the prior year PExs frequency phenotype to identify patients at increased risk for future PExs. Conclusion Stable CF patients with elevated baseline hs-CRP (≥ 5.2 mg/L) demonstrated worse clinical disease activity and QOL scores at a given level of disease severity (FEV1% predicted). Elevated baseline hs-CRP values combined with clinical disease activity scores are associated with increased risk for future IV-treated PExs even in those with mild clinical disease activity scores. PMID:28066689

  19. A water soluble additive to suppress respirable dust from concrete-cutting chainsaws: a case study.

    PubMed

    Summers, Michael P; Parmigiani, John P

    2015-01-01

    Respirable dust is of particular concern in the construction industry because it contains crystalline silica. Respirable forms of silica are a severe health threat because they heighten the risk of numerous respirable diseases. Concrete cutting, a common work practice in the construction industry, is a major contributor to dust generation. No studies have been found that focus on the dust suppression of concrete-cutting chainsaws, presumably because, during normal operation water is supplied continuously and copiously to the dust generation points. However, there is a desire to better understand dust creation at low water flow rates. In this case study, a water-soluble surfactant additive was used in the chainsaw's water supply. Cutting was performed on a free-standing concrete wall in a covered outdoor lab with a hand-held, gas-powered, concrete-cutting chainsaw. Air was sampled at the operator's lapel, and around the concrete wall to simulate nearby personnel. Two additive concentrations were tested (2.0% and 0.2%), across a range of fluid flow rates (0.38-3.8 Lpm [0.1-1.0 gpm] at 0.38 Lpm [0.1 gpm] increments). Results indicate that when a lower concentration of additive is used exposure levels increase. However, all exposure levels, once adjusted for 3 hours of continuous cutting in an 8-hour work shift, are below the Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) of 5 mg/m(3). Estimates were made using trend lines to predict the fluid flow rates that would cause respirable dust exposure to exceed both the OSHA PEL and the American Conference of Governmental Industrial Hygienists (ACGIH®) threshold limit value (TLV).

  20. Additional Targeted Biopsy in Clinically Suspected Prostate Cancer: Prospective Randomized Comparison between Contrast-Enhanced Ultrasound and Sonoelastography Guidance.

    PubMed

    Koh, Jieun; Jung, Dae Chul; Oh, Young Taik; Yoo, Moon Gyu; Noh, Songmi; Han, Kyung Hwa; Rha, Koon-Ho; Choi, Young Deuk; Hong, Sung Joon

    2015-11-01

    Our aim was to improve the detection of prostate cancer by evaluating whether contrast-enhanced ultrasound (CEUS) or sonoelastography (SE) is more helpful in guiding targeted biopsy (TB) performed before systematic biopsy (SB). A total of 52 patients suspected of having prostate cancer were prospectively included and randomly assigned to either the CEUS or SE group. Different, independent radiologists performed TB and twelve-core SB. Within each group, cancer detection rates based on core number were compared between SB and TB. We evaluated the effect of TB on core-based cancer detection rates between the CEUS and SE groups. Cancer detection was higher in overall TB cores 16.4% (28/171) than SB cores 11.4% (71/624) in both groups. In the SE group, TB cores revealed higher cancer detection than did SB cores from 4.49% (14/312) to 12.86% (9/70) (p = 0.01). Compared with CEUS, SE may improve detection rates when considering additional TB guidance methods.

  1. [Clinical Study of Skull Base Osteomyelitis].

    PubMed

    Ueki, Yushi; Matsuyama, Hiroshi; Morita, Yuka; Takahashi, Kuniyuki; Yamamoto, Yutaka; Takahashi, Sugata

    2015-01-01

    Typical osteomyelitis is reportedly caused by Pseudomonous aeruginosa in elderly diabetic patients after malignant external otitis. Recently, complications have arisen due to the emergence of atypical osteomyelitis. We have experiensed 5 cases of skull base osteomyelitis at our hospital. All patients were male with a mean age of 75.2 years. Four patients had diabetes. Regarding the clinical and radiographic findings, patients 1, 2, and 3 had typical osteomyelitis after malignant external otitis, whereas patients 4 and 5 had atypical osteomyelitis without temporal bone findings. Sample culturing revealed Pseudomonas aeruginosa in 4 cases and Aspergillus in one. Intravenous antibiotics were administered to all patients. Two patients responded positively and survived, while 3 died. Typical osteomyelitis is reportedly caused by P. aeruginosa in elderly diabetic patients after malignant external otitis. Recently, complications have arisen due to the emergence of atypical osteomyelitis. The prognosis of skull base osteomyelitis is still poor in Japan. Early diagnosis and long-term antibiotic administration is required to improve outcome.

  2. Competence of novice nurses: role of clinical work during studying

    PubMed Central

    Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

    2015-01-01

    Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period. PMID:28316703

  3. Competence of novice nurses: role of clinical work during studying.

    PubMed

    Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

    2015-01-01

    Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period.

  4. Towards Data Value-Level Metadata for Clinical Studies.

    PubMed

    Zozus, Meredith Nahm; Bonner, Joseph

    2017-01-01

    While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

  5. An overview of clinical studies on fiber post systems.

    PubMed

    Dikbas, Idil; Tanalp, Jale

    2013-01-01

    Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

  6. Selecting control interventions for clinical outcome studies.

    PubMed

    Barkauskas, Violet H; Lusk, Sally L; Eakin, Brenda L

    2005-04-01

    In the current research environment the design and management of control groups is becoming more complex. The selection of a control group design is dependent on study goals, presence and quality of existing interventions, urgency of the problem or issue being addressed by the intervention, and factors related to the study site. The purpose of the presentation is to identify various approaches to the design of control groups in experimental studies and to identify their strengths, limitations, and applications. A case study exemplifies the issues associated with control group selection and design.

  7. Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

    PubMed Central

    Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

    2017-01-01

    Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

  8. A combined toxicity study of zinc oxide nanoparticles and vitamin C in food additives

    NASA Astrophysics Data System (ADS)

    Wang, Yanli; Yuan, Lulu; Yao, Chenjie; Ding, Lin; Li, Chenchen; Fang, Jie; Sui, Keke; Liu, Yuanfang; Wu, Minghong

    2014-11-01

    At present, safety evaluation standards for nanofood additives are made based on the toxic effects of a single additive. Since the size, surface properties and chemical nature influence the toxicity of nanomaterials, the toxicity may have dramatically changed when nanomaterials are used as food additives in a complex system. Herein, we investigated the combined toxicity of zinc oxide nanoparticles (ZnO NPs) and vitamin C (Vc, ascorbic acid). The results showed that Vc increased the cytotoxicity significantly compared with that of the ZnO only NPs. When the cells were exposed to ZnO NPs at a concentration less than 15 mg L-1, or to Vc at a concentration less than 300 mg L-1, there was no significant cytotoxicity, both in the case of gastric epithelial cell line (GES-1) and neural stem cells (NSCs). However, when 15 mg L-1 of ZnO NPs and 300 mg L-1 of Vc were introduced to cells together, the cell viability decreased sharply indicating significant cytotoxicity. Moreover, the significant increase in toxicity was also shown in the in vivo experiments. The dose of the ZnO NPs and Vc used in the in vivo study was calculated according to the state of food and nutrition enhancer standard. After repeated oral exposure to ZnO NPs plus Vc, the injury of the liver and kidneys in mice has been indicated by the change of these indices. These findings demonstrate that the synergistic toxicity presented in a complex system is essential for the toxicological evaluation and safety assessment of nanofood.At present, safety evaluation standards for nanofood additives are made based on the toxic effects of a single additive. Since the size, surface properties and chemical nature influence the toxicity of nanomaterials, the toxicity may have dramatically changed when nanomaterials are used as food additives in a complex system. Herein, we investigated the combined toxicity of zinc oxide nanoparticles (ZnO NPs) and vitamin C (Vc, ascorbic acid). The results showed that Vc increased the

  9. Rate Constants of Hydroperoxyl Radical Addition to Cyclic Nitrones: A DFT Study

    PubMed Central

    Villamena, Frederick A.; Merle, John K.; Hadad, Christopher M.; Zweier*, Jay L.

    2008-01-01

    Nitrones are potential synthetic antioxidants against the reduction of radical-mediated oxidative damage in cells, and as analytical reagent for the identification of HO2• and other such transient species. In this work, the PCM/B3LYP/6−31+G(d,p)//B3LYP/6−31G(d) and PCM/mPW1K/6−31+G(d,p) density functional theory (DFT) methods were employed to predict the reactivity of HO2• with various functionalized nitrones as spin traps. The calculated second-order rate constants and free energies of reaction at both levels of theory were in the range of 100−103 M−1 s−1 and 1 to −12 kcal mol−1, respectively, and the rate constants for some nitrones are on the same order of magnitude as those observed experimentally. The trend in HO2• reactivity to nitrones could not be explained solely on the basis of the relationship of the theoretical positive charge densities on the nitronyl-C, with their respective ionization potentials, electron affinities, rate constants, or free energies of reaction. However, various modes of intramolecular H-bonding interaction were observed at the transition state (TS) structures of HO2• addition to nitrones. The presence of intramolecular H-bonding interactions in the transition states were predicted and may play a significant role towards a facile addition of HO2• to nitrones. In general, HO2• addition to ethoxycarbonyl- and spirolactam- substituted nitrones, as well as those nitrones without electron-withdrawing substituents, such as 5,5-dimethyl-pyrroline N-oxide (DMPO) and 5-spirocyclopentyl-pyrroline N-oxide (CPPO), are most preferred compared to the methylcarbamoyl-substituted nitrones. This study suggests that the use of specific spin traps for efficient trapping of HO2• could pave the way toward improved radical detection and antioxidant protection. PMID:17845014

  10. A combined toxicity study of zinc oxide nanoparticles and vitamin C in food additives.

    PubMed

    Wang, Yanli; Yuan, Lulu; Yao, Chenjie; Ding, Lin; Li, Chenchen; Fang, Jie; Sui, Keke; Liu, Yuanfang; Wu, Minghong

    2014-12-21

    At present, safety evaluation standards for nanofood additives are made based on the toxic effects of a single additive. Since the size, surface properties and chemical nature influence the toxicity of nanomaterials, the toxicity may have dramatically changed when nanomaterials are used as food additives in a complex system. Herein, we investigated the combined toxicity of zinc oxide nanoparticles (ZnO NPs) and vitamin C (Vc, ascorbic acid). The results showed that Vc increased the cytotoxicity significantly compared with that of the ZnO only NPs. When the cells were exposed to ZnO NPs at a concentration less than 15 mg L(-1), or to Vc at a concentration less than 300 mg L(-1), there was no significant cytotoxicity, both in the case of gastric epithelial cell line (GES-1) and neural stem cells (NSCs). However, when 15 mg L(-1) of ZnO NPs and 300 mg L(-1) of Vc were introduced to cells together, the cell viability decreased sharply indicating significant cytotoxicity. Moreover, the significant increase in toxicity was also shown in the in vivo experiments. The dose of the ZnO NPs and Vc used in the in vivo study was calculated according to the state of food and nutrition enhancer standard. After repeated oral exposure to ZnO NPs plus Vc, the injury of the liver and kidneys in mice has been indicated by the change of these indices. These findings demonstrate that the synergistic toxicity presented in a complex system is essential for the toxicological evaluation and safety assessment of nanofood.

  11. A study of pyrazines in cigarettes and how additives might be used to enhance tobacco addiction

    PubMed Central

    Alpert, Hillel R; Agaku, Israel T; Connolly, Gregory N

    2016-01-01

    Background Nicotine is known as the drug that is responsible for the addicted behaviour of tobacco users, but it has poor reinforcing effects when administered alone. Tobacco product design features enhance abuse liability by (A) optimising the dynamic delivery of nicotine to central nervous system receptors, and affecting smokers’ withdrawal symptoms, mood and behaviour; and (B) effecting conditioned learning, through sensory cues, including aroma, touch and visual stimulation, to create perceptions of pending nicotine reward. This study examines the use of additives called ‘pyrazines’, which may enhance abuse potential, their introduction in ‘lights’ and subsequently in the highly market successful Marlboro Lights (Gold) cigarettes and eventually many major brands. Methods We conducted internal tobacco industry research using online databases in conjunction with published scientific literature research, based on an iterative feedback process. Results Tobacco manufacturers developed the use of a range of compounds, including pyrazines, in order to enhance ‘light’ cigarette products’ acceptance and sales. Pyrazines with chemosensory and pharmacological effects were incorporated in the first ‘full-flavour, low-tar’ product achieving high market success. Such additives may enhance dependence by helping to optimise nicotine delivery and dosing and through cueing and learned behaviour. Conclusions Cigarette additives and ingredients with chemosensory effects that promote addiction by acting synergistically with nicotine, increasing product appeal, easing smoking initiation, discouraging cessation or promoting relapse should be regulated by the US Food and Drug Administration. Current models of tobacco abuse liability could be revised to include more explicit roles with regard to non-nicotine constituents that enhance abuse potential. PMID:26063608

  12. Congenital Rubella: Clinical and Related Studies

    ERIC Educational Resources Information Center

    Menser, Margaret A.

    1977-01-01

    Briefly described are four studies currently being undertaken in Australia to determine the effectiveness of vaccination in the prevention of rubella and to examine the relationship between rubella and diabetes. (CL)

  13. Segmental mediolytic arteritis: a clinical pathologic study.

    PubMed

    Slavin, R E; Gonzalez-Vitale, J C

    1976-07-01

    A distinct arterial lesion was observed in the large abdominal muscular arteries in three autopsied patients. The salient histopathologic feature of this arterial lesion was either partial or total mediolysis. This was accompanied by a linear fibrin deposit between the media and adventitia and a variable nonpleomorphic inflammatory infiltrate. Total mediolysis led to the formation of arterial gaps. Disecting aneurysms frequently occurred and began either adjacent to arterial gaps or as a result of capillary hemorrhages in areas of partial mediolysis. Ruptured aneurysms led to massive intraabdominal hemorrhages. Arterial luminal occlusion, either by thrombi or dissection, resulted in ischemic bowel changes and renal infarcts. In addition, the arteries affected by mediolysis also showed medial degenerative changes, akin to cystic medial necrosis. Concomitant changes in the kidney showed mesangial hyperplasia; the heart exhibited histiocytic infiltrates and rare Aschoff-like bodies and capsular inflammation were seen in the spleen. The pathogenesis of the arterial lesions is unknown. A possible explanation is that this arteritis may have been induced by immune complexes and that local arterial medial degenerative changes predispose the involved arteries to immunologic injury.

  14. A Mechanistic Study of Halogen Addition and Photoelimination from π-Conjugated Tellurophenes.

    PubMed

    Carrera, Elisa I; Lanterna, Anabel E; Lough, Alan J; Scaiano, Juan C; Seferos, Dwight S

    2016-03-02

    The ability to drive reactivity using visible light is of importance for many disciplines of chemistry and has significant implications for sustainable chemistry. Identifying photochemically active compounds and understanding photochemical mechanisms is important for the development of useful materials for synthesis and catalysis. Here we report a series of photoactive diphenyltellurophene compounds bearing electron-withdrawing and electron-donating substituents synthesized by alkyne coupling/ring closing or palladium-catalyzed ipso-arylation chemistry. The redox chemistry of these compounds was studied with respect to oxidative addition and photoelimination of bromine, which is of importance for energy storage reactions involving X2. The oxidative addition reaction mechanism was studied using density functional theory, the results of which support a three-step mechanism involving the formation of an initial η(1) association complex, a monobrominated intermediate, and finally the dibrominated product. All of the tellurophene derivatives undergo photoreduction using 430, 447, or 617 nm light depending on the absorption properties of the compound. Compounds bearing electron-withdrawing substituents have the highest photochemical quantum efficiencies in the presence of an alkene trap, with efficiencies of up to 42.4% for a pentafluorophenyl-functionalized tellurophene. The photoelimination reaction was studied in detail through bromine trapping experiments and laser flash photolysis, and a mechanism is proposed. The photoreaction, which occurs by release of bromine radicals, is competitive with intersystem crossing to the triplet state of the brominated species, as evidenced by the formation of singlet oxygen. These findings should be useful for the design of new photochemically active compounds supported by main-group elements.

  15. Reliability of solar keratosis clinical diagnosis: A prospective study.

    PubMed

    Buinauskaite, Evelina; Makstiene, Jurgita; Buinauskiene, Jurate; Valiukeviciene, Skaidra

    2015-05-01

    Usually solar keratoses (SK) are diagnosed clinically. However other diseases may clinically present as erythematous macules, papules or patches on sun-exposed areas; therefore the histopathology remains the gold standard diagnostic tool. Our study, which assessed the efficacy of photodynamic therapy (PDT), showed that one in 20 clinically diagnosed SK lesions grade I-II identified by board-certified dermatologists were rosacea and only one in 40 were malignant lesions. These findings should be considered by clinicians who treat clinically diagnosed grade I-II SK without response to treatment or diagnose the recurrence of SK after PDT.

  16. [Taxonomic study of clinic isolates of Trichophyton in Rosario, Argentina].

    PubMed

    Tartabini, Mirta L; Bonino, Guillermo S; Racca, Liliana; Luque, Alicia G

    2013-01-01

    Due to the pleomorphism and cultural variability displayed by species of the genus Trichophyton, the identification methods based solely on morphological features are usually insufficient for their classification. The goal of the present work was to test a set of phenotypic methods in order to identify fungal isolates that belong to the aforementioned genus. These methods were based on a molecular taxonomic technique used as standard. Clinical isolates (56) were used as samples along with 6 reference strains. Macro and micromorphological studies were performed as well as biochemical and physiological tests such as in vitro hair perforation, nutritional requirements in Trichophyton agar media, urease production and growth on bromocresol purple-milk. solids-glucose (BCP-MS-G) agar. Additionally, PCR fingerprinting using the (GACA)4 primer was employed. As a result of the PCR method, specific profiles were observed for Microsporum canis, Epidermophyton floccosum, Trichophyton rubrum and Trichophyton interdigitale. Identical profiles were obtained for Arthroderma benhamiae y Trichophyton erinacei. Of the total number of clinical isolates, 39 matched the T. rubrum profile while 13 corresponded to A. benhamiae and 4 to T. interdigitale. The most useful phenotypic test to differentiate between T. rubrum and T. mentagrophytes complex strains was alkalinization of the BCP-MS-G medium. Phenotypic tests did not allow differentiation among the T. mentagrophytes complex species. On the other hand, the molecular technique allowed characterization of T. rubrum isolates as well as of those observed in our study and included in the T. mentagrophytes complex: T. interdigitale and Trichophyton sp., the anamorph of A. benhamiae.

  17. Clinicians’ experiences of becoming a clinical manager: a qualitative study

    PubMed Central

    2012-01-01

    Background There has been an increased interest in recruiting health professionals with a clinical background to management positions in health care. We know little about the factors that influence individuals’ decisions to engage in management. The aim of this study is to explore clinicians’ journeys towards management positions in hospitals, in order to identify potential drivers and barriers to management recruitment and development. Methods We did a qualitative study which included in-depth interviews with 30 clinicians in middle and first-line management positions in Norwegian hospitals. In addition, participant observation was conducted with 20 of the participants. The informants were recruited from medical and surgical departments, and most had professional backgrounds as medical doctors or nurses. Interviews were analyzed by systemic text condensation. Results We found that there were three phases in clinicians’ journey into management; the development of leadership awareness, taking on the manager role and the experience of entering management. Participants’ experiences suggest that there are different journeys into management, in which both external and internal pressure emerged as a recurrent theme. They had not anticipated a career in clinical management, and experienced that they had been persuaded to take the position. Being thrown into the position, without being sufficiently prepared for the task, was a common experience among participants. Being left to themselves, they had to learn management “on the fly”. Some were frustrated in their role due to increasing administrative workloads, without being able to delegate work effectively. Conclusions Path dependency and social pressure seems to influence clinicians’ decisions to enter into management positions. Hospital organizations should formalize pathways into management, in order to identify, attract, and retain the most qualified talents. Top managers should make sure that necessary

  18. Hydrogen atom addition to the surface of graphene nanoflakes: A density functional theory study

    NASA Astrophysics Data System (ADS)

    Tachikawa, Hiroto

    2017-02-01

    Polycyclic aromatic hydrocarbons (PAHs) provide a 2-dimensional (2D) reaction surface in 3-dimensional (3D) interstellar space and have been utilized as a model of graphene surfaces. In the present study, the reaction of PAHs with atomic hydrogen was investigated by means of density functional theory (DFT) to systematically elucidate the binding nature of atomic hydrogen to graphene nanoflakes. PAHs with n = 4-37 were chosen, where n indicates the number of benzene rings. Activation energies of hydrogen addition to the graphene surface were calculated to be 5.2-7.0 kcal/mol at the CAM-B3LYP/6-311G(d,p) level, which is almost constant for all PAHs. The binding energies of hydrogen atom were slightly dependent on the size (n): 14.8-28.5 kcal/mol. The absorption spectra showed that a long tail is generated at the low-energy region after hydrogen addition to the graphene surface. The electronic states of hydrogenated graphenes were discussed on the basis of theoretical results.

  19. Resources allocation in healthcare for cancer: a case study using generalised additive mixed models.

    PubMed

    Musio, Monica; Sauleau, Erik A; Augustin, Nicole H

    2012-11-01

    Our aim is to develop a method for helping resources re-allocation in healthcare linked to cancer, in order to replan the allocation of providers. Ageing of the population has a considerable impact on the use of health resources because aged people require more specialised medical care due notably to cancer. We propose a method useful to monitor changes of cancer incidence in space and time taking into account two age categories, according to healthcar general organisation. We use generalised additive mixed models with a Poisson response, according to the methodology presented in Wood, Generalised additive models: an introduction with R. Chapman and Hall/CRC, 2006. Besides one-dimensional smooth functions accounting for non-linear effects of covariates, the space-time interaction can be modelled using scale invariant smoothers. Incidence data collected by a general cancer registry between 1992 and 2007 in a specific area of France is studied. Our best model exhibits a strong increase of the incidence of cancer along time and an obvious spatial pattern for people more than 70 years with a higher incidence in the central band of the region. This is a strong argument for re-allocating resources for old people cancer care in this sub-region.

  20. Covalent binding of aniline to humic substances. 2. 15N NMR studies of nucleophilic addition reactions

    USGS Publications Warehouse

    Thorn, K.A.; Pettigrew, P.J.; Goldenberg, W.S.; Weber, E.J.

    1996-01-01

    Aromatic amines are known to undergo covalent binding with humic substances in the environment. Although previous studies have examined reaction conditions and proposed mechanisms, there has been no direct spectroscopic evidence for the covalent binding of the amines to the functional groups in humic substances. In order to further elucidate the reaction mechanisms, the Suwannee River and IHSS soil fulvic and humic acids were reacted with 15N-labeled aniline at pH 6 and analyzed using 15N NMR spectrometry. Aniline underwent nucleophilic addition reactions with the quinone and other carbonyl groups in the samples and became incorporated in the form of anilinohydroquinone, anilinoquinone, anilide, imine, and heterocyclic nitrogen, the latter comprising 50% or more of the bound amine. The anilide and anilinohydroquinone nitrogens were determined to be susceptible to chemical exchange by ammonia. In the case of Suwannee River fulvic acid, reaction under anoxic conditions and pretreatment with sodium borohydride or hydroxylamine prior to reaction under oxic conditions resulted in a decrease in the proportion of anilinohydroquinone nitrogen incorporated. The relative decrease in the incorporation of anilinohydroquinone nitrogen with respect to anilinoquinone nitrogen under anoxic conditions suggested that inter- or intramolecular redox reactions accompanied the nucleophilic addition reactions.

  1. Toxicogenomics concepts and applications to study hepatic effects of food additives and chemicals

    SciTech Connect

    Stierum, Rob . E-mail: stierum@voeding.tno.nl; Heijne, Wilbert; Kienhuis, Anne; Ommen, Ben van; Groten, John

    2005-09-01

    Transcriptomics, proteomics and metabolomics are genomics technologies with great potential in toxicological sciences. Toxicogenomics involves the integration of conventional toxicological examinations with gene, protein or metabolite expression profiles. An overview together with selected examples of the possibilities of genomics in toxicology is given. The expectations raised by toxicogenomics are earlier and more sensitive detection of toxicity. Furthermore, toxicogenomics will provide a better understanding of the mechanism of toxicity and may facilitate the prediction of toxicity of unknown compounds. Mechanism-based markers of toxicity can be discovered and improved interspecies and in vitro-in vivo extrapolations will drive model developments in toxicology. Toxicological assessment of chemical mixtures will benefit from the new molecular biological tools. In our laboratory, toxicogenomics is predominantly applied for elucidation of mechanisms of action and discovery of novel pathway-supported mechanism-based markers of liver toxicity. In addition, we aim to integrate transcriptome, proteome and metabolome data, supported by bioinformatics to develop a systems biology approach for toxicology. Transcriptomics and proteomics studies on bromobenzene-mediated hepatotoxicity in the rat are discussed. Finally, an example is shown in which gene expression profiling together with conventional biochemistry led to the discovery of novel markers for the hepatic effects of the food additives butylated hydroxytoluene, curcumin, propyl gallate and thiabendazole.

  2. Evaluation systems for clinical governance development: a comparative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  3. Mental Subnormality in the Community: A Clinical and Epidemiologic Study.

    ERIC Educational Resources Information Center

    Birch, Herbert G.; And Others

    The book reports a clinical and epidemiologic study of the prevalence, distribution, and antecedents of mental subnormality in 8 to 10 year old children living in Aberdeen, Scotland (population 187,000). Utilizing three types of data (differential clinical diagnoses, biological background information, and social characteristics), the study…

  4. Analyzing global trends of biomarker use in drug interventional clinical studies.

    PubMed

    Hayashi, K; Masuda, S; Kimura, H

    2012-04-01

    The trend of biomarker use in drug interventional clinical studies was analyzed using ClinicalTrials.gov to provide an overview of how biomarkers are used to streamline clinical studies and to examine regional differences. A total of 3,383 clinical study data was analyzed according to phase, region, sponsor, and therapeutic class. The number of clinical studies using biomarkers has been increasing constantly and is dependent on the number of Phase I and II studies. The majority of studies (58.5%) were sponsored by the United States, with the studies being conducted mainly in the sponsor's home region (80.3%). The use of biomarkers was prominent in the oncology area (37.1%). Although current data indicates some bias in the clinical use of biomarkers, it is expected that their use will increase in later phase studies or other therapeutic areas as biomarker development proceeds. In addition, limited regional use of biomarkers may lead to differences in biomarker use in drug development and in combination with political support may result in differences in competitiveness of drug development. Biomarkers would be a powerful tool against deteriorating research and development productivity when used more in appropriate clinical study conditions.

  5. Study on Friction and Wear Properties of Silver Matrix Brush Material with Different Additives

    NASA Astrophysics Data System (ADS)

    Chen, Xiaoli; Wang, Wenfang; Hong, Yu; Wu, Yucheng

    2013-07-01

    Friction and wear processes of AgCuX (G, CF and AlN) composites-CuAgV alloy friction pair and effects of different additive content in silver based composite on friction and wear behavior are studied in this paper. The microstructure of the brush wear surface is observed by SEM. The results show that when graphite content is up to 9 wt.%, Ag-Cu-CF-G composite exhibits the best wear properties; when the content of aluminum nitride is up to 0.5 wt.%, Ag-Cu-AlN-G composites has the most comprehensive performance. The wear loss of both composites arises with the increase of both pressure and speed, but when speed reaches a critical value, the increased amplitude of wear loss tends to be steady.

  6. Ribotyping as an additional molecular marker for studying Neisseria meningitidis serogroup B epidemic strains.

    PubMed Central

    Tondella, M L; Sacchi, C T; Neves, B C

    1994-01-01

    The molecular method of ribotyping was used as an additional epidemiological marker to study the epidemic strains of Neisseria meningitidis serogroup B, referred to as the ET-5 complex, responsible for the epidemic which occurred in greater São Paulo, Brazil. Ribotyping analysis of these strains showed only a single rRNA gene restriction pattern (Rb1), obtained with ClaI restriction enzyme. This method, as well as multilocus enzyme electrophoresis, provided useful information about the clonal characteristics of the N. meningitidis serogroup B strains isolated during this epidemic. The N. meningitidis serogroup B isolates obtained from epidemics which occurred in Norway, Chile, and Cuba also demonstrated the same pattern (Rb1). Ribotyping was a procedure which could be applied to a large number of isolates and was felt to be appropriate for routine use in laboratories, especially because of the convenience of using nonradioactive probes. Images PMID:7852566

  7. Spectroscopic studies of nucleic acid additions during seed-mediated growth of gold nanoparticles

    PubMed Central

    Tapp, Maeling; Sullivan, Rick; Dennis, Patrick; Naik, Rajesh R.

    2015-01-01

    The effect of adding nucleic acids to gold seeds during the growth stage of either nanospheres or nanorods was investigated using UV-Vis spectroscopy to reveal any oligonucleotide base or structure-specific effects on nanoparticle growth kinetics or plasmonic signatures. Spectral data indicate that the presence of DNA duplexes during seed ageing drastically accelerated nanosphere growth while the addition of single-stranded polyadenine at any point during seed ageing induces nanosphere aggregation. For seeds added to a gold nanorod growth solution, single-stranded polythymine induces a modest blue-shift in the longitudinal peak wavelength. Moreover, a particular sequence comprised of 50% thymine bases was found to induce a faster, more dramatic blue-shift in the longitudinal peak wavelength compared to any of the homopolymer incubation cases. Monomeric forms of the nucleic acids, however, do not yield discernable spectral differences in any of the gold suspensions studied. PMID:25960601

  8. Modular system for studying tonal sound excitation in resonators with heat addition and mean flow.

    PubMed

    Matveev, Konstantin I; Hernandez, Rafael

    2012-03-01

    An educational experimental system has been developed for studying tonal sound generation in acoustic resonators. Tones are excited by either heat addition or vortex shedding in the presence of mean flow. The system construction is straightforward and inexpensive. Several test arrangements and experimental data are described in this paper. The experimental setups include a modified Rijke tube, a standing-wave thermoacoustic engine, a baffled tube with mean flow, and an acoustic energy harvester with a piezoelement. Simplified mathematical models for interpreting data are discussed, and references are provided to literature with more advanced analyses. The developed system can assist both graduate and undergraduate students in understanding acoustic instabilities via conducting and analyzing interesting experiments.

  9. Genetic Assessment of Additional Endophenotypes from the Consortium on the Genetics of Schizophrenia Family Study

    PubMed Central

    Greenwood, Tiffany A.; Lazzeroni, Laura C.; Calkins, Monica E.; Freedman, Robert; Green, Michael F.; Gur, Raquel E.; Gur, Ruben C.; Light, Gregory A.; Nuechterlein, Keith H.; Olincy, Ann; Radant, Allen D.; Seidman, Larry J.; Siever, Larry J.; Silverman, Jeremy M.; Stone, William S.; Sugar, Catherine A.; Swerdlow, Neal R.; Tsuang, Debby W.; Tsuang, Ming T.; Turetsky, Bruce I.; Braff, David L.

    2015-01-01

    The Consortium on the Genetics of Schizophrenia Family Study (COGS-1) has previously reported our efforts to characterize the genetic architecture of 12 primary endophenotypes for schizophrenia. We now report the characterization of 13 additional measures derived from the same endophenotype test paradigms in the COGS-1 families. Nine of the measures were found to discriminate between schizophrenia patients and controls, were significantly heritable (31 to 62%), and were sufficiently independent of previously assessed endophenotypes, demonstrating utility as additional endophenotypes. Genotyping via a custom array of 1536 SNPs from 94 candidate genes identified associations for CTNNA2, ERBB4, GRID1, GRID2, GRIK3, GRIK4, GRIN2B, NOS1AP, NRG1, and RELN across multiple endophenotypes. An experiment-wide p value of 0.003 suggested that the associations across all SNPs and endophenotypes collectively exceeded chance. Linkage analyses performed using a genome-wide SNP array further identified significant or suggestive linkage for six of the candidate endophenotypes, with several genes of interest located beneath the linkage peaks (e.g., CSMD1, DISC1, DLGAP2, GRIK2, GRIN3A, and SLC6A3). While the partial convergence of the association and linkage likely reflects differences in density of gene coverage provided by the distinct genotyping platforms, it is also likely an indication of the differential contribution of rare and common variants for some genes and methodological differences in detection ability. Still, many of the genes implicated by COGS through endophenotypes have been identified by independent studies of common, rare, and de novo variation in schizophrenia, all converging on a functional genetic network related to glutamatergic neurotransmission that warrants further investigation. PMID:26597662

  10. Mössbauer spectroscopy: an excellent additional tool for the study of magnetic soils and sediments

    NASA Astrophysics Data System (ADS)

    Vandenberghe, R. E.; Hus, J. J.; de Grave, E.

    2009-04-01

    Since the discovery a half century ago of the resonant gamma absorption, known as the Mössbauer effect, the derived spectroscopic method (MS) has proven to be a very suitable tool for the characterization of soil and rock minerals. From the conventional absorption spectra of iron containing compounds, so-called hyperfine parameters are derived which are more or less typical for each kind of mineral. So, MS has a certain analytical power for the characterization of iron-bearing minerals. This is especially true for magnetic minerals for which the spectrum contains an additional hyperfine parameter. Moreover, MS also allows retrieving information about the magnetic structure and behavior. Because the relative area of the spectra is to some extent proportional to the amount of iron atoms in their environment, MS yields not only quantitative information about the various minerals present but also about the iron in the different crystallographic sites. The power of MS as an excellent additional tool for the study of magnetic soils and sediments could be well demonstrated in the joint research with Jozef Hus (CPG-IRM, Dourbes). In our common work, the emphasis went mainly to the study of Chinese loess and soils. Using MS on magnetically separated samples the various magnetic species in a loess and its associated soil were for the first time discerned in a direct way. Further, magnetically enriched samples of four different loess/paleosol couplets from a loess sequence in Huangling have been systematically investigated by MS. From the obtained qualitative and quantitative information the neoformation of magnetite/maghemite in the soils, responsible for the increased observed remanence and susceptibility, could be evidenced.

  11. Spin-probe ESR and molecular modeling studies on calcium carbonate dispersions in overbased detergent additives.

    PubMed

    Montanari, Luciano; Frigerio, Francesco

    2010-08-15

    Oil-soluble calcium carbonate colloids are used as detergent additives in lubricating oils. They are colloidal dispersions of calcium carbonate particles stabilized by different surfactants; in this study alkyl-aryl-sulfonates and sulfurized alkyl-phenates, widely used in the synthesis of these additives, are considered. The physical properties of surfactant layers surrounding the surfaces of calcium carbonate particles were analyzed by using some nitroxide spin-probes (stable free radicals) and observing the corresponding ESR spectra. The spin-probe molecules contain polar groups which tend to tether them to the carbonate particle polar surface. They can reach these surfaces only if the surfactant layers are not very compact, hence the relative amounts of spin-probe molecules accessing carbonate surfaces are an index of the compactness of surfactant core. ESR signals of spin-probe molecules dissolved in oil or "locked" near the carbonate surfaces are different because of the different molecular mobility. Through deconvolution of the ESR spectra, the fraction of spin-probes penetrating surfactant shells have been calculated, and differences were observed according to the surfactant molecular structures. Moreover, by using specially labeled spin-probes based on stearic acids, functionalized at different separations from the carboxylic acid group, it was possible to interrogate the molecular physical behavior of surfactant shells at different distances from carbonate surfaces. Molecular modeling was applied to generate some three-dimensional micellar models of the colloidal stabilizations of the stabilized carbonate particles with different molecular structures of the surfactant. The diffusion of spin-probe molecules into the surfactant shells were studied by applying a starting force to push the molecules towards the carbonate surfaces and then observing the ensuing behavior. The simulations are in accordance with the ESR data and show that the geometrical

  12. A clinical pathologic study of mercurialentis medicamentosus.

    PubMed Central

    Garron, L K; Wood, I S; Spencer, W H; Hayes, T L

    1976-01-01

    Thirty-one patients who used eye drops containing the preservative, phenylmercuric nitrate for from 3 to 15 years, developed a brownish pigmentation of the anterior capsule of the pupillary area. Light and electron microscopic studies on two lenses demonstrated deposits of dense particulate material resembling melanin pigment on and in the anterior capsule of the lens in the area of the pupil. Special studies, including electron microprobe analysis and neutron activation analysis established the presence of mercury in a lens with mercurialentis. No mercury was found in two lenses used as controls. Images FIGURE 1 FIGURE 2 A FIGURE 2 B FIGURE 3 FIGURE 4 A FIGURE 4 B FIGURE 5 FIGURE 6 FIGURE 7 FIGURE 8 FIGURE 9 A FIGURE 9 B FIGURE 9 C PMID:867632

  13. Clinical study of histologically proven conjunctival cysts

    PubMed Central

    Thatte, Shreya; Jain, Jagriti; Kinger, Mallika; Palod, Sapan; Wadhva, Jatin; Vishnoi, Avijit

    2014-01-01

    Purpose This is a clinco-histopathological study of different varieties of conjunctival cysts where modification of surgical technique was done as per requirement for intact removal of cysts to minimise recurrence rate. Materials and methods Retrospective study of 40 cases of conjunctival cysts. A thorough ocular examination and basic haematological work up was done for all patients. B-scan USG and MRI was done wherever required to see the posterior extent. All patients underwent surgical excision of cyst followed by histo-pathological examination. Results The various types of conjunctival cysts found in our study were primary inclusion cyst 12 (30%), secondary inclusion cyst 6 (15%), pterygium with cysts 15 (37.5%), parasitic cyst 4 (10%), lymphatic cyst 2 (5%), and orbital cyst with rudimentary eye 1 (2.5%). The common symptoms noted were progressive increase in size of cyst (39.45%), cosmetic disfigurement (26.23%), foreign body sensations (27.86%), proptosis (1.6%), ocular motility restrictions (3.2%) and decreased visual acuity (1.6%). The patients were followed till one year after surgical excision for any recurrence and complications and no recurrence was seen. Conclusion Careful and intact removal of conjunctival cyst is important to prevent recurrence. Minor modifications in surgical technique according to the size, site and nature of cyst help in intact removal and prevent recurrence. PMID:25892928

  14. Clinical pearls: factors affecting reported contraceptive efficacy rates in clinical studies.

    PubMed

    Burkman, Ronald T

    2002-01-01

    Current combination oral contraceptives (OCs) are among the most popular, safe, and effective methods of reversible contraception. There are, however, many factors that can affect contraceptive failure rates as reported in clinical trials, including subject characteristics, factors related to study methodology and data analysis, and publication biases. The variability of these factors among clinical trials makes meaningful comparisons of contraceptive efficacy data across studies difficult, if not misleading or erroneous. It is even more difficult to reconcile the differences between clinical trial efficacy rates and everyday use rates; for instance, the National Survey of Family Growth reported that the rate of OC failure is close to 8% in the United States, which is higher than rates reported in clinical trials. Thus, it is important for the clinician to consider the many factors that can influence reporting of contraceptive failure rates in clinical trials and be aware of the limitations in differentiating OCs on the basis of contraceptive efficacy derived from clinical trial data. Furthermore, clinical trial data may not accurately predict contraceptive efficacy in everyday use.

  15. The impact of bismuth addition to sequential treatment on Helicobacter pylori eradication: A pilot study.

    PubMed

    Basyigit, Sebahat; Kefeli, Ayse; Sapmaz, Ferdane; Yeniova, Abdullah Ozgür; Asilturk, Zeliha; Hokkaomeroglu, Murat; Uzman, Metin; Nazligul, Yasar

    2015-10-25

    The success of the current anti-Helicobacter pylori (H. pylori) treatment protocols is reported to decrease by years, and research is needed to strengthen the H. pylori eradication treatment. Sequential treatment (ST), one of the treatment modalities for H. pylori eradication, includes amoxicillin 1 gr b.i.d and proton pump inhibitor b.i.d for first 5 days and then includes clarithromycin 500 mg b.i.d, metronidazole 500 mg b.i.d and a proton pump inhibitor b.i.d for remaining 5 days. In this study, we investigated efficacy and tolerability of bismuth addition in to ST. We included patients that underwent upper gastrointestinal endoscopy in which H. pylori infection was diagnosed by histological examination of antral and corporal gastric mucosa biopsy. Participants were randomly administered ST or bismuth containing ST (BST) protocols for the first-line H. pylori eradication therapy. Participants have been tested by urea breath test for eradication success 6 weeks after the completion of treatment. One hundred and fifty patients (93 female, 57 male) were enrolled. There were no significant differences in eradication rates for both intention to treat population (70.2%, 95% confidence interval [CI]: 66.3-74.1% vs. 71.8%, 95% CI: 61.8-81.7%, for ST and BST, respectively, p>0.05) and per protocol population (74.6%, 95% CI: 63.2-85.8% vs. 73.7%, 95% CI: 63.9-83.5% for ST and BST, respectively, p>0.05). Despite the undeniable effect of bismuth, there may be several possible reasons of unsatisfactory eradication success. Drug administration time, coadministration of other drugs, possible H. pylori resistance to bismuth may affect the eradication success. The addition of bismuth subcitrate to ST regimen does not provide significant increase in eradication rates.

  16. Experimental Study of Disruption of Columnar Grains During Rapid Solidification in Additive Manufacturing

    NASA Astrophysics Data System (ADS)

    Manogharan, Guha; Yelamanchi, Bharat; Aman, Ronald; Mahbooba, Zaynab

    2016-03-01

    Over the years, many studies have been conducted to study and analyze the grain structures of metal alloys during additive manufacturing to improve mechanical properties. In particular, columnar grains are observed predominantly during rapid solidification of molten metal. This leads to lower mechanical properties and requires expensive secondary heat-treatment processes. This study is aimed at disrupting the formation of columnar grain growth during rapid solidification using ultrasonic vibration and analyzes the effects on grain structure and mechanical properties. A gas-metal arc welder mounted on a Rep-Rap-based low-cost metal 3 Dimension printer was used to deposit ER70S-6 mild steel layers on a plate. A contact-type ultrasonic transducer with a control system to vary the frequency and power of the vibration was used. The effects of ultrasonic vibration were determined from the statistical analysis of microstructure and micro-indentation techniques on the deposited layer and heat-affected zone. It was found that both frequency and interaction between frequency and power had significant impact on the refinement of average grain size up to 10.64% and increased the number of grains by approximately 41.78%. Analysis of micro-indentation tests showed that there was an increase of approximately 14.30% in micro-hardness due to the applied frequency during rapid solidification. A pole diagram shows that application of vibration causes randomization of grain orientation. Along with the results from this study, further efforts in modeling and experimentation of multi-directional vibrations would lead to a better understanding of disrupting columnar grains in applications that use mechanical vibrations, such as welding, directed energy deposition, brazing, etc.

  17. Percutaneous Dorsal Instrumentation of Vertebral Burst Fractures: Value of Additional Percutaneous Intravertebral Reposition—Cadaver Study

    PubMed Central

    Krüger, Antonio; Schmuck, Maya; Noriega, David C.; Ruchholtz, Steffen; Baroud, Gamal; Oberkircher, Ludwig

    2015-01-01

    Purpose. The treatment of vertebral burst fractures is still controversial. The aim of the study is to evaluate the purpose of additional percutaneous intravertebral reduction when combined with dorsal instrumentation. Methods. In this biomechanical cadaver study twenty-eight spine segments (T11-L3) were used (male donors, mean age 64.9 ± 6.5 years). Burst fractures of L1 were generated using a standardised protocol. After fracture all spines were allocated to four similar groups and randomised according to surgical techniques (posterior instrumentation; posterior instrumentation + intravertebral reduction device + cement augmentation; posterior instrumentation + intravertebral reduction device without cement; and intravertebral reduction device + cement augmentation). After treatment, 100000 cycles (100–600 N, 3 Hz) were applied using a servohydraulic loading frame. Results. Overall anatomical restoration was better in all groups where the intravertebral reduction device was used (p < 0.05). In particular, it was possible to restore central endplates (p > 0.05). All techniques decreased narrowing of the spinal canal. After loading, clearance could be maintained in all groups fitted with the intravertebral reduction device. Narrowing increased in the group treated with dorsal instrumentation. Conclusions. For height and anatomical restoration, the combination of an intravertebral reduction device with dorsal instrumentation showed significantly better results than sole dorsal instrumentation. PMID:26137481

  18. Evaluating the addition of positive reinforcement for learning a frightening task: a pilot study with horses.

    PubMed

    Heleski, Camie; Bauson, Laura; Bello, Nora

    2008-01-01

    Horse training often relies upon negative reinforcement (NR). This study tested the hypothesis that adding positive reinforcement (PR) to NR would enhance learning in horses (n = 34) being taught to walk over a tarp (novel/typically frightening task). Subjects were Arabians, and the same person handled all of them. This person handled half "traditionally" (NR only)--that is, halter/lead were pulled; when horse stepped forward, pressure was released; process repeated until criterion met (horse crossed the tarp with little/no obvious anxiety). The same person handled the other half traditionally--but with addition of PR < food + verbal praise > (NR + PR). Subjects "failed" the task if they refused to walk onto the tarp after 10 min. Nine horses failed; 6 of 9 failures were from NR only--no significant difference detected (p = .41). The study detected no difference in time to first crossing of the tarp (p = .30) or total time to achieve calmness criterion (p = .67). Overall, adding PR did not significantly enhance learning this task. However, there were practical implications--adding PR made the task safer/less fatiguing for the handler.

  19. Synthesis, Characterization, Molecular Modeling, and DNA Interaction Studies of Copper Complex Containing Food Additive Carmoisine Dye.

    PubMed

    Shahabadi, Nahid; Akbari, Alireza; Jamshidbeigi, Mina; Khodarahmi, Reza

    2016-06-02

    A copper complex of carmoisine dye; [Cu(carmoisine)2(H2O)2]; was synthesized and characterized by using physico-chemical and spectroscopic methods. The binding of this complex with calf thymus (ct) DNA was investigated by circular dichroism, absorption studies, emission spectroscopy, and viscosity measurements. UV-vis results confirmed that the Cu complex interacted with DNA to form a ground-state complex and the observed binding constant (2× 10(4) M(-1)) is more in keeping with the groove bindings with DNA. Furthermore, the viscosity measurement result showed that the addition of complex causes no significant change on DNA viscosity and it indicated that the intercalation mode is ruled out. The thermodynamic parameters are calculated by van't Hoff equation, which demonstrated that hydrogen bonds and van der Waals interactions played major roles in the reaction. The results of circular dichroism (CD) suggested that the complex can change the conformation of DNA from B-like form toward A-like conformation. The cytotoxicity studies of the carmoisine dye and its copper complex indicated that both of them had anticancer effects on HT-29 (colon cancer) cell line and they may be new candidates for treatment of the colon cancer.

  20. Density functional theory study of the effects of alloying additions on sulfur adsorption on nickel surfaces

    NASA Astrophysics Data System (ADS)

    Malyi, Oleksandr I.; Chen, Zhong; Kulish, Vadym V.; Bai, Kewu; Wu, Ping

    2013-01-01

    Reactions of hydrogen sulfide (H2S) with Nickel/Ytrria-doped zirconia (Ni/YDZ) anode materials might cause degradation of the performance of solid oxide fuel cells when S containing fuels are used. In this paper, we employ density functional theory to investigate S adsorption on metal (M)-doped and undoped Ni(0 0 1) and Ni(1 1 1) surfaces. Based on the performed calculations, we analyze the effects of 12 alloying additions (Ag, Au, Al, Bi, Cd, Co, Cu, Fe, Sn, Sb, V, and Zn) on the temperature of transition between clean (S atoms do not adsorb on the surfaces) and contaminated (S atoms can adsorb on the surfaces spontaneously) M-doped Ni surfaces for different concentrations of H2S in the fuel. Predicted results are consistent with many experimental studies relevant to S poisoning of both Ni/YDZ and M-doped Ni/YDZ anode materials. This study is important to understand S poisoning phenomena and to develop new S tolerant anode materials.

  1. An fMRI study of magnitude comparison and exact addition in children.

    PubMed

    Meintjes, Ernesta M; Jacobson, Sandra W; Molteno, Christopher D; Gatenby, J Christopher; Warton, Christopher; Cannistraci, Christopher J; Gore, John C; Jacobson, Joseph L

    2010-04-01

    By contrast to the adult literature, in which a consistent parietofrontal network for number processing has been identified, the data from studies of number processing in children have been less consistent, probably due to differences in study design and control conditions. Number processing was examined using functional magnetic resonance imaging in 18 right-handed children (8-12 years) from the Cape Coloured community in Cape Town, South Africa, using Proximity Judgment and Exact Addition (EA) tasks. The findings were consistent with the hypothesis that, as in adults, the anterior horizontal intraparietal sulcus (HIPS) plays a major role in the representation and manipulation of quantity in children. The posterior medial frontal cortex, believed to be involved in performance monitoring in more complex arithmetic manipulations in adults, was extensively activated even for relatively simple symbolic number processing in the children. Other areas activated to a greater degree in the children included the left precentral sulcus, which may mediate number knowledge and, for EA, the head of the caudate nucleus, which is part of a fronto-subcortical circuit involved in the behavioral execution of sequences. Two regions that have been linked to number processing in adults - the angular gyrus and posterior superior parietal lobule - were not activated in the children. The data are consistent with the inference that although the functional specialization of the anterior HIPS may increase as symbolic number processing becomes increasingly automatic, this region and other elements of the parietofrontal network identified in adults are already reliably and robustly activated by middle childhood.

  2. MIH: epidemiologic clinic study in paediatric patient

    PubMed Central

    CONDÒ, R.; PERUGIA, C.; MATURO, P.; DOCIMO, R.

    2012-01-01

    SUMMARY The Molar Incisor Hypomineralization (MIH) is a qualitative and quantitative defect of the enamel structure of the first permanent molars, which may vary from 1 to 4 with involvement of maxillary and jaw permanent incisors. Aim. Aim of this study is that to evaluate, among 1500 paediatric patients chosen at random aged between 0 and 14 years, afferent by the Paediatric Dentistry of the Azienda Ospedialiera Policlinico Tor Vergata of Rome from 1996 to 2011, the incidents and the prevalence of the MIH distribution, and furthermore to ascertain the possible relationship with the data described in the literature. Results and discussion. From the sample of 1500 paediatric patients, the number of those affections from MIH has turned out to be pairs to 110 (7.3%) aged between 4 and 15 years, and an average age equal to 9.7. The incidence of the hypoplastic defects is greater in the elements of the permanents series in which the functional class mainly interested is that of the first molars, with a percentage of 39.8%. Regarding the elements of the deciduous series affections from hypoplasia, they turn out to be in all in number of 20 represented in 80% of the cases from the seconds molars while in the remaining 20% of the cases the items involved are the central incisors. About the percentage of elements involved in the MIH: the molars, involved with a frequency of 56%, turn out to be more hit regarding incisors (44%). As reported in the literature, it can be asserted that the MIH can hit in equal measure both the male sex that feminine one. Conclusions. MIH represents a condition quite frequent in the paediatric population. In managing this anomaly takes an essential role in the early diagnosis and in the differential one. The study done underlined the importance of a correct application of the therapeutic protocol which, starting from a careful diagnosis and articulating themselves in the execution of preventive treatments and in severe cases restorative and

  3. Autoalloplast. An experimental and clinical study.

    PubMed

    Stucker, F J

    1982-03-01

    The concept of an autoalloplast offers the convenience of an alloplast and the safety and reliability of an autograft. An alloplast that acts as a scaffold for fibrous tissue ingrowth retains many of the characteristics of an autograft when reimplanted. Fibrous encapsulation is essential to the retention of all implanted impermeable synthetic materials. They then retain a potential for extrusion. Polyamide mesh, which allows the ingrowth of fibrous tissue, is a synthetic implant that circumvents the potential for extrusion. The fibrous tissue ingrowth provides substance to the graft, which permits precise carving with a scalpel after the initial implantation into a vascular area. A suitable period is necessary to allow fibrous tissue ingrowth. The incorporated mesh material is then harvested, shaped, and reimplanted into the augmentation site as an autoalloplast. A three-phase animal study to determine the feasibility of the autoalloplast concept is presented. It showed that fibrous incorporation of polyamide mesh occurs, and harvesting and reimplantation were feasible. It also demonstrated the superiority of the autoalloplast to withstand trauma without extrusion when compared with autogenous cartilage, polyamide mesh without fibrous assimilation, and Silastic. Since 1974, twenty-one humans have received successful implants with the autoalloplast. The patients have been followed up for two to 7 1/2 years, with all cases successful to date. The prospect of nurturing and biologically assimilating an implant in a safe and controlled area of a host and its subsequent reimplantation expands the field of reconstructive surgery and offers a practical method for managing certain facial deformities.

  4. Theoretical study of ignition reactions of linear symmetrical monoethers as potential diesel fuel additives: DFT calculations

    NASA Astrophysics Data System (ADS)

    Marrouni, Karim El; Abou-Rachid, Hakima; Kaliaguine, Serge

    This work investigates the chemical reactivity of four linear symmetrical monoethers with molecular oxygen. Such oxygenated compounds may be considered as potential diesel fuel additives in order to reduce the ignition delay in diesel fuel engines. For this purpose, a kinetic study is proposed to clarify the relation between the molecular structure of the fuel molecule and its ignition properties. To this end, DFT calculations were performed for these reactions using B3LYP/6-311G(d,p) and BH&HLYP/6-311G(d,p) to determine structures, energies, and vibrational frequencies of stationary points as well as activated complexes involved in each gas-phase combustion initiation reaction of the monoethers CH3OCH3, C2H5OC2H5, C3H7OC3H7, or C4H9OC4H9 with molecular oxygen. This theoretical kinetic study was carried out using electronic structure results and the transition state theory, to assess the rate constants for all studied combustion reactions. As it has been shown in our previous work [Abou-Rachid et al., J Mol Struct (Theochem) 2003, 621, 293], the cetane number (CN) of a pure organic molecule depends on the initiation rate of its homogeneous gas-phase reaction with molecular oxygen. Indeed, the calculated initiation rate constants of the H-abstraction process of linear monoethers with O2 show a very good correlation with experimental CN data of these pure compounds at T D 1,000 K. This temperature is representative of the operating conditions of a diesel fuel engine.0

  5. Experimental study of enhanced heat transfer by addition of CuO nanoparticle

    NASA Astrophysics Data System (ADS)

    Jesumathy, Stella; Udayakumar, M.; Suresh, S.

    2012-06-01

    An energy storage system has been designed to study the thermal characteristics of paraffin wax with an embedded nano size copper oxide (CuO) particle. This paper presents studies conducted on phase transition times, heat fraction as well as heat transfer characteristics of paraffin wax as phase change material (PCM) embedded with CuO nanoparticles. 40 nm mean size CuO particles of 2, 5 and 10% by weight were dispersed in PCM for this study. Experiments were performed on a heat exchanger with 1.5-10 l/min of heat transfer fluid (HTF) flow. Time-based variations of the temperature distributions are revealed from the results of observations of melting and solidification curves. The results strongly suggested that the thermal conductivity enhances 6, 6.7 and 7.8% in liquid state and in dynamic viscosity it enhances by 5, 14 and 30% with increasing mass fraction of the CNEPs. The thermal conductivity ratio of the composites can be augmented by a factor up to 1.3. The heat transfer coefficient during solidification increased about 78% for the maximum flow rate. The analysis of experimental results reveals that the addition of copper oxide nanoparticles to the paraffin wax enhances both the conduction and natural convection very effectively in composites and in paraffin wax. The paraffin wax-based composites have great potential for energy storage applications like industrial waste heat recovery, solar thermal applications and solar based dynamic space power generation with optimal fraction of copper oxide nanoparticles.

  6. Clinical evaluation of hypnotic drugs: contributions from sleep laboratory studies.

    PubMed

    Kales, A; Scharf, M B; Soldatos, C R; Bixler, E O

    1979-07-01

    The most thorough and clinically relevant approach to hypnotic drug evaluation is one that balances the strengths and weaknesses of clinical trials and sleep laboratory evaluations. Advantages of clinical trials include the ability to evaluate large numbers of subjects and specific target groups and to thoroughly assess and quantify a drug's side effects, whereas sleep laboratory studies are very limited in all of these areas. Sleep laboratory studies however provide a rigorous, precise, and comprehensive profile of a drug's activity since there is more control over experimental variables and measurements are objective as well as continuous throughout the night. These benefits offset the shortcomings of clinical trials, which include a lack of objective measurements, less control over experimental variables, failure to evaluate a drug's effectiveness with continued use, and inattention to drug interaction and withdrawal effect. Several basic principles derived from sleep laboratory findings have been incorporated into both the clinical trials and sleep laboratory evaluations recommended in the new FDA Guidelines for the Clinical Evaluation of Hypnotic Drugs. These principles include provision for adequate baseline and withdrawal periods, use of multiple consecutive drug nights to assess a drug's effectiveness with continued use, and inclusion of an adequate washout period when a cross-over design is used. The guidelines do not emphasize either clinical trials or sleep laboratory studies at the expense of each other, but rather stress their complementary utilization.

  7. Microneedle delivery: clinical studies and emerging medical applications.

    PubMed

    Pettis, Ronald J; Harvey, Alfred J

    2012-03-01

    The concept of microneedle drug delivery was described three decades ago; however, effective clinical demonstration has only occurred within the past 10-15 years. Substantial progress in microneedle design and fabrication including extensive in vitro, ex vivo, and in vivo preclinical evaluation with various drugs, vaccines and other agents has transpired over the last decade. In contrast with this large volume of preclinical data, there are relatively few published microneedle clinical studies. To date, the clinical investigative focus has included testing to reduce dermal barrier properties and enhance transdermal delivery; evaluation of enhanced vaccine antigenicity, including development of the first commercial microneedle product for intradermal influenza vaccination; evaluation of altered microneedle protein pharmacokinetics and pharmacodynamics, especially for insulin; and evaluation of the pain and other perceptions associated with microneedle usage. This review summarizes the various aspects of microneedle clinical evaluation to date and identifies areas requiring further clinical evaluation.

  8. Enhancing Patient Safety Using Clinical Nursing Data: A Pilot Study.

    PubMed

    Choi, Jeeyae; Choi, Jeungok E

    2016-01-01

    To enhance patient safety from falls, many hospital information systems have been implemented to collect clinical data from the bedside and have used the information to improve fall prevention care. However, most of them use administrative data not clinical nursing data. This necessitated the development of a web-based Nursing Practice and Research Information Management System (NPRIMS) that processes clinical nursing data to measure nurses' delivery of fall prevention care and its impact on patient outcomes. This pilot study developed computer algorithms based on a falls prevention protocol and programmed the prototype NPRIMS. It successfully measured the performance of nursing care delivered and its impact on patient outcomes using clinical nursing data from the study site. Results of the study revealed that NPRIMS has the potential to pinpoint components of nursing processes that are in need of improvement for preventing patient from falls.

  9. Practicing nurses perspectives of clinical scholarship: a qualitative study

    PubMed Central

    2013-01-01

    Background There is a scarcity of research published on clinical scholarship. Much of the conceptualisation has been conducted in the academy. Nurse academics espouse that the practice of nursing must be built within a framework of clinical scholarship. A key concept of clinical scholarship emerging from discussions in the literature is that it is an essential component of enabling evidence–based nursing and the development of best practice standards to provide for the needs of patients/clients. However, there is no comprehensive definition of clinical scholarship from the practicing nurses. The aim of this study was to contribute to this definitional discussion on the nature of clinical scholarship in nursing. Methods Naturalistic inquiry informed the method. Using an interpretative approach 18 practicing nurses from Australia, Canada and England were interviewed using a semi-structured format. The audio-taped interviews were transcribed and the text coded for emerging themes. The themes were sorted into categories and the components of clinical scholarship described by the participants compared to the scholarship framework of Boyer [JHEOE 7:5-18, 2010]. Results Clinical scholarship is difficult to conceptualise. Two of the essential elements of clinical scholarship are vision and passion. The other components of clinical scholarship were building and disseminating nursing knowledge, sharing knowledge, linking academic research to practice and doing practice-based research. Conclusion Academic scholarship dominated the discourse in nursing. However, in order for nursing to develop and to impact on health care, clinical scholarship needs to be explored and theorised. Nurse educators, hospital-based researchers and health organisations need to work together with academics to achieve this goal. Frameworks of scholarship conceptualised by nurse academics are reflected in the findings of this study with their emphasis on reading and doing research and translating it

  10. Beyond the Call of Duty: A Qualitative Study of Teachers' Additional Responsibilities Related to Sexuality Education

    ERIC Educational Resources Information Center

    Eisenberg, Marla E.; Madsen, Nikki; Oliphant, Jennifer A.; Resnick, Michael

    2011-01-01

    Seven focus groups were conducted with sexuality educators in Minnesota to explore ways that teaching sexuality education differs from teaching other health education content and to determine if additional supports or resources are needed for sexuality educators. Teachers described many specific additional responsibilities or concerns related to…

  11. Additional Language Teaching within the International Baccalaureate Primary Years Programme: A Comparative Study

    ERIC Educational Resources Information Center

    Lebreton, Marlène

    2014-01-01

    The International Baccalaureate Primary Years Programme supports the learning of languages and cultures, but the role of the additional language within this programme is often unclear. There remains a great variability in schools regarding the frequency of lessons and the way that the additional language is taught within the Primary Years…

  12. Meiofaunal and bacterial community response to diesel additions in a microcosm study.

    PubMed

    Lindgren, J Fredrik; Hassellöv, Ida-Maja; Dahllöf, Ingela

    2012-03-01

    Effects of low PAH-containing diesel were studied in a 60-day microcosm experiment at PAH concentrations 130, 1300 and 13,000μg/kg sediment. Nutrient fluxes, potential nitrification and meiofaunal community composition were analysed at three time points. Changed ∑NOx-fluxes indicated reduced sediment nitrification in Medium and High with time, in agreement with lowered potential nitrification rates in all treatments. Reduction in silicate and phosphate fluxes over time suggested severe effects on activity of meiofauna. Reduced activity increased the anoxic sediment layer, which could have contributed to the changed ∑NOx-fluxes. There were significant differences in meiofaunal community composition after 30 and 60days in Medium and High. Changes were due to increasing numbers of harpacticoids and the foraminiferan group Rotaliina, as well as decreasing numbers of Nematodes and the foraminiferan group Reophax. In spite of the low PAH-level, small additions of this diesel can still have pronounced effects on meiofaunal and bacterial communities.

  13. Experimental study of combustion characteristics of nanoscale metal and metal oxide additives in biofuel (ethanol)

    PubMed Central

    2011-01-01

    An experimental investigation of the combustion behavior of nano-aluminum (n-Al) and nano-aluminum oxide (n-Al2O3) particles stably suspended in biofuel (ethanol) as a secondary energy carrier was conducted. The heat of combustion (HoC) was studied using a modified static bomb calorimeter system. Combustion element composition and surface morphology were evaluated using a SEM/EDS system. N-Al and n-Al2O3 particles of 50- and 36-nm diameters, respectively, were utilized in this investigation. Combustion experiments were performed with volume fractions of 1, 3, 5, 7, and 10% for n-Al, and 0.5, 1, 3, and 5% for n-Al2O3. The results indicate that the amount of heat released from ethanol combustion increases almost linearly with n-Al concentration. N-Al volume fractions of 1 and 3% did not show enhancement in the average volumetric HoC, but higher volume fractions of 5, 7, and 10% increased the volumetric HoC by 5.82, 8.65, and 15.31%, respectively. N-Al2O3 and heavily passivated n-Al additives did not participate in combustion reactively, and there was no contribution from Al2O3 to the HoC in the tests. A combustion model that utilized Chemical Equilibrium with Applications was conducted as well and was shown to be in good agreement with the experimental results. PMID:21711760

  14. A theoretical study of wave dispersion and thermal conduction for HMX/additive interfaces

    NASA Astrophysics Data System (ADS)

    Long, Yao; Chen, Jun

    2014-04-01

    The wave dispersion rule for non-uniform material is useful for ultrasonic inspection and engine life prediction, and also is key in achieving an understanding of the energy dissipation and thermal conduction properties of solid material. On the basis of linear response theory and molecular dynamics, we derive a set of formulas for calculating the wave dispersion rate of interface systems, and study four kinds of interfaces inside plastic bonded explosives: HMX/{HMX, TATB, F2312, F2313}. (HMX: octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine; TATB: 1,3,5-triamino-2,4,6-trinitrobenzene; F2312, F2313: fluoropolymers). The wave dispersion rate is obtained over a wide frequency range from kHz to PHz. We find that at low frequency, the rate is proportional to the square of the frequency, and at high frequency, the rate couples with the molecular vibration modes at the interface. By using the results, the thermal conductivities of HMX/additive interfaces are derived, and a physical model is built for describing the total thermal conductivity of mixture explosives, including HMX multi-particle systems and {TATB, F2312, F2313}-coated HMX.

  15. Tackling missing data in community health studies using additive LS-SVM classifier.

    PubMed

    Wang, Guanjin; Deng, Zhaohong; Choi, Kup-Sze

    2016-12-01

    Missing data is a common issue in community health and epidemiological studies. Direct removal of samples with missing data can lead to reduced sample size and information bias, which deteriorates the significance of the results. While data imputation methods are available to deal with missing data, they are limited in performance and could introduce noises into the dataset. Instead of data imputation, a novel method based on additive least square support vector machine (LS-SVM) is proposed in this paper for predictive modeling when the input features of the model contain missing data. The method also determines simultaneously the influence of the features with missing values on the classification accuracy using the fast leave-one-out cross-validation strategy. The performance of the method is evaluated by applying it to predict the quality of life (QOL) of elderly people using health data collected in the community. The dataset involves demographics, socioeconomic status, health history and the outcomes of health assessments of 444 community-dwelling elderly people, with 5% to 60% of data missing in some of the input features. The QOL is measured using a standard questionnaire of the World Health Organization. Results show that the proposed method outperforms four conventional methods for handling missing data - case deletion, feature deletion, mean imputation and K-nearest neighbor imputation, with the average QOL prediction accuracy reaching 0.7418. It is potentially a promising technique for tackling missing data in community health research and other applications.

  16. [Analysis on evaluation tool for literature quality in clinical study].

    PubMed

    Liu, Qing; Zhai, Wei; Tan, Ya-qin; Huang, Juan

    2014-09-01

    The tools used for the literature quality evaluation are introduced. The common evaluation tools that are publicly and extensively used for the evaluation of clinical trial literature quality in the world are analyzed, including Jadad scale, Consolidated Standards of Reporting Trials (CONSORT) statement and Grades of Recommendations Assessment, Development and Evaluation (GRADE) system and the others. Additionally, the present development, updates and applications of these tools are involved in analysis.

  17. The need for annual echocardiography to detect cabergoline-associated valvulopathy in patients with prolactinoma: a systematic review and additional clinical data.

    PubMed

    Caputo, Carmela; Prior, David; Inder, Warrick J

    2015-11-01

    Present recommendations by the US Food and Drug Administration advise that patients with prolactinoma treated with cabergoline should have an annual echocardiogram to screen for valvular heart disease. Here, we present new clinical data and a systematic review of the scientific literature showing that the prevalence of cabergoline-associated valvulopathy is very low. We prospectively assessed 40 patients with prolactinoma taking cabergoline. Cardiovascular examination before echocardiography detected an audible systolic murmur in 10% of cases (all were functional murmurs), and no clinically significant valvular lesion was shown on echocardiogram in the 90% of patients without a murmur. Our systematic review identified 21 studies that assessed the presence of valvular abnormalities in patients with prolactinoma treated with cabergoline. Including our new clinical data, only two (0·11%) of 1811 patients were confirmed to have cabergoline-associated valvulopathy (three [0·17%] if possible cases were included). The probability of clinically significant valvular heart disease is low in the absence of a murmur. On the basis of these findings, we challenge the present recommendations to do routine echocardiography in all patients taking cabergoline for prolactinoma every 12 months. We propose that such patients should be screened by a clinical cardiovascular examination and that echocardiogram should be reserved for those patients with an audible murmur, those treated for more than 5 years at a dose of more than 3 mg per week, or those who maintain cabergoline treatment after the age of 50 years.

  18. Nursing Students' Clinical Experience With Death: A Pilot Study.

    PubMed

    Heise, Barbara A; Gilpin, Laura C

    2016-01-01

    Although debriefing in simulation settings is routine in nursing education, debriefing does not routinely take place in clinical settings with nursing students after a patient has died. This pilot study sought to explore nursing students' perceptions of their first experience with the death of a patient. Students reported emotional distress and feelings of inadequacy with regard to communicating with and supporting the family of the dying patient. Only half the students sampled reported debriefing by their clinical instructor or staff. Nurse educators must include debriefing and student support following a patient death in the clinical setting.

  19. Fosfomycin tromethamine in uncomplicated urinary tract infections: a clinical study.

    PubMed

    Bonfiglio, Giovanni; Mattina, Roberto; Lanzafame, Antonina; Cammarata, Esmeralda; Tempera, Gianna

    2005-05-01

    The aim of our study was to verify if the empiric therapy with a single dose of 3 g fosfomycin tromethamine in patients with uncomplicated urinary tract infections (UTIs) was able to clinically resolveand to microbiologically eradicate the infection. A total of 387 out of the 400 patients (274 cases with acute and 113 cases with recurrent uncomplicated UTIs) were enrolled in the clinical study. Clinical and microbiological assessments were performed before and at 8-10 days after the administration. At follow-up high clinical recovery (88.9%) and bacteriological (94.9%) eradication rates were achieved. Gastrointestinal side effects were found in only 4.3% of patients. In conclusion, a single-dose administration regimen of fosfomycin tromethamine should be encouraged as a first choice of drug therapy for uncomplicated UTIs.

  20. Strengthening the Regression Discontinuity Design Using Additional Design Elements: A Within-Study Comparison

    ERIC Educational Resources Information Center

    Wing, Coady; Cook, Thomas D.

    2013-01-01

    The sharp regression discontinuity design (RDD) has three key weaknesses compared to the randomized clinical trial (RCT). It has lower statistical power, it is more dependent on statistical modeling assumptions, and its treatment effect estimates are limited to the narrow subpopulation of cases immediately around the cutoff, which is rarely of…

  1. Contact allergy to colophony. Clinical and experimental studies with emphasis on clinical relevance.

    PubMed

    Färm, G

    1998-01-01

    Colophony--also called rosin--is a material obtained from coniferous trees. It is used widely in many products, particularly because of its good tackifying properties. Colophony is also used in paper sizing to increase water resistance. Colophony may cause contact allergy, and around 5% of Swedish dermatitis patients show allergic reactions to colophony at patch testing. There are many case reports of colophony in different products causing contact dermatitis. Often, however, the clinical relevance of a positive patch-test reaction to colophony is difficult to evaluate. The principal aims of the present thesis were to study the prevalence of contact allergy to colophony and of skin disease in individuals with an occupational exposure to colophony; to study the prognosis of dermatitis in colophony-sensitive subjects, and to investigate the outcome of repeated open applications of colophony, thereby trying to elucidate the clinical relevance of contact allergy to colophony. Employees of a tall-oil rosin (colophony) factory (n = 180), and of an opera company where colophony was used in dancers' rosin, mascara and wig glues (n = 132), were interviewed, examined and patch tested. 3.9% and 2% of these two groups respectively had a positive patch test to colophony. More than every fourth participant showed some kind of skin disease, but only few cases were related to work. Eighty-three patients with previously diagnosed contact allergy to colophony were followed-up 72% showed a positive patch-test reaction to colophony at re-testing. Around one third had hand eczema. There was no significant correlation between colophony exposure and current hand eczema. Adhesive bandages containing colophony and zinc oxide (ZnO), colophony and mixes of colophony and ZnO, were tested in 7 colophony-sensitive subjects to see whether addition of zinc oxide inhibited elicitation of allergic dermatitis to colophony, which has been proposed. No difference in reactivity between colophony and

  2. Does Addition of Propolis to Glass Ionomer Cement Alter its Physicomechanical Properties? An In Vitro Study.

    PubMed

    Subramaniam, P; Girish Babu, K L; Neeraja, G; Pillai, S

    Propolis is a natural resinous substance produced by honey bees. The antimicrobial effects of glass ionomer cement have been shown to improve with the addition of propolis; however its effect on the physicomechanical properties of the cement is not known.

  3. Comparative Studies of Cathodically-Promoted and Base-Catalyzed Michael Addition Reactions of Levoglucosenone.

    PubMed

    Samet, Alexander V.; Niyazymbetov, Murat E.; Semenov, Victor V.; Laikhter, Andrei L.; Evans, Dennis H.

    1996-12-13

    Regioselective Michael addition of nitro and heterocyclic compounds to levoglucosenone, 1, is effectively catalyzed by amines and also by cathodic electrolysis. In comparison to the base-catalyzed reaction, it was found that under electrochemical conditions the reaction proceeds under milder conditions and with higher yields. Cathodically-initiated Michael addition of thiols to levoglucosenone using small currents produces the previously unknown threo addition product in several instances. The normal erythro isomer, identified as the kinetic product, tends to be formed when large currents are used. In contrast, slow, low current electrolyses promote equilibration of the two forms so that erythro can be converted to threo by the retro reaction and readdition. Addition of 2-naphthalenethiol to (R)-(+)-apoverbenone is also reported.

  4. Study of metal whiskers growth and mitigation technique using additive manufacturing

    NASA Astrophysics Data System (ADS)

    Gullapalli, Vikranth

    For years, the alloy of choice for electroplating electronic components has been tin-lead (Sn-Pb) alloy. However, the legislation established in Europe on July 1, 2006, required significant lead (Pb) content reductions from electronic hardware due to its toxic nature. A popular alternative for coating electronic components is pure tin (Sn). However, pure tin has the tendency to spontaneously grow electrically conductive Sn whisker during storage. Sn whisker is usually a pure single crystal tin with filament or hair-like structures grown directly from the electroplated surfaces. Sn whisker is highly conductive, and can cause short circuits in electronic components, which is a very significant reliability problem. The damages caused by Sn whisker growth are reported in very critical applications such as aircraft, spacecraft, satellites, and military weapons systems. They are also naturally very strong and are believed to grow from compressive stresses developed in the Sn coating during deposition or over time. The new directive, even though environmentally friendly, has placed all lead-free electronic devices at risk because of whisker growth in pure tin. Additionally, interest has occurred about studying the nature of other metal whiskers such as zinc (Zn) whiskers and comparing their behavior to that of Sn whiskers. Zn whiskers can be found in flooring of data centers which can get inside electronic systems during equipment reorganization and movement and can also cause systems failure. Even though the topic of metal whiskers as reliability failure has been around for several decades to date, there is no successful method that can eliminate their growth. This thesis will give further insights towards the nature and behavior of Sn and Zn whiskers growth, and recommend a novel manufacturing technique that has potential to mitigate metal whiskers growth and extend life of many electronic devices.

  5. Chemostat Studies of TCE-Dehalogenating Anaerobic Consortia under Excess and Limited Electron Donor Addition

    NASA Astrophysics Data System (ADS)

    Semprini, L.; Azizian, M.; Green, J.; Mayer-Blackwell, K.; Spormann, A. M.

    2015-12-01

    Two cultures - the Victoria Strain (VS) and the Evanite Strain (EV), enriched with the organohalide respiring bacteria Dehalococcoides mccartyi - were grown in chemostats for more than 4 years at a mean cell residence time of 50 days. The slow doubling rate represents growth likely experienced in the subsurface. The chemostats were fed formate as an electron donor and trichloroethene (TCE) as the terminal electron acceptor. Under excess formate conditions, stable operation was observed with respect to TCE transformation, steady-state hydrogen (H2) concentrations (40 nM), and the structure of the dehalogenating community. Both cultures completely transformed TCE to ethene, with minor amounts of vinyl chloride (VC) observed, along with acetate formation. When formate was limited, TCE was transformed incompletely to ethene (40-60%) and VC (60- 40%), and H2 concentrations ranged from 1 to 3 nM. The acetate concentration dropped below detection. Batch kinetic studies of TCE transformation with chemostat harvested cells found transformation rates of c-DCE and VC were greatly reduced when the cells were grown with limited formate. Upon increasing formate addition to the chemostats, from limited to excess, essentially complete transformation of TCE to ethene was achieved. The increase in formate was associated with an increase in H2 concentration and the production of acetate. Results of batch kinetic tests showed increases in transformation rates for TCE and c-DCE by factors of 3.5 and 2.5, respectively, while VC rates increased by factors of 33 to 500, over a six month period. Molecular analysis of chemostat samples is being performed to quantify the changes in copy numbers of reductase genes and to determine whether shifts in the strains of Dehalococcoides mccartyi where responsible for the observed rate increases. The results demonstrate the importance of electron donor supply for successful in-situ remediation.

  6. Did the addition of concomitant chemotherapy to radiotherapy improve outcomes in hypopharyngeal cancer? A population-based study

    PubMed Central

    Hall, S.F.; Griffiths, R.

    2016-01-01

    Background For oncologists and for patients, no site-specific clinical trial evidence has emerged for the use of concurrent chemotherapy with radiotherapy (ccrt) over radiotherapy (rt) alone for cancer of the hypopharynx (hpc) or for other human papilloma virus–negative head-and-neck cancers. Methods This retrospective population-based cohort study using administrative data compared treatments over time (1990–2000 vs. 2000–2010), treatment outcomes, and outcomes over time in 1333 cases of hpc diagnosed in Ontario between January 1990 and December 2010. Results The incidence of hpc is declining; the use of ccrt that began in 2001 is increasing; and the 3-year overall survival for all patients remains poor at 34.6%. No difference in overall survival was observed in a comparison of patients treated in the decade before ccrt and of patients treated in the decade during the uptake of ccrt. Conclusions The addition of ccrt to the armamentarium of treatment options for oncologists treating head-and-neck patients did not improve outcomes for hpc at the population level. PMID:27536177

  7. Autologous temporomandibular joint reconstruction independent of exogenous additives: a proof-of-concept study for guided self-generation

    PubMed Central

    Wei, Jiao; Herrler, Tanja; Han, Dong; Liu, Kai; Huang, Rulin; Guba, Markus; Dai, Chuanchang; Li, Qingfeng

    2016-01-01

    Joint defects are complex and difficult to reconstruct. By exploiting the body’s own regenerative capacity, we aimed to individually generate anatomically precise neo-tissue constructs for autologous joint reconstruction without using any exogenous additives. In a goat model, CT scans of the mandibular condyle including articular surface and a large portion of the ascending ramus were processed using computer-aided design and manufacturing. A corresponding hydroxylapatite negative mold was printed in 3D and temporarily embedded into the transition zone of costal periosteum and perichondrium. A demineralized bone matrix scaffold implanted on the contralateral side served as control. Neo-tissue constructs obtained by guided self-generation exhibited accurate configuration, robust vascularization, biomechanical stability, and function. After autologous replacement surgery, the constructs showed stable results with similar anatomical, histological, and functional findings compared to native controls. Further studies are required to assess long-term outcome and possible extensions to other further applications. The absence of exogenous cells, growth factors, and scaffolds may facilitate clinical translation of this approach. PMID:27892493

  8. A Comparison of Dimensional Accuracy of Addition Silicone of Different Consistencies with Two Different Spacer Designs - In-vitro Study

    PubMed Central

    Eswaran, B; Eswaran, MA; Prabhu, R; Geetha, KR; Krishna, GP; Jagadeshwari

    2014-01-01

    Introduction: Dimensional accuracy of impression materials is crucial for the production of working casts in Fixed Prosthodontics. The accurate replication of tooth preparations and their arch position requires impression materials that exhibit limited distortion. Methods: This study was conducted to comparatively evaluate the dimensional accuracy of additional silicones by comparing two different techniques and spacer designs, by measuring the linear changes in interpreparation distance. The impressions were made from a stainless steel master die simulating a three unit bridge. A total 80 die stone (type IV, Ultrarock) models were obtained from the impressions made using two different parameters. The two different parameters are Multimix and Monophasic technique and different spacer designs. Result: The interpreparation distance of the abutments in the casts was measured using a travelling microscope. Each sample was measured thrice and the mean value was calculated. The results obtained were statistically analysed and the values fall within the clinically acceptable range. Conclusion: The most accurate combination is multimix technique with spacer design which uses less bulk of impression material. PMID:25177635

  9. 78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... Anti- Salmonella Chemical Food Additives in Feeds; Request for Comments AGENCY: Food and Drug... revising the guidance entitled ``Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella... Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in...

  10. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies

    PubMed Central

    O’Donnell, Lauren A.; Perry, Michael W.; Doup, Dane’t R.

    2015-01-01

    For many students in the health sciences, including doctor of pharmacy (PharmD) students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions), and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course. PMID:26753029

  11. A study of patients who go to a psychology clinic seeking treatment.

    PubMed

    Estupiñá, Francisco José; Labrador, Francisco Javier; García-Vera, María Paz

    2012-03-01

    In order to characterize a typical clinical context, as opposed to an academic or research context, this article will analyze the sociodemographic and clinical characteristics of patients who turn to a psychology clinic in need of professional help. This study was conducted using an initial sample of 1,305 patients at the Universidad Complutense de Madrid (UCM) Clínica Universitaria de Psicología. Of the sociodemographic characteristics studied, it is noteworthy that the majority of patients were women (65%) and relatively young (the average age is 29.7 years-old). The disorders for which psychological help was most often needed were anxiety and mood disorders and relationship problems, which together made up 50% of cases. In 17.70% of cases, patients had at least one comorbid disorder in addition to the one that brought them to the clinic. The generalizability and implications of the results are discussed.

  12. Clinica use of platelet additive solutions.

    PubMed

    van Rhenen, Dick J

    2007-12-01

    Randomised clinical trial (RCT) to study the clinical efficacy and safety of new platelet products using platelet additive solutions are scarce. In this paper a number of recent RCT's is discussed. It can be the start of a development where new transfusion products enter a RCT before the product is applied in clinical practice.

  13. Can ligand addition to soil enhance Cd phytoextraction? A mechanistic model study.

    PubMed

    Lin, Zhongbing; Schneider, André; Nguyen, Christophe; Sterckeman, Thibault

    2014-11-01

    Phytoextraction is a potential method for cleaning Cd-polluted soils. Ligand addition to soil is expected to enhance Cd phytoextraction. However, experimental results show that this addition has contradictory effects on plant Cd uptake. A mechanistic model simulating the reaction kinetics (adsorption on solid phase, complexation in solution), transport (convection, diffusion) and root absorption (symplastic, apoplastic) of Cd and its complexes in soil was developed. This was used to calculate plant Cd uptake with and without ligand addition in a great number of combinations of soil, ligand and plant characteristics, varying the parameters within defined domains. Ligand addition generally strongly reduced hydrated Cd (Cd(2+)) concentration in soil solution through Cd complexation. Dissociation of Cd complex ([Formula: see text]) could not compensate for this reduction, which greatly lowered Cd(2+) symplastic uptake by roots. The apoplastic uptake of [Formula: see text] was not sufficient to compensate for the decrease in symplastic uptake. This explained why in the majority of the cases, ligand addition resulted in the reduction of the simulated Cd phytoextraction. A few results showed an enhanced phytoextraction in very particular conditions (strong plant transpiration with high apoplastic Cd uptake capacity), but this enhancement was very limited, making chelant-enhanced phytoextraction poorly efficient for Cd.

  14. Expert views on clinical supervision: a study based on interviews.

    PubMed

    Severinsson, E I; Borgenhammar, E V

    1997-05-01

    Clinical supervision is a didactic process of the purpose of human development and maturity. The aim of this study is to analyse views on clinical supervision held by a number of experts, and to reflect on the effects and value of clinical supervision in relation to public health. Data were collected by interviews and analysed in accordance with the grounded theory construction model. The results showed that clinical supervision is an integration process guiding a person from 'novice to expert' by establishing a relationship of trust between supervisor and supervisee. This study indicates that implementation of systematic clinical supervision may positively affect quality of care, and patients' recovery, create improved feeling of confidence in one's work, and prevent burnout among staff. The negative aspects, as reported, were the possibility of high 'opportunity costs', e.g. the time loss for patient care by those participating in organized systematic supervision. On the other hand, clinical supervision contributes towards more efficient use of resources and hence avoids unnecessary costs. However, neither of these aspects were further elaborated on by the experts but clearly indicate an important field for further research.

  15. Chlorhexidine varnish implemented treatment strategy for chronic periodontitis: A clinical and microbial study

    PubMed Central

    Manikandan, D.; Balaji, V. R.; Niazi, Tanvir Mohamad; Rohini, G.; Karthikeyan, B.; Jesudoss, P.

    2016-01-01

    Aim: The aim of the present study was to evaluate the short-term clinical and microbiological effect of chlorhexidine varnish when used as an adjuvant to scaling and root planing in the treatment of chronic periodontitis. Materials and Methods: A split-mouth design was conducted in 11 patients suffering from chronic periodontitis. The control site underwent scaling and root planing, and the experimental site was additionally treated with chlorhexidine varnish application. Clinical parameters, namely, gingival index (GI), plaque index (PI), bleeding on probing (BoP), probing pocket depth (PPD), and clinical attachment level were recorded at baseline, 1 month, and 3 months postoperatively. Furthermore, microbial examination of the plaque samples was done at baseline, 1 month, and 3 months. Results: Both treatment strategies showed significant improvement in GI, PI, BoP, PPD, and clinical attachment level, at both follow-up visits by comparison with baseline levels. At study termination, chlorhexidine varnish implemented treatment strategy resulted in additional improvement in the clinical parameters, and more reduction in the total anaerobic count at 1 month and 3 months. Conclusions: These findings suggest that a chlorhexidine varnish implemented treatment strategy along with scaling and root planing may improve the clinical outcome for the treatment of chronic periodontitis in comparison to scaling and root planing alone. PMID:27829764

  16. Mechanical characterization of filler sandcretes with rice husk ash additions. Study applied to Senegal

    SciTech Connect

    Cisse, I.K.; Laquerbe, M.

    2000-01-01

    To capitalize on the local materials of Senegal (agricultural and industrial wastes, residual fines from crushing process, sands from dunes, etc.), rise husk ash and residues of industrial and agricultural wastes have been used as additions in sandcretes. The mechanical resistance of sandcrete blocks obtained when unground ash (and notably the ground ash) is added reveals that there is an increase in performance over the classic mortar blocks. In addition, the use of unground rice husk ash enables production of a lightweight sandcrete with insulating properties, at a reduced cost. The ash pozzolanic reactivity explains the high strengths obtained.

  17. Rethinking clinical governance: healthcare professionals’ views: a Delphi study

    PubMed Central

    Veenstra, Gepke L; Ahaus, Kees; Welker, Gera A; Heineman, Erik; van der Laan, Maarten J; Muntinghe, Friso L H

    2017-01-01

    Objective Although the guiding principle of clinical governance states that healthcare professionals are the leading contributors to quality and safety in healthcare, little is known about what healthcare professionals perceive as important for clinical governance. The aim of this study is to clarify this by exploring healthcare professionals' views on clinical governance. Design Based on a literature search, a list of 99 elements related to clinical governance was constructed. This list was refined, extended and restricted during a three-round Delphi study. Setting and participants The panel of experts was formed of 24 healthcare professionals from an academic hospital that is seen as a leader in terms of its clinical governance expertise in the Netherlands. Main outcome measures Rated importance of each element on a four-point scale. Results The 50 elements that the panel perceived as most important related to adopting a bottom-up approach to clinical governance, ownership, teamwork, learning from mistakes and feedback. The panel did not reach a consensus concerning elements that referred to patient involvement. Elements that referred to a managerial approach to clinical governance and standardisation of work were rejected by the panel. Conclusions In the views of the panel of experts, clinical governance is a practice-based, value-driven approach that has the goal of delivering the highest possible quality care and ensuring the safety of patients. Bottom-up approaches and effective teamwork are seen as crucial for high quality and safe healthcare. Striving for high quality and safe healthcare is underpinned by continuous learning, shared responsibility and good relationships and collaboration between healthcare professionals, managers and patients. PMID:28082364

  18. FTD and ALS--translating mouse studies into clinical trials.

    PubMed

    Ittner, Lars M; Halliday, Glenda M; Kril, Jillian J; Götz, Jürgen; Hodges, John R; Kiernan, Matthew C

    2015-06-01

    Frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS) are related neurodegenerative disorders, which are characterized by a rapid decline in cognitive and motor functions, and short survival. Although the clinical and neuropathological characterization of these diseases has progressed--in part--through animal studies of pathogenetic mechanisms, the translation of findings from rodent models to clinical practice has generally not been successful. This article discusses the gap between preclinical animal studies in mice and clinical trials in patients with FTD or ALS. We outline how to better design preclinical studies, and present strategies to improve mouse models to overcome the translational shortfall. This new approach could help identify drugs that are more likely to achieve a therapeutic benefit for patients.

  19. Indices to assess patients with systemic lupus erythematosus in clinical trials, long-term observational studies, and clinical care.

    PubMed

    Castrejón, I; Tani, C; Jolly, M; Huang, A; Mosca, M

    2014-01-01

    This review summarises most currently used indices to assess and monitor patients with systemic lupus erythematosus (SLE) in clinical trials, long-term observational studies, and clinical care. Six SLE disease activity indices include the British Isles Lupus Assessment Group Index (BILAG), European Consensus Lupus Activity Measurement (ECLAM), Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Lupus Activity Index (LAI), and Systemic Lupus Erythematosus Activity Questionnaire (SLAQ). Three SLE responder indices include Responder Index for Lupus Erythematosus (RIFLE), SLE Responder Index (SRI), and BILAG Based Combined Lupus Assessment (BICLA). Three SLE damage indices include the Systemic Lupus International Collaborating Clinics/American College of Rheumatology-Damage Index (SLICC/ACE-DI), Lupus Damage Index Questionnaire (LDIQ), and Brief Index of Lupus Damage (BILD). The SLAQ, LDIQ and the BILD are patient self-report questionnaires, which appear to give similar information to physician-completed indices, but are pragmatically more easily completed as patients do almost all the work. Additional self-report indices which have been used to assess and monitor patients with in SLE include a generic general health short form 36 (SF36), a SLE-specific Lupus Patient Reported Outcome (LupusPRO), and a generic rheumatology index, Routine Assessment of Patient Index Data 3 (RAPID3). These activity, response, damage and patient self-report indices have been validated at different levels with no consensus about what it is the most appropriate for every setting. Sensitive and feasible assessment of SLE in clinical trials, observational studies, and busy clinical settings remains a challenge to the rheumatology community.

  20. Additional notes on clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance.

    PubMed

    Takaai, Mari; Kayano, Yuichiro; Shimizu, Takako; Taguchi, Masato; Hashimoto, Yukiya

    2008-01-01

    In the previous study, we performed a simulation of a clinical pharmacokinetic trial, in which blood was sampled at two time points corresponding to the peak concentration (C(peak)) and trough concentration (C(trough)) following repetitive oral administration at the dose, D, and dosing interval, tau. The approximate oral clearance (CL/F(approx)), estimated as 2 x D/(C(peak) x tau+C(trough) x tau), is accurate for drugs with an elimination half-life comparative to or longer than tau; however, it was suggested that we might not use CL/F(approx) for drugs with a considerably short elimination half-life relative to tau. In the present study, we evaluated the accuracy of the alternative oral clearance (CL/F(exp)) estimated by the simple monoexponential model. In contrast to CL/F(approx), CL/F(exp) was accurate for drugs with a short elimination half-life relative to tau. The present finding in conjunction with our previous study suggested that the peak-and-trough sampling design is promising for the clinical repeated-dose pharmacokinetic trial for drugs with not only slow but also rapid elimination from the body. We think that the accuracy and precision of the two analysis methods to estimate oral clearance (CL/F(approx) and CL/F(exp)) for a target drug should be evaluated carefully before and after a real clinical trial.

  1. Topics in Study Design and Analysis for Multistage Clinical Proteomics Studies.

    PubMed

    Zeng, Irene Sui Lan

    2016-01-01

    This chapter discusses the design issues in clinical proteomics study and provides specific suggestions for addressing these questions when using the standard guidelines for the planning. It provides two methods for the sample size estimation in study design. The first method is used for the planning of a clinical proteomic study at the discovery or verification stage; the second method is proposed for the systematic planning of a multistage study. The second part of the chapter introduces three approaches to analyzing the clinical proteomic study and provides analyses for two case studies of clinical proteomic discoveries.

  2. Computational study of the rate constants and free energies of intramolecular radical addition to substituted anilines

    PubMed Central

    Seddiqzai, Meriam; Dahmen, Tobias; Sure, Rebecca

    2013-01-01

    Summary The intramolecular radical addition to aniline derivatives was investigated by DFT calculations. The computational methods were benchmarked by comparing the calculated values of the rate constant for the 5-exo cyclization of the hexenyl radical with the experimental values. The dispersion-corrected PW6B95-D3 functional provided very good results with deviations for the free activation barrier compared to the experimental values of only about 0.5 kcal mol−1 and was therefore employed in further calculations. Corrections for intramolecular London dispersion and solvation effects in the quantum chemical treatment are essential to obtain consistent and accurate theoretical data. For the investigated radical addition reaction it turned out that the polarity of the molecules is important and that a combination of electrophilic radicals with preferably nucleophilic arenes results in the highest rate constants. This is opposite to the Minisci reaction where the radical acts as nucleophile and the arene as electrophile. The substitution at the N-atom of the aniline is crucial. Methyl substitution leads to slower addition than phenyl substitution. Carbamates as substituents are suitable only when the radical center is not too electrophilic. No correlations between free reaction barriers and energies (ΔG ‡ and ΔG R) are found. Addition reactions leading to indanes or dihydrobenzofurans are too slow to be useful synthetically. PMID:24062821

  3. Studies on the Food Additive Propyl Gallate: Synthesis, Structural Characterization, and Evaluation of the Antioxidant Activity

    ERIC Educational Resources Information Center

    Garrido, Jorge; Garrido, E. Manuela; Borges, Fernanda

    2012-01-01

    Antioxidants are additives largely used in industry for delaying, retarding, or preventing the development of oxidative deterioration. Propyl gallate (E310) is a phenolic antioxidant extensively used in the food, cosmetics, and pharmaceutical industries. A series of lab experiments have been developed to teach students about the importance and…

  4. Urokinase immobilized on medical polymeric materials: fundamental and clinical studies.

    PubMed

    Ohshiro, T; Kosaki, G

    1980-02-01

    One of the methods of preparing an antithrombogenic material is to immobilize a fibrinolytic enzyme on the surface of a carrier. The clinical trial of such a material must be subject to not only a basic study on the quality of a carrier, the technique of immobilization, and the method of disinfection, but also an in vivo study on its antithrombotic effect. Reported herein is the evaluation of the fibrinolytic ability, at fundamental and clinical levels, of the urokinase that was immobilized on the surface of various polymeric materials. The results were favorable.

  5. Musculoskeletal clinic in general practice: study of one year's referrals.

    PubMed Central

    Peters, D; Davies, P; Pietroni, P

    1994-01-01

    BACKGROUND. A musculoskeletal clinic, staffed by a general practitioner trained in osteopathy, medical acupuncture and intralesional injections, was set up in an inner London general practice in 1987. AIM. A retrospective study was undertaken of one year's referrals to the clinic in 1989-90 to determine how general practitioners were using the clinic in terms of problems referred; consultation patterns of patients attending the clinic and 12 months after initially being seen; and how access to the clinic influenced referrals to relevant hospital departments. METHOD. Day sheets were studied which recorded information on demographic characteristics of patients referred to the clinic and their problems, diagnoses made, duration of symptoms, number and range of treatments given, and recurrence of problems. Use of secondary referral sources was also examined. RESULTS. During the study year 154 of 3264 practice patients were referred to the musculoskeletal clinic, and attended a mean of 3.5 times each. Of all the attenders 64% were women and 52% were 30-54 years old. Eighty one patients (53%) presented with neck, back or sciatic pain. A specific traumatic, inflammatory or other pathological process could be ascribed to only 19% of patients. Regarding treatment, 88% of patients received osteopathic manual treatment or acupuncture, or a combination of these treatments and 4% received intralesional injections. Nine patients from the clinic (6%) were referred to an orthopaedic specialist during the year, two with acute back pain. Referrals to orthopaedic specialists by the practice as a whole were not significantly lower than the national average, although the practice made fewer referrals to physiotherapy and rheumatology departments than national figures would have predicted. Seventeen patients (11%) returned to the clinic with a recurrence of their main complaint within a year of their initial appointment; second courses of treatment were usually brief. CONCLUSION. The

  6. The recurrent PPP1CB mutation p.Pro49Arg in an additional Noonan-like syndrome individual: Broadening the clinical phenotype.

    PubMed

    Bertola, Débora; Yamamoto, Guilherme; Buscarilli, Michelle; Jorge, Alexander; Passos-Bueno, Maria Rita; Kim, Chong

    2017-03-01

    We report on a 12-year-old Brazilian boy with the p.Pro49Arg mutation in PPP1CB, a novel gene associated with RASopathies. This is the fifth individual described, and the fourth presenting the same variant, suggesting a mutational hotspot. Phenotypically, he also showed the same hair pattern-sparse, thin, and with slow growing-, similar to the typical ectodermal finding observed in Noonan syndrome-like disorder with loose anagen hair. Additionally, he presented craniosynostosis, a rare clinical finding in RASopathies. This report gives further support that this novel RASopathy-PPP1CB-related Noonan syndrome with loose anagen hair-shares great similarity to Noonan syndrome-like disorder with loose anagen hair, and expands the phenotypic spectrum by adding the cranial vault abnormality. © 2017 Wiley Periodicals, Inc.

  7. Communicating their individual results to participants in an environmental exposure study: Insights from clinical ethics

    SciTech Connect

    Deck, W.; Kosatsky, T. |

    1999-02-01

    A study measuring the uptake of chemical contaminants among sport fishers who consume fish caught in the St. Lawrence river is currently being conducted in Montreal, Canada. In this study, blood, hair, and urine collected from local sport fishers is being tested for heavy metals and persistent organochlorine chemicals. The objective of this study was to formulate a framework for determining what information to communicate to individual subjects of a study measuring biomarkers of exposure, consistent with the principles of ethical clinical and research practice. Methods consisted of review of the scope of environmental exposure studies, including the use of biomarker measurement in clinical medicine and environmental research and the relevant principles of clinical ethics and research practice. An exposure biomarker study is designed to elucidate constitutional, behavioral, and environmental determinants of tissue concentrations of exogenous substances. Ethical clinical and research practice, aiming to maximize autonomy and beneficence and to minimize harm, requires that study findings concerning the determinants of exposure be communicated to study participants. In addition, investigators should reference clinical action levels beyond which individual biomarker results are routinely communicated to participants. When biomarkers have no known relation to risk, or when levels fall below action levels, it may be preferable not co communicate individual results, if this arrangement has been formalized at the time of informed consent.

  8. Effectiveness of a diode laser in addition to non-surgical periodontal therapy: study of intervention

    PubMed Central

    Crispino, Antonio; Figliuzzi, Michele Mario; Iovane, Claudio; Del Giudice, Teresa; Lomanno, Simona; Pacifico, Delfina; Fortunato, Leonzio; Del Giudice, Roberto

    2015-01-01

    Summary Background Chronic periodontitis affects 47% of adult population over the age of 30. The first phase of periodontal treatment is always represented by scaling and root planning (SRP), that is a causal, non-surgical therapy that recognizes as primary aims the control of bacterial infection and the reduction of periodontal plaque-associated inflammation. Yet, another innovative causal therapy is represented by the irradiation of periodontal pockets with laser. Aim To evaluate the effect of a 940-nm diode laser as an adjunct to SRP in patients affected by periodontitis. Materials and methods Sixty-eight adult patients with moderate-to-severe periodontitis were sequentially enrolled and undergone to periodontal examination (V1) in order to detect gingival index (GI), plaque index (PI) and probing depth (PD). The patients were randomly divided into two groups: the first (n=34) received SRP treatment alone, the control group (n=34) received SRP and 940-nm diode laser therapy. Results Data were analyzed by Student’s t-test, with two tails; for all clinical parameters, both groups reported statistically significant differences compared to basal values (p<0.0001). Both procedures were effective in improving GI, PI and PD, but the use of diode laser was associated with more evident results. Conclusions Considered the better clinical outcomes, diode laser can be routinely associated with SRP in the treatment of periodontal pockets of patients with moderate-to-severe periodontitis. PMID:26161248

  9. SCORE study: quality indicators for rheumatology nursing clinics.

    PubMed

    Muñoz-Fernández, Santiago; Aguilar, Ma Dolores; Almodóvar, Raquel; Cano-García, Laura; Fortea, Sandra; Alcañiz-Escandell, Cristina Patricia; Rodríguez, José R; Cebrián, Laura; Lázaro, Pablo

    2017-03-01

    Nursing clinics in rheumatology (NCR) are organizational care models that provide care centred within the scope of nurses abilities. To analyse patients differences in the knowledge of the disease, adherence to the treatment, quality indicators of the Rheumatology Departments included quality perceived by the patients with and without NCR. National multicenter observational prospective cohort study 1 year follow-up, comparing patients attending rheumatology services with and without NCR. NCR was defined by the presence of: (1) office itself; (2) at least one dedicated nurse; (3) its own appointment schedule, and (4) phone. Variables included were (baseline and 12 months) Batalla, Haynes-Sackett, Morisky-Green and quality perceived tests. In addition, another specific questionnaire was drawn up to collect the healthcare, teaching and research activities of each Rheumatology Department. A total of 393 patients were included; 181 NCR and 212 not NCR, corresponding to 39 units, 21 with NCR and 18 without NCR (age 53 ± 11.8 vs 56 ± 13.5 years). Significant differences in favour of the NCR group were found in Haynes-Sackett (p = 0.033) and Morisky-Green (p = 0.03) tests in the basal visit. Significant differences were found in questions about "the courtesy and/or kindness received by the nurse", being "good or very good" in greater proportion in the NCR group. The publications from the last 5 years were significantly higher in the NCR group in both, national (p = 0.04) and international (p = 0.03) journals. A higher research activity and quality perceived by the patients are observed in the Rheumatology Departments with NCR.

  10. A laboratory study of the perceived benefit of additional noise attenuation by houses

    NASA Technical Reports Server (NTRS)

    Flindell, I. H.

    1983-01-01

    Two Experiments were conducted to investigate the perceived benefit of additional house attenuation against aircraft flyover noise. First, subjects made annoyance judgments in a simulated living room while an operative window with real and dummy storm windows was manipulated in full view of those subjects. Second, subjects made annoyance judgments in an anechoic audiometric test chamber of frequency shaped noise signals having spectra closely matched to those of the aircraft flyover noises reproduced in the first experiment. These stimuli represented the aircraft flyover noises in levels and spectra but without the situational and visual cues present in the simulated living room. Perceptual constancy theory implies that annoyance tends to remain constant despite reductions in noise level caused by additional attenuation of which the subjects are fully aware. This theory was supported when account was taken for a reported annoyance overestimation for certain spectra and for a simulated condition cue overreaction.

  11. A Search for Additional Planets in the Exoplanetary Systems Studied by the NASA EPOXI Mission

    NASA Astrophysics Data System (ADS)

    Ballard, Sarah; Christiansen, J. L.; Charbonneau, D.; Holman, M. J.; Deming, D.; Wellnitz, D. D.; A'Hearn, M. F.; EPOXI Team

    2010-01-01

    The EPOCh (Extrasolar Planet Observation and Characterization) component of the NASA EPOXI mission used the HRI camera aboard the Deep Impact spacecraft to observe transiting exoplanet systems from January through August 2008. The majority of these targets were each observed nearly continuously for several weeks at a time. We searched these high-precision time series for additional planets in these systems, which could be revealed either directly through their photometric transits, or indirectly through the variations these second planets induce on the times of transit of the previously known planet. We present upper limits on putative additional planets in six of the systems observed by EPOXI: HAT-P-4, TrES-3, GJ 436, TrES-2, WASP-3, and HAT-P-7.

  12. Thiopeptin, a New Feed-Additive Antibiotic: Biological Studies and Field Trials

    PubMed Central

    Mine, K.; Miyairi, N.; Takano, N.; Mori, S.; Watanabe, N.

    1972-01-01

    Thiopeptin is a new antibiotic, produced by Streptomyces tateyamensis and developed solely for animal use as a feed additive. The antibiotic content in animal tissue and feed was assayed in terms of the antimicrobial activity against Mycoplasma laidlawii A. This antibiotic was found to be relatively nontoxic in rats and mice. In chickens, this antibiotic is excreted into feces within 48 hr of administration and is not absorbed in tissue. It is well tolerated in both broilers and swine and is highly stable in animal feed. Thiopeptin-supplemented feed contributes to the improvement of weight gain, feed efficiency in chickens and swine, and the egg performance in layers. Thus, thiopeptin, when used as a feed additive, is quite suitable for supplementing animal nutrition. PMID:4680812

  13. Structural changes in gluten protein structure after addition of emulsifier. A Raman spectroscopy study

    NASA Astrophysics Data System (ADS)

    Ferrer, Evelina G.; Gómez, Analía V.; Añón, María C.; Puppo, María C.

    2011-06-01

    Food protein product, gluten protein, was chemically modified by varying levels of sodium stearoyl lactylate (SSL); and the extent of modifications (secondary and tertiary structures) of this protein was analyzed by using Raman spectroscopy. Analysis of the Amide I band showed an increase in its intensity mainly after the addition of the 0.25% of SSL to wheat flour to produced modified gluten protein, pointing the formation of a more ordered structure. Side chain vibrations also confirmed the observed changes.

  14. A Delphi Study of Additive Manufacturing Applicability for United States Air Force Civil Engineer Contingency Operations

    DTIC Science & Technology

    2015-03-26

    This simple process is the basis for most consumer-grade desktop AM machines, commonly known as 3D printers (Pham & Gault, 1998:1270). Material...as a single purchase to decrease initial capital costs. Once the 3D printers are purchased and delivered, the selected bases can begin training...for several Questions if you would liKe to explain or elaborate on your answers. Additional information •out 3D printers and UTCs is provided as an

  15. Clinical, scientific and ethnographic studies of influenza in quarantine.

    PubMed

    Oxford, John S; Oxford, Juliette R

    2012-08-01

    From the time of the Spanish influenza pandemic in 1918 to the present seclusion of volunteers in quarantine units, either modified hotels, Phase I units or specially constructed clinics, have been key in investigating new vaccines and antivirals. Carefully selected healthy, young volunteers undergo a 10-12-day sojourn under intense medical supervision. Clinical sampling includes nasal and throat washes for virus recovery, blood for clinical chemistry, analysis of B- and T-cell response and, more recently, analysis of human genes responding to infection. The authors' studies are resulting in new developments of universal influenza vaccines that could stimulate and prime CD4 and CD8 cells to shared epitopes in all influenza A viruses. Ethnographic study has noted an absence of quarantine stress in the volunteers for the first time.

  16. Magnetic Force Microscopy Study of Zr2Co11 -Based Nanocrystalline Materials: Effect of Mo Addition

    DOE PAGES

    Yue, Lanping; Jin, Yunlong; Zhang, Wenyong; ...

    2015-01-01

    Tmore » he addition of Molybdenum was used to modify the nanostructure and enhance coercivity of rare-earth-free Zr2Co11-based nanocrystalline permanent magnets. he effect of Mo addition on magnetic domain structures of melt spun nanocrystalline Zr16Co84-xMox(x=0, 0.5, 1, 1.5, and 2.0) ribbons has been investigated. It was found that magnetic properties and local domain structures are strongly influenced by Mo doping. he coercivity of the samples increases with the increase in Mo content (x≤1.5). he maximum energy product(BH)maxincreases with increasingxfrom 0.5 MGOe forx=0to a maximum value of 4.2 MGOe forx=1.5. he smallest domain size with a relatively short magnetic correlation length of 128 nm and largest root-mean-square phase shiftΦrmsvalue of 0.66° are observed for thex=1.5. he optimal Mo addition promotes magnetic domain structure refinement and thus leads to a significant increase in coercivity and energy product in this sample.« less

  17. Load bearing and stiffness tailored NiTi implants produced by additive manufacturing: a simulation study

    NASA Astrophysics Data System (ADS)

    Rahmanian, Rasool; Shayesteh Moghaddam, Narges; Haberland, Christoph; Dean, David; Miller, Michael; Elahinia, Mohammad

    2014-03-01

    Common metals for stable long-term implants (e.g. stainless steel, Titanium and Titanium alloys) are much stiffer than spongy cancellous and even stiffer than cortical bone. When bone and implant are loaded this stiffness mismatch results in stress shielding and as a consequence, degradation of surrounding bony structure can lead to disassociation of the implant. Due to its lower stiffness and high reversible deformability, which is associated with the superelastic behavior, NiTi is an attractive biomaterial for load bearing implants. However, the stiffness of austenitic Nitinol is closer to that of bone but still too high. Additive manufacturing provides, in addition to the fabrication of patient specific implants, the ability to solve the stiffness mismatch by adding engineered porosity to the implant. This in turn allows for the design of different stiffness profiles in one implant tailored to the physiological load conditions. This work covers a fundamental approach to bring this vision to reality. At first modeling of the mechanical behavior of different scaffold designs are presented as a proof of concept of stiffness tailoring. Based on these results different Nitinol scaffolds can be produced by additive manufacturing.

  18. Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials.

    PubMed

    Shirotani, Mari; Suwa, Toshio; Kurokawa, Tatsuo; Chiba, Koji

    2014-04-01

    The required number of Japanese subjects was compared between the Bridging (BG) filing strategy described in ICH-E5 for drugs approved from 1998 to 2012, in which foreign phase 3 results were used together with a BG study conducted to confirm optimum Japanese dose, and global clinical trial (GCT) strategies in which the number was simulated from the foreign phase 3 studies. The simulated number from the GCT strategy was smaller than that of the BG, suggesting that the GCT strategy could be expected to reduce Japanese clinical trial costs. However, two exceptions were found, namely for preventive drugs and drugs for children, because of the large scales of foreign phase 3 studies.

  19. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    PubMed Central

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  20. Factors affecting clinical reasoning of occupational therapists: a qualitative study

    PubMed Central

    Shafaroodi, Narges; Kamali, Mohammad; Parvizy, Soroor; Mehraban, Afsoon Hassani; O’Toole, Giyn

    2014-01-01

    Background: Clinical reasoning is generally defined as the numerous modes of thinking that guide clinical practice but little is known about the factors affecting how occupational therapists manage the decision-making process. The aim of this qualitative study was to explore the factors influencing the clinical reasoning of occupational therapists. Methods: Twelve occupational therapy practitioners working in mental and physical dysfunction fields participated in this study. The sampling method was purposeful and interviews were continued until data saturation. All the interviews were recorded and transcribed. The data were analyzed through a qualitative content analysis method. Results: There were three main themes. The first theme: socio-cultural conditions included three subthemes: 1- client beliefs; 2- therapist values and beliefs; 3- social attitude to disability. The second theme: individual attributions included two subthemes 1- client attributions; 2- therapist attributions. The final theme was the workplace environment with the three subthemes: 1- knowledge of the managers of rehabilitation services, 2- working in an inter-professional team; 3- limited clinical facilities and resources. Conclusion: In this study, the influence of the attitudes and beliefs of client, therapist and society about illness, abilities and disabilities upon reasoning was different to previous studies. Understanding these factors, especially the socio-cultural beliefs basis can play a significant role in the quality of occupational therapy services. Accurate understanding of these influential factors requires more extensive qualitative and quantitative studies. PMID:25250253

  1. Influence of Study Design Variables on Clinical Pathology Data.

    PubMed

    Aulbach, Adam; Provencher, Anne; Tripathi, Niraj

    2017-02-01

    A number of factors related to study design have the potential to impact clinical pathology test results during the conduct of nonclinical safety studies. A thorough understanding of these factors is paramount in drawing accurate conclusions from clinical pathology data generated during such studies, particularly when attempting to make the distinction between test article and nontest article-related effects. Study design and conduct variables with potential to impact clinical pathology data discussed in this overview include those related to species and test system, animal age, animal care and husbandry practices, fasting, acclimatization periods, effects of transportation and stressors, route of administration, effects of in-life and surgical procedures, influence of study length, timing of blood collections, impact of vehicle/formulation composition, and some general concepts related to drug class. The material presented here is a summary based on information presented at the 35th Annual Symposium of the Society of Toxicologic Pathology (June 2016), during Symposium Session 2 titled "Deciphering Sources of Variability in Clinical Pathology-It's Not Just about the Numbers."

  2. Effect of Ozonised water on Chronic Periodontitis - A Clinical Study

    PubMed Central

    Katti, Sandeep S; Chava, Vijay Kumar

    2013-01-01

    Background: The aim of the study was to study the clinical effects of ozonated water on periodontal tissues. Materials & Methods: In the present study 30 subjects were selected with age ranging from 20 to 60 yearsand pocket depth of ≥5mm. Two sites were selected in each patient whichwere divided into two groups. Group 1(control group-irrigation with saline) and Group 2(study group-irrigation with ozonized water) and clinical parameters were recorded at baseline, 15 days and 30 days. Results: When the comparison of mean values of Plaque Index and Gingival Index between the groups and at different time intervals were made, statistically significant difference were observed at 30 days at 5% level. When the mean values of clinical attachment level on mesial and distal site was compared between the groups, statistical significance was observed at 5% level and 1% level respectively.Similarly statistical significance at 5% level was observed at 15 and 30 days on buccal site. Conclusion: Subgingival irrigation with ozonized water is beneficial adjunct treatment modality to enhance periodontal health with significant role in periodontal therapy. How to cite this article: Katti SS, Chava VK. Effect of Ozonised water on Chronic Periodontitis - A Clinical Study. J Int Oral Health 2013;5(5):79-84. PMID:24324309

  3. Comparative clinical pharmacokinetics of antibody-drug conjugates in first-in-human Phase 1 studies

    PubMed Central

    Deslandes, Antoine

    2014-01-01

    Although there are currently more than 30 antibody-drug conjugates (ADC) in clinical development for the treatment of blood cancers and solid tumors, comparison of their clinical pharmacokinetics (PK) is challenging because of the large number of, and differences between, the targets, ADC constructs, dosing regimens, and patient populations. In this review, we standardized the evaluation, using non-compartmental PK data reported at Cycle 1, i.e., following the first drug administration of what is usually a repeated-dose treatment, in monotherapy. We report ADC clinical PK properties, dosing regimen, determination of doses ranges and associated maximum tolerated doses. We also evaluated the effect of structural characteristics and target types (hematological vs. solid tumors) on PK. In addition, we discuss how integration of PK/pharmacodynamics approaches on top of classical dose escalation in first-in-human studies may improve dosing regimen determination for subsequent phases of clinical development. PMID:24852950

  4. Participants’ perception of pharmaceutical clinical research: a cross-sectional controlled study

    PubMed Central

    González-Saldivar, Gerardo; Rodríguez-Gutiérrez, René; Viramontes-Madrid, José Luis; Salcido-Montenegro, Alejandro; Carlos-Reyna, Kevin Erick Gabriel; Treviño-Alvarez, Andrés Marcelo; Álvarez-Villalobos, Neri Alejandro; González-González, José Gerardo

    2016-01-01

    Background There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials. Methods To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico. Results Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again. Conclusion Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions. PMID:27199549

  5. Study of the structure of steel 12Kh12M1BFP modified with additions of fullerenes and carbon nanotubes

    NASA Astrophysics Data System (ADS)

    Glebov, V. A.; Bakulina, A. S.; Efremov, I. V.; Shchetinin, I. V.; Yagodkin, Yu. D.; Glezer, A. M.; Rashkovskii, A. Yu.; Vainshtein, D. L.

    2010-12-01

    X-ray structural analysis, scanning electron microscopy, x-ray photoelectron spectroscopy, atomic force microscopy are used to study the structure of compacted specimens of steel 12Kh12M1BFP, modified with additions of fullerenes and carbon nanotubes. The effect of additions on the microhardness of compacted specimens is established.

  6. Interdepartmental graduate studies in clinical pharmacology: a practical model.

    PubMed

    Jallad, N S

    1994-11-01

    The discipline of Clinical Pharmacology serves many purposes and plays a critical role in therapeutic education, especially in a medical school. An effective program bridges the gap between basic pharmacology and clinical practice. A clinical pharmacology program must provide the student with the necessary information to employ the basic pharmacology knowledge gained in formatting a successful therapeutic plan. The program is built around the student and brings together the best to be offered in 2 or more disciplines; it requires diverse disciplines to work together in a variety of departments and centers which cut across disciplinary lines. In order to facilitate this interaction, the Division of Clinical Pharmacology at the University of Miami embarked on establishing a Ph.D. program with an emphasis on Clinical Pharmacology utilizing an already established unique program referred to as "Interdepartmental Graduate Studies". To enter the structured Ph.D. program the students must be among the fellowship awardees of the Interdepartment Graduate Studies Program, which is administered by social committees with specific roles, directions and guidelines. The students follow the general requirements of the Ph.D. degree set forth by the graduate school. Students attend formal classes tailored to their program of interest based on the committee's recommendations in the respective departments involved. The significance of this program is that it can be tailored to fit individual areas of interest leading to a well-developed researcher who is neither overspecialized nor undereducated and able to make rational decisions in an age of multiple therapies.

  7. Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes

    PubMed Central

    Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho; Ogata, Hiraku; Tatsukawa, Seishiro; Yin, Guang; Okada, Rieko; Morita, Emi; Naito, Mariko; Tokumasu, Atsumi; Onoue, Hiroyuki; Iwaya, Keiichi; Ito, Toshimitsu; Takada, Tappei; Inoue, Katsuhisa; Kato, Yukio; Nakamura, Yukio; Sakurai, Yutaka; Suzuki, Hiroshi; Kanai, Yoshikatsu; Hosoya, Tatsuo; Hamajima, Nobuyuki; Inoue, Ituro; Kubo, Michiaki; Ichida, Kimiyoshi; Ooyama, Hiroshi; Shimizu, Toru; Shinomiya, Nariyoshi

    2016-01-01

    Objective Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. Methods A GWAS was conducted with 945 patients with clinically defined gout and 1213 controls in a Japanese male population, followed by replication study of 1048 clinically defined cases and 1334 controls. Results Five gout susceptibility loci were identified at the genome-wide significance level (p<5.0×10−8), which contained well-known urate transporter genes (ABCG2 and SLC2A9) and additional genes: rs1260326 (p=1.9×10−12; OR=1.36) of GCKR (a gene for glucose and lipid metabolism), rs2188380 (p=1.6×10−23; OR=1.75) of MYL2-CUX2 (genes associated with cholesterol and diabetes mellitus) and rs4073582 (p=6.4×10−9; OR=1.66) of CNIH-2 (a gene for regulation of glutamate signalling). The latter two are identified as novel gout loci. Furthermore, among the identified single-nucleotide polymorphisms (SNPs), we demonstrated that the SNPs of ABCG2 and SLC2A9 were differentially associated with types of gout and clinical parameters underlying specific subtypes (renal underexcretion type and renal overload type). The effect of the risk allele of each SNP on clinical parameters showed significant linear relationships with the ratio of the case–control ORs for two distinct types of gout (r=0.96 [p=4.8×10−4] for urate clearance and r=0.96 [p=5.0×10−4] for urinary urate excretion). Conclusions Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. PMID:25646370

  8. Strategic Petroleum Reserve (SPR) additional geologic site characterization studies, Bryan Mound Salt Dome, Texas

    SciTech Connect

    Neal, J.T.; Magorian, T.R.; Ahmad, S.

    1994-11-01

    This report revises the original report that was published in 1980. Some of the topics covered in the earlier report were provisional and it is now practicable to reexamine them using new or revised geotechnical data and that obtained from SPR cavern operations, which involves 16 new caverns. Revised structure maps and sections show interpretative differences as compared with the 1980 report and more definition in the dome shape and caprock structural contours, especially a major southeast-northwest trending anomalous zone. The original interpretation was of westward tilt of the dome, this revision shows a tilt to the southeast, consistent with other gravity and seismic data. This interpretation refines the evaluation of additional cavern space, by adding more salt buffer and allowing several more caverns. Additional storage space is constrained on this nearly full dome because of low-lying peripheral wetlands, but 60 MMBBL or more of additional volume could be gained in six or more new caverns. Subsidence values at Bryan Mound are among the lowest in the SPR system, averaging about 11 mm/yr (0.4 in/yr), but measurement and interpretation issues persist, as observed values are about the same as survey measurement accuracy. Periodic flooding is a continuing threat because of the coastal proximity and because peripheral portions of the site are at elevations less than 15 ft. This threat may increase slightly as future subsidence lowers the surface, but the amount is apt to be small. Caprock integrity may be affected by structural features, especially the faulting associated with anomalous zones. Injection wells have not been used extensively at Bryan Mound, but could be a practicable solution to future brine disposal needs. Environmental issues center on the areas of low elevation that are below 15 feet above mean sea level: the coastal proximity and lowland environment combined with the potential for flooding create conditions that require continuing surveillance.

  9. Additive value of blood neutrophil gelatinase-associated lipocalin to clinical judgement in acute kidney injury diagnosis and mortality prediction in patients hospitalized from the emergency department

    PubMed Central

    2013-01-01

    Introduction Acute kidney injury (AKI) is a common complication among hospitalized patients. The aim of this study was to evaluate the utility of blood neutrophil gelatinase-associated lipocalin (NGAL) assessment as an aid in the early risk evaluation for AKI development in admitted patients. Methods This is a multicenter Italian prospective emergency department (ED) cohort study in which we enrolled 665 patients admitted to hospital from the ED. Results Blood NGAL and serum creatinine (sCr) were determined at ED presentation (T0), and at: 6 (T6), 12 (T12), 24 (T24) and 72 (T72) hours after hospitalization. A preliminary assessment of AKI by the treating ED physician occurred in 218 out of 665 patients (33%), while RIFLE AKI by expert nephrologists was confirmed in 49 out of 665 patients (7%). The ED physician's initial judgement lacked sensitivity and specificity, overpredicting the diagnosis of AKI in 27% of the cohort, while missing 20% of those with AKI as a final diagnosis. The area under the receiver operating characteristic curve (AUC), obtained at T0, for blood NGAL alone in the AKI group was 0.80. When NGAL at T0 was added to the ED physician's initial clinical judgment the AUC was increased to 0.90, significantly greater when compared to the AUC of the T0 estimated glomerular filtration rate (eGFR) obtained either by modification of diet in renal disease (MDRD) equation (0.78) or Cockroft-Gault formula (0.78) (P = 0.022 and P = 0.020 respectively). The model obtained by combining NGAL with the ED physician's initial clinical judgement compared to the model combining sCr with the ED physician's initial clinical judgement, resulted in a net reclassification index of 32.4 percentage points. Serial assessment of T0 and T6 hours NGAL provided a high negative predictive value (NPV) (98%) in ruling out the diagnosis of AKI within 6 hours of patients' ED arrival. NGAL (T0) showed the strongest predictive value for in-hospital patient's mortality at a cutoff of

  10. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies.

    PubMed

    Noorkõiv, Marika; Rodgers, Helen; Price, Christopher I

    2014-10-09

    The aim of this review was to identify and summarise publications, which have reported clinical applications of upper limb accelerometry for stroke within free-living environments and make recommendations for future studies. Data was searched from MEDLINE, Scopus, IEEExplore and Compendex databases. The final search was 31st October 2013. Any study was included which reported clinical assessments in parallel with accelerometry in a free-living hospital or home setting. Study quality is reflected by participant numbers, methodological approach, technical details of the equipment used, blinding of clinical measures, whether safety and compliance data was collected. First author screened articles for inclusion and inclusion of full text articles and data extraction was confirmed by the third author. Out of 1375 initial abstracts, 8 articles were included. All participants were stroke patients. Accelerometers were worn for either 24 hours or 3 days. Data were collected as summed acceleration counts over a specified time or as the duration of active/inactive periods. Activity in both arms was reported by all studies and the ratio of impaired to unimpaired arm activity was calculated in six studies. The correlation between clinical assessments and accelerometry was tested in five studies and significant correlations were found. The efficacy of a rehabilitation intervention was assessed using accelerometry by three studies: in two studies both accelerometry and clinical test scores detected a post-treatment difference but in one study accelerometry data did not change despite clinical test scores showing motor and functional improvements. Further research is needed to understand the additional value of accelerometry as a measure of upper limb use and function in a clinical context. A simple and easily interpretable accelerometry approach is required.

  11. Second Mesiobuccal Canal Treatment in a Predoctoral Dental Clinic: A Retrospective Clinical Study.

    PubMed

    Coelho, Marcelo Santos; Parker, Jeffrey M; Tawil, Peter Z

    2016-06-01

    The aim of this retrospective clinical study was to evaluate the location and treatment of second canals in mesiobuccal roots (MB2) of first and second maxillary molars in a predoctoral endodontic clinic by the graduating classes of 2008 to 2015. These results were compared to similar clinical studies. Included in the study were 368 root canal treatments performed by 310 third- and fourth-year dental students at one U.S. dental school. All cases were done under faculty supervision, and the students were instructed to use dental loupe magnification. Students' evaluation sheets were used to deteremine the total MB2 canals treated in first and second maxillary molars. The results showed that, overall, 72.55% of the teeth had an MB2 canal treated. The frequency was higher in first molars (75.91%) than in second molars (56.92%) (p<0.05). Third-year students were able to detect 39 MB2 canals in 57 maxillary molars (68.42%), while fourth-year students detected 228 MB2 canals in 311 teeth (73.31%) (p>0.05). Under proper supervision by experienced endodontists, these dental students were capable of treating MB2 canals in maxillary molars. The frequency of MB2 canals located and treated by dental students with the assistance of experienced professionals was higher in first than in second molars. No significant difference was found between third- and fourth-year students. The incidence of MB2 canals located and treated in this study was found to be similar to that in other clinical studies.

  12. Quantitative assessment of the benefits of specific information technologies applied to clinical studies in developing countries.

    PubMed

    Avilés, William; Ortega, Oscar; Kuan, Guillermina; Coloma, Josefina; Harris, Eva

    2008-02-01

    Clinical studies and trials require accessibility of large amounts of high-quality information in a timely manner, often daily. The integrated application of information technologies can greatly improve quality control as well as facilitate compliance with established standards such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). We have customized and implemented a number of information technologies, such as personal data assistants (PDAs), geographic information system (GIS), and barcode and fingerprint scanning, to streamline a pediatric dengue cohort study in Managua, Nicaragua. Quantitative data was obtained to assess the actual contribution of each technology in relation to processing time, accuracy, real-time access to data, savings in consumable materials, and time to proficiency in training sessions. In addition to specific advantages, these information technologies benefited not only the study itself but numerous routine clinical and laboratory processes in the health center and laboratories of the Nicaraguan Ministry of Health.

  13. Experiencing Virtual Patients in Clinical Learning: A Phenomenological Study

    ERIC Educational Resources Information Center

    Edelbring, Samuel; Dastmalchi, Maryam; Hult, Hakan; Lundberg, Ingrid E.; Dahlgren, Lars Owe

    2011-01-01

    Computerised virtual patients (VPs) are increasingly being used in medical education. With more use of this technology, there is a need to increase the knowledge of students' experiences with VPs. The aim of the study was to elicit the nature of virtual patients in a clinical setting, taking the students' experience as a point of departure.…

  14. Statistical aspect of translational and correlative studies in clinical trials

    PubMed Central

    Pang, Herbert; Wang, Xiaofei

    2015-01-01

    In this article, we describe statistical issues related to the conduct of translational and correlative studies in cancer clinical trials. In the era of personalized medicine, proper biomarker discovery and validation is crucial for producing groundbreaking research. In order to carry out the framework outlined in this article, a team effort between oncologists and statisticians is the key for success. PMID:26932435

  15. Simulation and the Development of Clinical Judgment: A Quantitative Study

    ERIC Educational Resources Information Center

    Holland, Susan

    2015-01-01

    The purpose of this quantitative pretest posttest quasi-experimental research study was to explore the effect of the NESD on clinical judgment in associate degree nursing students and compare the differences between groups when the Nursing Education Simulation Design (NESD) guided simulation in order to identify educational strategies promoting…

  16. Sports Medicine. Clinical Rotation. Instructor's Packet and Student Study Packet.

    ERIC Educational Resources Information Center

    Texas Univ., Austin. Extension Instruction and Materials Center.

    The materials in this packet are for a course designed to provide individualized classroom study for a specific area of clinical rotation--sports medicine. The instructor's manual describes the learning objectives together with a list of reference materials that should be provided for completion of the student worksheets, and lists suggested…

  17. Oncolytic Virus: Regulatory Aspects from Quality Control to Clinical Studies.

    PubMed

    Yamaguchi, Teruhide; Uchida, Eriko

    2017-02-22

    Oncolytic viruses, which include both naturally occurring wild-type viruses/attenuated viruses and genetically modified viruses, have recently been developed for use in innovative cancer therapies. Genetically modified oncolytic viruses possess the unique ability to replicate conditionally as a unique gene therapy product. Since oncolytic viruses exhibit prolonged persistence in patients, viral shedding and transmission to third parties should be major concerns for clinical trials, along with the clinical safety and efficacy. Accordingly, studies are now underway to establish the safety and efficacy of oncolytic viruses.

  18. Analgesia in Amphibians: Preclinical Studies and Clinical Applications

    PubMed Central

    Stevens, Craig W.

    2010-01-01

    SYNOPSIS Preclinical studies of analgesia in amphibians or recommendations for clinical use of analgesics in amphibian species are extremely limited. This article briefly reviews the issues surrounding the use of analgesics in amphibians starting with common definitions of pain and analgesia when applied to non-human animals. Nociceptive and endogenous opioid systems in amphibians are reviewed and results of preclinical research on opioid and non-opioid analgesics summarized. Recommended opioid and non-opioid analgesics are summarized and practical recommendations made for their clinical use. PMID:21074701

  19. [Clinical studies with cefmenoxime in the field of pediatrics].

    PubMed

    Takimoto, M; Yoshioka, H; Maruyama, S; Sanae, N; Nagamatsu, I

    1982-10-01

    The present study was performed to evaluate the clinical effectiveness and safety of cefmenoxime (CMX), a new cephalosporin antibiotic for injection in the field of pediatrics. Thirty-one cases, including 2 cases with sepsis, 18 cases with respiratory tract infections and 7 cases with urinary tract infections, were given CMX at daily doses of 30 mg/kg to 125 mg/kg divided into 3 or 4 for 3 days to 13 days. Clinical responses were excellent in 16 cases, good in 9 cases and poor in 6 cases, the satisfactory response being 80.6%. No side effects and no abnormal laboratory findings relating to the drug were observed.

  20. Exploring Factors Affecting Undergraduate Medical Students' Study Strategies in the Clinical Years: A Qualitative Study

    ERIC Educational Resources Information Center

    Al Kadri, Hanan M. F.; Al-Moamary, Mohamed S.; Elzubair, Margaret; Magzoub, Mohi Eldien; AlMutairi, Abdulrahman; Roberts, Christopher; van der Vleuten, Cees

    2011-01-01

    The aim of this study is to explore the effects of clinical supervision, and assessment characteristics on the study strategies used by undergraduate medical students during their clinical rotations. We conducted a qualitative phenomenological study at King Saud Bin Abdulaziz University for Health Sciences, College of Medicine, Riyadh, Saudi…

  1. [Key technologies elements of clinical study of traditional Chinese medicine new drugs on children's dermatitis and eczema].

    PubMed

    Zhong, Cheng-Liang; Zhang, Chun; Hu, Si-Yuan

    2013-06-01

    We assessed and graded the evidence of relevant systematic reviews and randomized controlled trials, combined with our clinical study practice to identify eleven key elements as a focus for the clinical study of traditional Chinese medicine (TCM) new drugs on children's dermatitis and eczema: the primary purpose and design of the study, the inclusion and exclusion criteria of the study, the treatment, the trail procedure,the effectiveness and safety evaluation, and quality control, etc, as well. In addition, seven recommendations for the design of clinical study of TCM new drugs on children's dermatitis and eczema were provided.

  2. Clinical outcome of gliosarcoma compared with glioblastoma multiforme: a clinical study in Chinese patients.

    PubMed

    Zhang, Guobin; Huang, Shengyue; Zhang, Junting; Wu, Zhen; Lin, Song; Wang, Yonggang

    2016-04-01

    Gliosarcoma (GSM) is a rare biphasic neoplasms of the central nervous system composed of a glioblastoma multiforme (GBM) admixed with a sarcomatous component. In clinical practice GSM is generally managed similarly to GBM. However, there are conflicting reports regarding their clinical aggressiveness, cell line of origin and possible prognosis compared with those of GBM. The objective of this study was to compare clinic-pathological features in GSM patients with the GBM patients during the same study period. 518 patients with GBM were treated at our hospital between 2008 and 2013, among them 51 were GSM. In this series the GSMs represented 9.8% of all GBMs and included 58.8% male with a median age of 44.7 years. The locations, all supratentorial, included temporal in 41.2%, frontal in 25.5%, parietal in 19.6%, and occipital in 13.7%. All patients underwent tumor resection followed by post-operative radiation and adjuvant chemotherapy. The O6-methylguanine-DNA methyltransferase promoter methylation studies were significantly more frequent in the GBMs than GSMs (80.1% vs. 44.7%, P < 0.001). The median progression free survival and overall survival for the patients with GSM were 8.0 and 13.0 months, respectively, as compared with 9.0 and 14.0 months in the GBM group (log rank test P = 0.001 and 0.004, respectively). The Cox proportional hazards regression model indicated that the extent of tumor resection (HR = 1.518, P = 0.009) and pathological types (HR = 0.608, P = 0.002) were the significant prognostic factors in our own series. With regard to clinical features and outcomes, GSM and GBM cannot be distinguished clinically. GSM in China may be managed similarly to GBM, with maximal safe surgical resection followed by chemo-radiotherapy. Our study adds further evidence to support GSM as a unique clinical entity with a likely worse prognosis than GBM.

  3. The use of clinical logs to improve nursing students' metacognition: a pilot study.

    PubMed

    Fonteyn, M E; Cahill, M

    1998-07-01

    The purpose of this study was to examine the effectiveness of the use of a reflective clinical log to improve students' thinking strategies and metacognition (cognitive awareness). Rather than prepare a written nursing care plan prior to entering the clinical setting, students instead were asked to write in a clinical log at the completion of their clinical day, reflecting upon client problems that they had identified, the data that were used to identify these problems, the nursing interventions that were used, and the results of these interventions. The students reported that they preferred the use of a reflective log over writing nursing care plans and they felt that the logs improved their ability to think about their thinking (i.e. their metacognition). The results of this pilot study indicate that reflection in clinical logs assists students to become more active learners, to manage their own thinking, and to improve their metacognition. Additional research in this area is needed to confirm study findings and to provide further understanding regarding the effectiveness of clinical logs as a teaching strategy to improve students' metacognition.

  4. A Review of Approaches to the Study of Turbulence Modification by Means of Non-Newtonian Additives

    DTIC Science & Technology

    1987-12-10

    interesting class of polymers for drag reduction studies. These polymers ( xanthomonas campestris , guar gum) were found to show long term stability...and their superiority to "typical" drag reducing polymers like polyethylene oxide, was evident. His degradation studies showed that the xanthomonas ... campestris is a better and more durable additive than guar gum. One of the most important biological additives is the DNA. It is actually a random

  5. [Study and prospects for clinical diseases treated with scraping therapy].

    PubMed

    Wang, Ying-ying; Yang, Jin-sheng

    2009-02-01

    In order to explore characteristics of clinical diseases treated by scraping therapy, summarize laws of clinical application of scraping therapy, and prospect for research direction of scraping therapy in future, collect 437 articles about scraping therapy between 1994-2007 and analyze and summarize the treated diseases and methods of scraping therapy. Results indicate that scraping therapy has been widely applied to commonly encountered diseases and frequently encountered diseases in departments of internal medicine, surgery, gynecology and pediatrics, etc. with more obvious therapeutic effects. Clinically, it can combine with acupuncture and moxibustion, cupping, massage, blood-letting puncture and other methods. In future, the studies on standardization of manipulation and standards for assessment of therapeutic effect, suitable diseases and the mechanisms of scraping therapy, and development of tools and media, etc. of scraping therapy should be strengthened.

  6. The SAPHO syndrome: a clinical and imaging study.

    PubMed

    Sallés, Meritxell; Olivé, Alejandro; Perez-Andres, Ricard; Holgado, Susana; Mateo, Lourdes; Riera, Elena; Tena, Xavier

    2011-02-01

    The purpose of this study is to describe the clinical and radiological manifestations of patients with the synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome. Retrospective study (1984-2007) was performed in a single center. All patients with the SAPHO syndrome were included. Fifty-two patients were included: 26 male, mean age at diagnosis is 42±12 years. Ostearticular involvement was present before cutaneous involvement in 59.6% of patients and concomitantly in 23.5%. Anterior chest pain was the commonest clinical manifestation, it was present in 38 patients (73%), followed by peripheral arthritis in 17 patients (32%), and sacroliliac pain in 14 patients (26.9%). Cutaneous involvement was present in 33 patients (63.5%). HLA B27 antigen was present in eight patients (17.7%). Bone scintigraphy showed an increased uptake in 42 patients (93.3%). The location of the uptake was mainly in sternoclavicular and manubriosternal joints. CT scan was performed in all "hot joints" showing sclerosis, erosions, hyperostosis, and soft tissue involvement. Refractory patients were treated mainly with pamidronate. Although SAPHO syndrome is an entity that share features that fit into a variety of established disease categories, the present study has a homogenous clinical and radiological pattern that gives support to believe that the SAPHO syndrome is an isolated clinical entity.

  7. Parasitological and clinical studies on human scabies in Cairo.

    PubMed

    Sarwat, M A; el Okbi, L M; el Sayed, M M; el Okbi, S M; el Deeb, H K

    1993-12-01

    This study is a parasitological and clinical study on human scabies. This study was carried out on 100 patients attending the Dermatology Outpatient Clinic at Ain Shams University Hospitals, including 54 males and 46 females. All patients were subjected to detailed history taking, complete dermatological examination including Skin Scraping Test and Burrow Ink Test. Younger patients attended the dermatology clinic earlier than older patients, who usually delayed their visits until complications occurred. Scratching, erythematous papules and secondary infected lesions were the commonest lesions. The hands, wrist and external genitalia were the most frequently affected sites while the feet, ankles, knees and back were the least affected. Burrows could only be detected in 40% of patients. The most frequent sites were the web spaces, external genitalia, and finger sides. Burrow Ink Test was positive among 85% of patients with burrows while mites could be identified by Skin Scraping Test in 55% of patients. The most frequent clinical manifestations in the parasitologically positive patients were itching, burrows, and papules, and the most frequent sites were the web spaces, and the finger sides. Multiple sites affection was the characteristic feature among the preschool age children who represented 14% of cases.

  8. HDL and Atherosclerosis Regression: Evidence from Pre-clinical and Clinical Studies

    PubMed Central

    Feig, Jonathan E.; Hewing, Bernd; Smith, Jonathan D.; Hazen, Stanley L.; Fisher, Edward A.

    2014-01-01

    High density lipoprotein particles (HDL) transport, among other molecules, cholesterol (HDL-C). In epidemiologic studies, plasma HDL-C levels have an inverse relationship to the risk of atherosclerotic cardiovascular disease (CVD). It has been assumed that this reflects the protective functions of HDL, which include their ability to promote cholesterol efflux. Yet, a number of recent pharmacological and genetic studies have failed to demonstrate that increased plasma levels of HDL-C resulted in decreased CVD risk, giving rise to a controversy over whether plasma levels of HDL-C reflect HDL function, or that HDL is even as protective as assumed. On balance, the evidence from pre-clinical and (limited) clinical studies show that HDL can promote the regression of atherosclerosis when the levels of functional particles are increased from endogenous or exogenous sources. The data show that regression results from a combination of reduced plaque lipid and macrophage contents, as well as from a reduction in its inflammatory state. While more research will be needed on basic mechanisms and to establish that these changes translate clinically to reduced CVD events, that HDL can regress plaques suggests that the recent trial failures do not eliminate HDL from consideration as an atheroprotective agent, but emphasizes the important distinction between HDL function and plasma levels of HDL-C. PMID:24385513

  9. A pilot-scale study of selective desulfurization via urea addition in iron ore sintering

    NASA Astrophysics Data System (ADS)

    Long, Hong-ming; Wu, Xue-jian; Chun, Tie-jun; Di, Zhan-xia; Wang, Ping; Meng, Qing-min

    2016-11-01

    The iron ore sintering process is the main source of SO2 emissions in the iron and steel industry. In our previous research, we proposed a novel technology for reducing SO2 emissions in the flue gas in the iron ore sintering process by adding urea at a given distance from the sintering grate bar. In this paper, a pilot-scale experiment was carried out in a commercial sintering plant. The results showed that, compared to the SO2 concentration in flue gas without urea addition, the SO2 concentration decreased substantially from 694.2 to 108.0 mg/m3 when 0.10wt% urea was added. NH3 decomposed by urea reacted with SO2 to produce (NH4)2SO4, decreasing the SO2 concentration in the flue gas.

  10. THERMODYNAMIC STUDY OF THE NICKEL ADDITION IN ZINC HOT-DIP GALVANIZING BATHS

    SciTech Connect

    Pistofidis, N.; Vourlias, G.

    2010-01-21

    A usual practice during zinc hot-dip galvanizing is the addition of nickel in the liquid zinc which is used to inhibit the Sandelin effect. Its action is due to the fact that the zeta(zeta) phase of the Fe-Zn system is replaced by the TAU(tau) phase of the Fe-Zn-Ni system. In the present work an attempt is made to explain the formation of the TAU phase with thermodynamics. For this reason the Gibbs free energy changes for TAU and zeta phases were calculated. The excess free energy for the system was calculated with the Redlich-Kister polyonyme. From this calculation it was deduced that the Gibbs energy change for the tau phase is negative. As a result its formation is spontaneous.

  11. Additive Manufacturing of a Microbial Fuel Cell—A detailed study

    PubMed Central

    Calignano, Flaviana; Tommasi, Tonia; Manfredi, Diego; Chiolerio, Alessandro

    2015-01-01

    In contemporary society we observe an everlasting permeation of electron devices, smartphones, portable computing tools. The tiniest living organisms on Earth could become the key to address this challenge: energy generation by bacterial processes from renewable stocks/waste through devices such as microbial fuel cells (MFCs). However, the application of this solution was limited by a moderately low efficiency. We explored the limits, if any, of additive manufacturing (AM) technology to fabricate a fully AM-based powering device, exploiting low density, open porosities able to host the microbes, systems easy to fuel continuously and to run safely. We obtained an optimal energy recovery close to 3 kWh m−3 per day that can power sensors and low-power appliances, allowing data processing and transmission from remote/harsh environments. PMID:26611142

  12. Preliminary study of neutron absorption by concrete with boron carbide addition

    SciTech Connect

    Abdullah, Yusof Yusof, Mohd Reusmaazran; Zali, Nurazila Mat; Ahmad, Megat Harun Al Rashid Megat; Yazid, Hafizal; Ariffin, Fatin Nabilah Tajul; Ahmad, Sahrim; Hamid, Roszilah; Mohamed, Abdul Aziz

    2014-02-12

    Concrete has become a conventional material in construction of nuclear reactor due to its properties like safety and low cost. Boron carbide was added as additives in the concrete construction as it has a good neutron absorption property. The sample preparation for concrete was produced with different weight percent of boron carbide powder content. The neutron absorption rate of these samples was determined by using a fast neutron source of Americium-241/Be (Am-Be 241) and detection with a portable backscattering neutron detector. Concrete with 20 wt % of boron carbide shows the lowest count of neutron transmitted and this indicates the most neutrons have been absorbed by the concrete. Higher boron carbide content may affect the concrete strength and other properties.

  13. Additive Manufacturing of a Microbial Fuel Cell--A detailed study.

    PubMed

    Calignano, Flaviana; Tommasi, Tonia; Manfredi, Diego; Chiolerio, Alessandro

    2015-11-27

    In contemporary society we observe an everlasting permeation of electron devices, smartphones, portable computing tools. The tiniest living organisms on Earth could become the key to address this challenge: energy generation by bacterial processes from renewable stocks/waste through devices such as microbial fuel cells (MFCs). However, the application of this solution was limited by a moderately low efficiency. We explored the limits, if any, of additive manufacturing (AM) technology to fabricate a fully AM-based powering device, exploiting low density, open porosities able to host the microbes, systems easy to fuel continuously and to run safely. We obtained an optimal energy recovery close to 3 kWh m(-3) per day that can power sensors and low-power appliances, allowing data processing and transmission from remote/harsh environments.

  14. Additive Manufacturing of a Microbial Fuel Cell—A detailed study

    NASA Astrophysics Data System (ADS)

    Calignano, Flaviana; Tommasi, Tonia; Manfredi, Diego; Chiolerio, Alessandro

    2015-11-01

    In contemporary society we observe an everlasting permeation of electron devices, smartphones, portable computing tools. The tiniest living organisms on Earth could become the key to address this challenge: energy generation by bacterial processes from renewable stocks/waste through devices such as microbial fuel cells (MFCs). However, the application of this solution was limited by a moderately low efficiency. We explored the limits, if any, of additive manufacturing (AM) technology to fabricate a fully AM-based powering device, exploiting low density, open porosities able to host the microbes, systems easy to fuel continuously and to run safely. We obtained an optimal energy recovery close to 3 kWh m-3 per day that can power sensors and low-power appliances, allowing data processing and transmission from remote/harsh environments.

  15. Preliminary study of neutron absorption by concrete with boron carbide addition

    NASA Astrophysics Data System (ADS)

    Abdullah, Yusof; Ariffin, Fatin Nabilah Tajul; Hamid, Roszilah; Yusof, Mohd Reusmaazran; Zali, Nurazila Mat; Ahmad, Megat Harun Al Rashid Megat; Yazid, Hafizal; Ahmad, Sahrim; Mohamed, Abdul Aziz

    2014-02-01

    Concrete has become a conventional material in construction of nuclear reactor due to its properties like safety and low cost. Boron carbide was added as additives in the concrete construction as it has a good neutron absorption property. The sample preparation for concrete was produced with different weight percent of boron carbide powder content. The neutron absorption rate of these samples was determined by using a fast neutron source of Americium-241/Be (Am-Be 241) and detection with a portable backscattering neutron detector. Concrete with 20 wt % of boron carbide shows the lowest count of neutron transmitted and this indicates the most neutrons have been absorbed by the concrete. Higher boron carbide content may affect the concrete strength and other properties.

  16. International Pediatric MS Study Group Clinical Trials Summit

    PubMed Central

    Tardieu, Marc; Amato, Maria Pia; Banwell, Brenda; Bar-Or, Amit; Ghezzi, Angelo; Kornberg, Andrew; Krupp, Lauren B.; Pohl, Daniela; Rostasy, Kevin; Tenembaum, Silvia; Waubant, Emmanuelle; Wassmer, Evangeline

    2013-01-01

    Objective: Pediatric studies for new biological agents are mandated by recent legislation, necessitating careful thought to evaluation of emerging multiple sclerosis (MS) therapies in children with MS. Challenges include a small patient population, the lack of prior randomized clinical trials, and ethical concerns. The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research. Methods: The Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion. A total of 69 meeting attendees were assembled, including 35 academic experts. Regulatory and pharmaceutical representatives also attended, and provided input, which informed academic expert consensus decisions. Results: The academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic, safety and efficacy data, and regulatory approval allowing for greater medication access. The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials. An international standardized cognitive battery was identified. The pros and cons of various trial designs were discussed. Guidelines surrounding MRI studies, pharmacokinetics, pharmacodynamics, and registries were developed. The academic experts agreed that given the limited subject pool, a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion. Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge. Conclusion: Consensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts, informed by regulatory and industry stakeholders. PMID:23509048

  17. Professional Competence Development of the Social Work Specialists in the Period of Study in the System of Additional Education

    ERIC Educational Resources Information Center

    Davletkaliev, Denis Kuanyshevich; Zueva, Natalia Konstantinovna; Lebedeva, Natalya Vasilevna; Mkrtumova, Irina Vladimirovna; Timofeeva, Olga

    2015-01-01

    The goal of this work is the study of psychological-pedagogical approaches to the understanding of the idea of professional competence of social work specialists as well as the role of study in the system of additional educations in professional-personal development of the listeners. In the process of study of this problem we define main…

  18. Spectroscopic Evidence for Covalent Binding of Sulfadiazine to Natural Soils via 1,4-nucleophilic addition (Michael Type Addition) studied by Spin Labeling ESR

    NASA Astrophysics Data System (ADS)

    Aleksandrova, Olga

    2015-04-01

    Among different classes of veterinary pharmaceuticals, Sulfadiazine (SDZ) is widely used in animal husbandry. Its residues were detected in different environmental compartments. However, soil is a hot spot for SDZ as it receives a large portion of excreted compounds through the application of manure during soil fertilization. Ample studies on the fate of SDZ in soils showed that a large portion forms nonextractable residues (NER) along with transformation products and a low mineralization (Mueller et al., 2013). A common observation was an initially fast formation of NER up to 10% of the applied amount promptly after the application of SDZ to soil, and this portion increased up to 50% within a few days (Mueller et al., 2013; Nowak et al., 2011). A common finding for SDZ, as for other sulfonamides, was biphasic kinetics of the formation of NER, which was attributed to the occurrence of two reaction processes: a rapid, often reversible process and a slower, irreversible process (Weber et al., 1996). A single-phase reaction process was also established under anaerobic treatment (Gulkowska et al., 2014). A major focus of this work is to elucidate a reaction mechanism of covalent binding of SDZ to soil that is currently required to estimate a risk of NER formed by SDZ in soils for human health. Taking into account a key role of the amine functional groups of SDZ on its reactivity in soil, nitroxide radicals with the sewed aromatic or aliphatic amines labeled soil samples and then, were investigated by means of ESR spectroscopy. 2,5,5-Trimethyl-2-(3-aminophenyl)pyrrolidin-1-yloxy and 4-amino-2,2,6,6-Tetramethylpiperidin-1-oxyl modeled decomposition products of SDZ with the aromatic and aliphatic amines, respectively. The application of the defined combination of both spin labels (SL) to different soils well simulated a change of a paramagnetic signal of soil organic radicals interacted with SDZ. After their application to soil, SL were found in soil sites characterized

  19. Using the Learning and Study Strategies Inventory Scores as Additional Predictors of Student Academic Performance.

    ERIC Educational Resources Information Center

    Rugsaken, Kris T.; Robertson, Jacqueline A.; Jones, James A.

    1998-01-01

    A study investigated the usefulness of the Learning and Study Strategies Inventory in predicting college students' academic performance, focusing on whether the scores enhance the accuracy of traditional predictors such as college entrance examinations and high school rank. Results indicate the scores produce a slight but not significant increase…

  20. Te Rita Papesch: Case Study of an Exemplary Learner of Maori as an Additional Language

    ERIC Educational Resources Information Center

    Ratima, Matiu Tai; Papesch, Te Rita

    2014-01-01

    This paper presents a case study of the life experiences of one exemplar adult second language Maori learner--Te Rita Papesch. Te Rita was one of 17 participants who were interviewed as a part of the first author's PhD study which sought to answer the question: what factors lead to the development of proficiency in te reo Maori amongst adult…

  1. Dengue Infection in Children in Ratchaburi, Thailand: A Cohort Study. II. Clinical Manifestations

    PubMed Central

    Sirivichayakul, Chukiat; Limkittikul, Kriengsak; Chanthavanich, Pornthep; Jiwariyavej, Vithaya; Chokejindachai, Watcharee; Pengsaa, Krisana; Suvannadabba, Saravudh; Dulyachai, Wut; Letson, G. William; Sabchareon, Arunee

    2012-01-01

    Background Dengue infection is one of the most important mosquito-borne diseases. More data regarding the disease burden and the prevalence of each clinical spectrum among symptomatic infections and the clinical manifestations are needed. This study aims to describe the incidence and clinical manifestations of symptomatic dengue infection in Thai children during 2006 through 2008. Study Design This study is a school-based prospective open cohort study with a 9,448 person-year follow-up in children aged 3–14 years. Active surveillance for febrile illnesses was done in the studied subjects. Subjects who had febrile illness were asked to visit the study hospital for clinical and laboratory evaluation, treatment, and serological tests for dengue infection. The clinical data from medical records, diary cards, and data collection forms were collected and analyzed. Results Dengue infections were the causes of 12.1% of febrile illnesses attending the hospital, including undifferentiated fever (UF) (49.8%), dengue fever (DF) (39.3%) and dengue hemorrhagic fever (DHF) (10.9%). Headache, anorexia, nausea/vomiting and myalgia were common symptoms occurring in more than half of the patients. The more severe dengue spectrum (i.e., DHF) had higher temperature, higher prevalence of nausea/vomiting, abdominal pain, rash, diarrhea, petechiae, hepatomegaly and lower platelet count. DHF cases also had significantly higher prevalence of anorexia, nausea/vomiting and abdominal pain during day 3–6 and diarrhea during day 4–6 of illness. The absence of nausea/vomiting, abdominal pain, diarrhea, petechiae, hepatomegaly and positive tourniquet test may predict non-DHF. Conclusion Among symptomatic dengue infection, UF is most common followed by DF and DHF. Some clinical manifestations may be useful to predict the more severe disease (i.e., DHF). This study presents additional information in the clinical spectra of symptomatic dengue infection. PMID:22389735

  2. Autism and genetics: Clinical approach and association study with two markers of HRAS gene

    SciTech Connect

    Herault, J.; Petit, E.; Cherpi, C.

    1995-08-14

    Twin studies and familial aggregation studies indicate that genetic factors could play a role in infantile autism. In an earlier study, we identified a possible positive association between autism and a c-Harvey-ras (HRAS) oncogene marker at the 3{prime} end of the coding region. In an attempt to confirm this finding, we studied a larger population, well-characterized clinically and genetically. We report a positive association between autism and two HRAS markers, the 3{prime} marker used in the initial study and an additional marker in exon 1. 46 refs., 1 fig., 2 tabs.

  3. Sensitization to Food Additives in Patients with Allergy: A Study Based on Skin Test and Open Oral Challenge.

    PubMed

    Moghtaderi, Mozhgan; Hejrati, Zinatosadat; Dehghani, Zahra; Dehghani, Faranak; Kolahi, Niloofar

    2016-06-01

    There has been a great increase in the consumption of various food additives in recent years. The purpose of this study was to identify the incidence of sensitization to food additives by using skin prick test in patients with allergy and to determine the concordance rate between positive skin tests and oral challenge in hypersensitivity to additives. This cross-sectional study included 125 (female 71, male 54) patients aged 2-76 years with allergy and 100 healthy individuals. Skin tests were performed in both patient and control groups with 25 fresh food additives. Among patients with allergy, 22.4% showed positive skin test at least to one of the applied materials. Skin test was negative to all tested food additives in control group. Oral food challenge was done in 28 patients with positive skin test, in whom 9 patients showed reaction to culprit (Concordance rate=32.1%). The present study suggested that about one-third of allergic patients with positive reaction to food additives showed positive oral challenge; it may be considered the potential utility of skin test to identify the role of food additives in patients with allergy.

  4. Clinical impact of genetic studies in lethal inherited cardiac arrhythmias.

    PubMed

    Shimizu, Wataru

    2008-12-01

    Over the past decade, molecular genetic studies have established a link between a number of inherited cardiac arrhythmias, including congenital long QT syndrome (LQTS) and Brugada syndrome (BrS), and mutations in genes encoding for ion channels or other membrane components. Twelve forms of LQTS have been identified in 50-70% of clinically affected patients. Genotype-phenotype correlations have been rigorously investigated in LQT1, LQT2 and LQT3 syndromes, which constitute more than 90% of genotyped LQTS patients, enabling stratification of risk and effective treatment of genotyped patients. Genotype-specific triggers for both the cardiac events and the clinical course have been reported, and genotype-specific therapy has been already introduced. More recently, mutation site-specific differences in the clinical phenotype have been reported in LQT1 and LQT2 patients, indicating the possibility of mutation site-specific management or treatment. In contrast, only one-third of BrS patients can be genotyped, and data on genotype-phenotype relationships in clinical studies are limited. A Haplotype B consisting of 6 individual DNA polymorphisms within the proximal promoter region of the SCN5A gene was recently identified only in Asians (frequency 22%). Individuals with Haplotype B show significantly longer duration of both PQ and QRS than those without Haplotype B, indicating that Haplotype B likely contributes to the higher incidence of BrS in Asian populations.

  5. Exploratory studies of extended storage of apheresis platelets in a platelet additive solution (PAS).

    PubMed

    Slichter, Sherrill J; Corson, Jill; Jones, Mary Kay; Christoffel, Todd; Pellham, Esther; Bailey, S Lawrence; Bolgiano, Doug

    2014-01-09

    To evaluate the poststorage viability of apheresis platelets stored for up to 18 days in 80% platelet additive solution (PAS)/20% plasma, 117 healthy subjects donated platelets using the Haemonetics MCS+, COBE Spectra (Spectra), or Trima Accel (Trima) systems. Control platelets from the same subjects were compared with their stored test PAS platelets by radiolabeling their stored and control platelets with either (51)chromium or (111)indium. Trima platelets met Food and Drug Administration poststorage platelet viability criteria for only 7 days vs almost 13 days for Haemonetics platelets; ie, platelet recoveries after these storage times averaged 44 ± 3% vs 49 ± 3% and survivals were 5.4 ± 0.3 vs 4.6 ± 0.3 days, respectively. The differences in storage duration are likely related to both the collection system and the storage bag. The Spectra and Trima platelets were hyperconcentrated during collection, and PAS was added, whereas the Haemonetics platelets were elutriated with PAS, which may have resulted in less collection injury. When Spectra and Trima platelets were stored in Haemonetics' bags, poststorage viability was significantly improved. Platelet viability is better maintained in vitro than in vivo, allowing substantial increases in platelet storage times. However, implementation will require resolution of potential bacterial overgrowth during storage.

  6. Experimental study on agitated drying characteristics of sewage sludge under the effects of different additive agents.

    PubMed

    Deng, Wenyi; Su, Yaxin

    2014-07-01

    Drying experiments of dewatered sewage sludge (DSS) were conducted on a agitated paddle dryer, and the effects of additive agents, i.e., CaO, pulverized coal (PC), heavy oil (HO), and dried sludge ("DS" through back mixing) on the agitated drying characteristics of DSS were investigated. The results indicated that CaO can significantly increase the drying rate of DSS. The drying rate at CaO/DSS (mass ratio)=1/100 was 135% higher than that of CaO/DSS=0. Pulverized coal has no obvious effect on drying rate, but the increase of PC/DSS can promote breaking up of sludge lump. Heavy oil was found to be slightly effective in improving the drying rate of DSS in the examined experimental range of HO/DSS=0-1/20. It is also found that HO can reduce the torque of the dryer shaft, due to its lubrication effect. Back mixing of DS was found to be effective in alleviating the unfavorable effect of the lumpy phase by improving the mixing effect of the paddle dryer. There was a marked increase of drying rate with an increase of the DS/DSS in the experimental range of DS/DSS=0-1/3.

  7. Generalized linear and generalized additive models in studies of species distributions: Setting the scene

    USGS Publications Warehouse

    Guisan, A.; Edwards, T.C.; Hastie, T.

    2002-01-01

    An important statistical development of the last 30 years has been the advance in regression analysis provided by generalized linear models (GLMs) and generalized additive models (GAMs). Here we introduce a series of papers prepared within the framework of an international workshop entitled: Advances in GLMs/GAMs modeling: from species distribution to environmental management, held in Riederalp, Switzerland, 6-11 August 2001. We first discuss some general uses of statistical models in ecology, as well as provide a short review of several key examples of the use of GLMs and GAMs in ecological modeling efforts. We next present an overview of GLMs and GAMs, and discuss some of their related statistics used for predictor selection, model diagnostics, and evaluation. Included is a discussion of several new approaches applicable to GLMs and GAMs, such as ridge regression, an alternative to stepwise selection of predictors, and methods for the identification of interactions by a combined use of regression trees and several other approaches. We close with an overview of the papers and how we feel they advance our understanding of their application to ecological modeling. ?? 2002 Elsevier Science B.V. All rights reserved.

  8. Study on additional carrier sensing for IEEE 802.15.4 wireless sensor networks.

    PubMed

    Lee, Bih-Hwang; Lai, Ruei-Lung; Wu, Huai-Kuei; Wong, Chi-Ming

    2010-01-01

    Wireless sensor networks based on the IEEE 802.15.4 standard are able to achieve low-power transmissions in the guise of low-rate and short-distance wireless personal area networks (WPANs). The slotted carrier sense multiple access with collision avoidance (CSMA/CA) is used for contention mechanism. Sensor nodes perform a backoff process as soon as the clear channel assessment (CCA) detects a busy channel. In doing so they may neglect the implicit information of the failed CCA detection and further cause the redundant sensing. The blind backoff process in the slotted CSMA/CA will cause lower channel utilization. This paper proposes an additional carrier sensing (ACS) algorithm based on IEEE 802.15.4 to enhance the carrier sensing mechanism for the original slotted CSMA/CA. An analytical Markov chain model is developed to evaluate the performance of the ACS algorithm. Both analytical and simulation results show that the proposed algorithm performs better than IEEE 802.15.4, which in turn significantly improves throughput, average medium access control (MAC) delay and power consumption of CCA detection.

  9. Clinical risk factors for the development of consecutive exotropia: a comparative clinical study

    PubMed Central

    Taylan Sekeroglu, Hande; Erkan Turan, Kadriye; Karakaya, Jale; Sener, Emin Cumhur; Sanac, Ali Sefik

    2016-01-01

    AIM To compare a group of patients with consecutive exotropia with patients who had ≤10 prism diopters (PD) esotropia or no deviation postoperatively in terms of probable clinical risk factors for the development of consecutive exotropia. METHODS The study recruited fourteen patients who developed consecutive exodeviation during follow-up period after the correction of esotropia who were categorized as group 1 and thirty-one patients who had still ≤10 PD esotropia or no deviation at the final visit that were considered as group 2. Clinical risk factors leading the development of consecutive deviation were analyzed as the main outcome measures. RESULTS The mean age of patients was 4.57±3.11y in group 1 and 5.10±3.52y in group 2 (P=0.634). There was no significant difference of preoperative near and distant deviations among two groups (P=0.835, 0.928 respectively). The mean amount of medial rectus recession and lateral rectus resection was similar in both groups (P=0.412, 0.648 respectively). Convergence insufficiency and neurological diseases were more frequent in group 1 (P=0.007, 0.045). Accompanying neurological disease was found to be as a significant factor increasing the risk of the development of consecutive exotropia significantly [odds ratios (OR): 5.75 (1.04-31.93)]. CONCLUSION Accompanying neurological disease appears to be a significant clinical risk factor for the development of consecutive exodeviation during postoperative follow-up after the correction of esotropia. However, larger studies are needed in order to interpret the results to the clinical practice and to ascertain other concurrent risk factors. PMID:27366693

  10. Food additives

    PubMed Central

    Spencer, Michael

    1974-01-01

    Food additives are discussed from the food technology point of view. The reasons for their use are summarized: (1) to protect food from chemical and microbiological attack; (2) to even out seasonal supplies; (3) to improve their eating quality; (4) to improve their nutritional value. The various types of food additives are considered, e.g. colours, flavours, emulsifiers, bread and flour additives, preservatives, and nutritional additives. The paper concludes with consideration of those circumstances in which the use of additives is (a) justified and (b) unjustified. PMID:4467857

  11. Additional Study of Water Droplet Median Volume Diameter (MVD) Effects on Ice Shapes

    NASA Technical Reports Server (NTRS)

    Tsao, Jen-Ching; Anderson, David N.

    2005-01-01

    This paper reports the result of an experimental study in the NASA Glenn Icing Research Tunnel (IRT) to evaluate how well the MVD-independent effect identified previously might apply to SLD conditions in rime icing situations. Models were NACA 0012 wing sections with chords of 53.3 and 91.4 cm. Tests were conducted with a nominal airspeed of 77 m/s (150 kt) and a number of MVD's ranging from 15 to 100 m with LWC of 0.5 to 1 g/cu m. In the present study, ice shapes recorded from past studies and recent results at SLD and Appendix-C conditions are reviewed to show that droplet diameter is not important to rime ice shape for MVD of 30 microns or larger, but for less than 30 m drop sizes a rime ice shape transition from convex to wedge to spearhead type ice shape is observed.

  12. Study on Type C Coal Fly ash as an Additive to Molding Sand for Steel Casting

    NASA Astrophysics Data System (ADS)

    Palaniappan, Jayanthi

    2017-04-01

    Study of physio-chemical properties studies such as granulometric analysis, moisture, X ray fluorescence etc. were performed with Type C coal—combustion fly ash to investigate their potential as a distinct option for molding sand in foundry, thereby reducing the dependency on latter. Technological properties study such as compressive strength, tensile strength, permeability and compaction of various compositions of fly ash molding sand (10, 20 and 30 % fly ash substitute to chemically bonded sand) were performed and compared with silica molding sand. Steel casting production using this fly ash molding sand was done and the casting surface finish and typical casting parameters were assessed. It was noted that a good quality steel casting could be produced using type C fly ash molding sand, which effectively replaced 20 % of traditional molding sand and binders thereby providing greater financial profits to the foundry and an effective way of fly ash utilization (waste management).

  13. Voice measures of workload in the advanced flight deck: Additional studies

    NASA Technical Reports Server (NTRS)

    Schneider, Sid J.; Alpert, Murray

    1989-01-01

    These studies investigated acoustical analysis of the voice as a measure of workload in individual operators. In the first study, voice samples were recorded from a single operator during high, medium, and low workload conditions. Mean amplitude, frequency, syllable duration, and emphasis all tended to increase as workload increased. In the second study, NASA test pilots performed a laboratory task, and used a flight simulator under differing work conditions. For two of the pilots, high workload in the simulator brought about greater amplitude, peak duration, and stress. In both the laboratory and simulator tasks, high workload tended to be associated with more statistically significant drop-offs in the acoustical measures than were lower workload levels. There was a great deal of intra-subject variability in the acoustical measures. The results suggested that in individual operators, increased workload might be revealed by high initial amplitude and frequency, followed by rapid drop-offs over time.

  14. Study on Type C Coal Fly ash as an Additive to Molding Sand for Steel Casting

    NASA Astrophysics Data System (ADS)

    Palaniappan, Jayanthi

    2016-05-01

    Study of physio-chemical properties studies such as granulometric analysis, moisture, X ray fluorescence etc. were performed with Type C coal—combustion fly ash to investigate their potential as a distinct option for molding sand in foundry, thereby reducing the dependency on latter. Technological properties study such as compressive strength, tensile strength, permeability and compaction of various compositions of fly ash molding sand (10, 20 and 30 % fly ash substitute to chemically bonded sand) were performed and compared with silica molding sand. Steel casting production using this fly ash molding sand was done and the casting surface finish and typical casting parameters were assessed. It was noted that a good quality steel casting could be produced using type C fly ash molding sand, which effectively replaced 20 % of traditional molding sand and binders thereby providing greater financial profits to the foundry and an effective way of fly ash utilization (waste management).

  15. A Micro-Developmental Approach to Studying Young Children's Problem Solving Behavior in Addition

    ERIC Educational Resources Information Center

    Voutsina, Chronoula

    2012-01-01

    This paper presents a study that investigated the process of change in 5-6-year-old children's successful problem-solving approaches when tackling a multiple-step task in elementary arithmetic. Micro-developmental changes in children's successful problem-solving behavior were analyzed using Karmiloff-Smith's model of representational redescription…

  16. Genome-Wide Association Study of Intelligence: Additive Effects of Novel Brain Expressed Genes

    ERIC Educational Resources Information Center

    Loo, Sandra K.; Shtir, Corina; Doyle, Alysa E.; Mick, Eric; McGough, James J.; McCracken, James; Biederman, Joseph; Smalley, Susan L.; Cantor, Rita M.; Faraone, Stephen V.; Nelson, Stanley F.

    2012-01-01

    Objective: The purpose of the present study was to identify common genetic variants that are associated with human intelligence or general cognitive ability. Method: We performed a genome-wide association analysis with a dense set of 1 million single-nucleotide polymorphisms (SNPs) and quantitative intelligence scores within an ancestrally…

  17. A Study of the Effect of Additional Reading Assistance on Student Achievement

    ERIC Educational Resources Information Center

    Gillan-Sanderson, Nicole A.

    2012-01-01

    This study describes a procedure one school district used to increase students' reading abilities through reviewing data and adjusting the instruction to give students intensive services, as needed. This school worked in a problem-solving team approach to develop a comprehensive team that followed the progression of student achievement.…

  18. Nahuatl as a Classical, Foreign, and Additional Language: A Phenomenological Study

    ERIC Educational Resources Information Center

    De Felice, Dustin

    2012-01-01

    In this study, participants learning an endangered language variety shared their experiences, thoughts, and feelings about the often complex and diverse language-learning process. I used phenomenological interviews in order to learn more about these English or Spanish language speakers' journey with the Nahuatl language. From first encounter to…

  19. CNV-based genome wide association study reveals additional variants contributing to meat quality in swine

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Pork quality is important both to the meat processing industry and consumers’ purchasing attitudes. Copy number variation (CNV) is a burgeoning kind of variant that may influence meat quality. Herein, a genome-wide association study (GWAS) was performed between CNVs and meat quality traits in swine....

  20. Smarter candidate selection--utilizing microdosing in exploratory clinical studies.

    PubMed

    Buchan, P

    2007-01-01

    Microdosing offers a faster and potentially less expensive approach to obtaining human in vivo PK data in early clinical drug development. It encompasses the use of pharmacologically inactive doses of test drug in the low microgram range along with ultrasensitive assay methods (PET, AMS) to assess human exposure in order to extrapolate the PK of higher, clinically more relevant doses, assuming linear PK. This strategy allows early evaluation of systemic clearance, oral bioavailability as well as sources of intersubject variability and questions of specific metabolite formation. It does take advantage of reduced regulatory requirements of preclinical safety studies, bulk drug synthesis (CMC requirements) and easier formulation options, e.g., as part of an exploratory IND; however, this is counterbalanced by a need to synthesize radiolabeled test compound and the development of a sophisticated analytical method. Ongoing studies will determine the predictability of human PK using Microdosing methods.

  1. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes

    PubMed Central

    Sharma, Deepak K.; Solbrig, Harold R.; Prud’hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary’s metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration. PMID:28269909

  2. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

    PubMed

    Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

  3. Repurposing metformin for cancer treatment: current clinical studies

    PubMed Central

    Chae, Young Kwang; Arya, Ayush; Malecek, Mary-Kate; Shin, Daniel Sanghoon; Carneiro, Benedito; Chandra, Sunandana; Kaplan, Jason; Kalyan, Aparna; Altman, Jessica K.; Platanias, Leonidas; Giles, Francis

    2016-01-01

    In recent years, several studies have presented evidence suggesting a potential role for metformin in anti-cancer therapy. Preclinical studies have demonstrated several anticancer molecular mechanisms of metformin including mTOR inhibition, cytotoxic effects, and immunomodulation. Epidemiologic data have demonstrated decreased cancer incidence and mortality in patients taking metformin. Several clinical trials, focused on evaluation of metformin as an anti-cancer agent are presently underway. Data published from a small number of completed trials has put forth intriguing results. Clinical trials in pre-surgical endometrial cancer patients exhibited a significant decrease in Ki67 with metformin monotherapy. Another interesting observation was made in patients with breast cancer, wherein a trend towards improvement in cancer proliferation markers was noted in patients without insulin resistance. Data on survival outcomes with the use of metformin as an anti-cancer agent is awaited. This manuscript will critically review the role of metformin as a potential cancer treatment. PMID:27004404

  4. Thermal analysis studies of Ge additive of Se-Te glasses

    NASA Astrophysics Data System (ADS)

    Mohamed, M.; Abdel-Rahim, M. A.

    2016-04-01

    Ge x Se50Te50- x ( x = 5, 15, 20, 35 at.%) bulk glasses were synthesized by the melt quenching method. The amorphous nature of the investigated glasses was determined by X-ray diffraction. Results of differential scanning calorimetry (DSC) of the studied compositions under non-isothermal conditions were reported and discussed. The glass transition temperature ( T g), onset crystallization temperature ( T c), and crystallization peak temperature ( T p) were determined from DSC traces at different heating rates. It was found that the values of T g, T c, and T p rely on both composition and heating rate. A double crystallization stages were observed in the DSC results. Various kinetics parameters such as the glass transition energy ( E g), crystallization activation energy ( E c), and rate constant ( K p) were calculated. The glass-forming ability of the studied compositions was discussed as function of the determined kinetics parameters.

  5. Comparative study of glycine single crystals with additive of potassium nitrate in different concentration ratios

    NASA Astrophysics Data System (ADS)

    Gujarati, Vivek P.; Deshpande, M. P.; Patel, Kamakshi R.; Chaki, S. H.

    2016-05-01

    Semi-organic crystals of Glycine Potassium Nitrate (GPN) with potential applications in Non linear optics (NLO) were grown using slow evaporation technique. Glycine and Potassium Nitrate were taken in three different concentration ratios of 3:1, 2:1 and 1:1 respectively. We checked the solubility of the material in distilled water at different temperatures and could observe the growth of crystals in 7 weeks time. Purity of the grown crystals was confirmed by Energy Dispersive X-ray Analysis (EDAX) and CHN analysis. GSN Powder X-ray diffraction pattern was recorded to confirm the crystalline nature. To confirm the applications of grown crystals in opto-electronics field, UV-Vis-NIR study was carried out. Dielectric properties of the samples were studied in between the frequency range 1Hz to 100 KHz.

  6. Brief reconnaissance study for the addition of hydropower for Carr Fork Dam, Sassafras, Kentucky

    SciTech Connect

    Gebhard, T.G. Jr.

    1982-05-24

    The feasibility of retrofitting the Carr Fork Dam near Hazard, KY for power generation was examined. This dam has a developable head of 80 ft and was built in 1975 to provide flood protection. The study of environmental, institutional, safety, and economic factors showed that the total investment cost would be $909,600 and that hydroelectric power development at this site is not feasible unless a higher price could be obtained for the power sold. (LCL)

  7. Brief reconnaissance study for the addition of hydropower for Spray Dam, Eden, North Carolina

    SciTech Connect

    Gebhard, T.G. Jr.

    1981-01-30

    The feasibility of retrofitting the Spray Dam near Eden, North Carolina for power generation was examined. This dam has a developable head of 10 ft., was built in 1898 for hydroelectric power generation with one of 2 installed units currently operating. The study of environmental, institutional, safety and economic factors showed that hydroelectric power development at this site is possible and that the economics of retrofits will depend on whether existing equipment can be repaired or will have to be replaced. (LCL)

  8. Additional studies of sheep haemopexin: genetic control, frequencies and postnatal development.

    PubMed

    Stratil, A; Bobák, P; Margetín, M; Glasnák, V

    1989-01-01

    This study presents evidence that sheep haemopexin phenotypes are genetically controlled by three alleles, HpxA, HpxB1 and HpxB2, of a single autosomal locus. Frequencies of two alleles, HpxA and HpxB (HpxB encompasses two isoalleles, HpxB1 and HpxB2), were studied in eight sheep breeds in Czechoslovakia. The frequency of the HpxA allele was highest (ranging from 0.81 in Merino to 1.0 in East Friesian sheep). Qualitative and quantitative changes in haemopexin during postnatal development were studied by starch gel electrophoresis and rocket immunoelectrophoresis respectively. In electrophoresis, 1- or 2-day-old lambs had two very weak zones corresponding in mobility to two slower zones of adult animals. Later, the third more anodic zone appeared and gradually increased in intensity. In 1-month-old lambs the patterns were practically identical with those of adult animals. Using rocket immunoelectrophoresis, the level of haemopexin shortly after birth was practically zero. It rose sharply till the sixth day of life; then the level continued to rise slowly till about 1 month of age. The mean haemopexin level in adult sheep was 64.5 +/- 18.26 (SD) mg/100ml serum, ranging from 30.5 to 116.5 mg/100ml.

  9. [Clinical and microbiological study of adult periodontal disease].

    PubMed

    Nogueira Moreira, A; Fernández Canigia, L; Furman, C; Chiappe, V; Marcantoni, M; Bianchini, H

    2001-01-01

    The aim of this study was to carry out a microbiological evaluation of sites with and without clinical evidence of moderate and severe periodontitis and their correlation with clinical parameters. A total of 52 disease sites and 10 healthy sites were selected according to clinical criteria. The following clinical indexes were measured for all the sites: plaque index, gingival index, blood on probing, depth on probing and insertion level. Samples of subgingival plaque were collected for culture and for differential counts of microbial morphotypes. In disease sites the most frequently isolated were: Prevotella intermedia/nigrescens (65%), Porphyromonas gingivalis (23%), Actinobacillus actinomycetemcomitans (23%), Fusobacterium nucleatum (10%) and Peptostreptococcus sp. (31%). The aerobic gram-positive microflora was predominant in healthy sites. Significant differences were observed in microbial morphotypes between healthy and disease sites: cocci 18.71% and 78.90%, motile rods 46.12% and 16.70%, total spirochetes 26.48% and 2.80%, respectively. The presence of motile rods, spirochetes and P. intermedia/nigrescens were the parameters with most sensitivity to suspect periodontal disease. There were significant differences in the subgingival microflora between healthy and disease sites in patients with moderate and severe periodontitis.

  10. Pilot Study of a Clinical Pathway Implementation in Rectal Cancer

    PubMed Central

    Uña, Esther; López-Lara, Francisco

    2010-01-01

    Background: Rectal cancer is a highly prevalent disease which needs a multidisciplinary approach to be treated. The absence of specific protocols implies a significant and unjustifiable variability among the different professionals involved in this disease. The purpose is to develop a clinical pathway based on the analysis process and aims to reduce this variability and to reduce unnecessary costs. Methods: We created a multidisciplinary team with contributors from every clinical area involved in the diagnosis and treatment in this disease. We held periodic meetings to agree on a protocol based on the best available clinical practice guidelines. Once we had agreed on the protocol, we implemented its use as a standard in our institution. Every patient older than 18 years who was diagnosed with rectal cancer was considered a candidate to be treated via the pathway. Results: We evaluated 48 patients during the course of this study. Every parameter measured was improved after the implementation of the pathway, except the proportion of patients with 12 nodes or more analysed. The perception that our patients had about this project was very good. Conclusions: Clinical pathways are needed to improve the quality of health care. This kind of project helps reduce hospital costs and optimizes the use of limited resources. On the other hand, unexplained variability is also reduced, with consequent benefits for the patients. PMID:21151842

  11. Examining an ethical dilemma: a case study in clinical practice.

    PubMed

    Narrigan, Deborah

    2004-01-01

    When clients and health care providers differ in their understanding of what is right or wrong, an ethical dilemma may arise. Such dilemmas occur in everyday clinical practice. Health care providers have the professional responsibility to analyze these dilemmas. A clinical case study of an ethical dilemma that occurred in a cross-cultural context is examined. The language of the client and provider differed, and no interpreter service was available. Given these conditions, the provider's ethical dilemma was whether, and if so how, to give safe, satisfying care that respected the needs of a client with limited English proficiency. Measuring the morality of the provider's decisions and actions using Rawls' ethical theory of social justice finds deficits. A 10-step Bioethical Decision-Making Model by Thompson is used to demonstrate one method for analyzing the moral dimension of a clinical scenario focusing on the decisions and actions taken by a midwife. Scrutinizing ethically challenging clinical encounters will result in better understanding of the moral dimensions of practice.

  12. Therapeutic horticulture in clinical depression: a prospective study.

    PubMed

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p < .001) and were clinically relevant (deltaBDI > or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

  13. Implementing an expressive writing study in a cancer clinic.

    PubMed

    Morgan, Nancy P; Graves, Kristi D; Poggi, Elizabeth A; Cheson, Bruce D

    2008-02-01

    Patients at a comprehensive cancer center have participated in a weekly writing program for 7 years. Anecdotal evidence following writing in this clinical setting appeared congruent with the results of expressive writing studies conducted in laboratory settings. To move expressive writing research beyond the laboratory, we evaluated the feasibility of engaging a clinical population in a structured expressive writing task while they waited for an appointment in a cancer clinic. Adult leukemia and lymphoma patients (n = 71) completed a baseline assessment, 20-minute writing task, postwriting assessment, and 3-week follow-up; 88% completed the writing task and 56% completed the follow-up. Participants reported positive responses to the writing, and immediately postwriting about half (49.1%) reported that writing resulted in changes in their thoughts about their illness, while 53.8% reported changes in their thoughts at the 3-week follow-up. Reports of changes in thoughts about illness immediately postwriting were significantly associated with better physical quality of life at follow-up, controlling for baseline quality of life. Initial qualitative analyses of the texts identified themes related to experiences of positive change/transformation following a cancer diagnosis. Findings support the feasibility of conducting expressive writing with a clinical population in a nonlaboratory setting. Cancer patients were receptive to expressive writing and reported changes in the way they thought about their illness following writing. These preliminary findings indicate that a single, brief writing exercise is related to cancer patients' reports of improved quality of life.

  14. Studies of biochemistry and clinical biochemistry. Studies at sample medical schools in 13 EU countries regarding biochemistry and clinical biochemistry teaching.

    PubMed

    Stern, Petr; Sebesta, Ivan; Trnkova, Bohuslava; Zima, Tomas

    2008-07-01

    The study summarizes the results obtained during personal visits to 53 medical schools in the 13 original EU countries during 2004--2006. Data from the Czech Republic is shown for comparison. The possibilities of acquiring information from the websites of the medical schools in the local language and English are assessed. The admission process to medical schools and the organization of studies of medicine, dentistry, and non-medical healthcare fields are briefly characterized. Significant attention is paid to the forms of education in biochemistry and clinical (bio)chemistry in the medical study field. The position of these subjects in the studies of dentistry and non-medical healthcare fields is also noted. In addition, the course of subject exams is described. The methods of funding and postgraduate studies at the medical schools are also briefly addressed.

  15. Novel approaches to incorporating pharmacoeconomic studies into phase III clinical trials for Alzheimer's disease.

    PubMed

    Fillit, H; Cummings, J; Neumann, P; McLaughlin, T; Salavtore, P; Leibman, C

    2010-10-01

    The societal and individual costs of Alzheimer's disease are significant, worldwide. As the world ages, these costs are increasing rapidly, while health systems face finite budgets. As a result, many regulators and payers will require or at least consider phase III cost-effectiveness data (in addition to safety and efficacy data) for drug approval and reimbursement, increasing the risks and costs of drug development. Incorporating pharmacoeconomic studies in phase III clinical trials for Alzheimer's disease presents a number of challenges. We propose several specific suggestions to improve the design of pharmacoeconomic studies in phase III clinical trials. We propose that acute episodes of care are key outcome measures for pharmacoeconomic studies. To improve the possibility of detecting a pharmacoeconomic impact in phase III, we suggest several strategies including; study designs for enrichment of pharmacoeconomic outcomes that include co-morbidity of patients; reducing variability of care that can affect pharmacoeconomic outcomes through standardized care management; employing administrative claims data to better capture meaningful pharmacoeconomic data; and extending clinical trials in open label follow-up periods in which pharmacoeconomic data are captured electronically by administrative claims. Specific aspects of power analysis for pharmacoeconomic studies are presented. The particular pharmacoeconomic challenges caused by the use of biomarkers in clinical trials, the increasing use of multinational studies, and the pharmacoeconomic challenges presented by biologicals in development for Alzheimer's disease are discussed. In summary, since we are entering an era in which pharmacoeconomic studies will be essential in drug development for supporting regulatory approval, payor reimbursement and integration of new therapies into clinical care, we must consider the design and incorporation of pharmacoeconomic studies in phase III clinical trials more seriously

  16. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study

    PubMed Central

    Halbach, Nicky; Julu, Peter; Witt‐Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F.; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-01-01

    Many studies have attempted to establish the genotype–phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well‐defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype–phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non‐invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence‐based management in RTT. © 2016 The Authors. American Journal of Medical Genetics Part A published by Wiley Periodicals, Inc. PMID:27354166

  17. Evaluating outpatient transition clinics: a mixed-methods study protocol

    PubMed Central

    Sattoe, Jane N T; Peeters, Mariëlle A C; Hilberink, Sander R; Ista, Erwin; van Staa, AnneLoes

    2016-01-01

    Introduction To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC). Methods and analysis We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care. Ethics The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246). Dissemination Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016

  18. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  19. [Anatomical and radiological studies on additional mandible teeth anesthesia considering innervation variability].

    PubMed

    Tarasenko, S V; Dydykin, S S; Kuzin, A V

    2013-01-01

    The paper presents studies on nutritional foramina of the mandible. Some nutritional foramina located in the frontal mandibular region on the lingual surface and containing significant blood vessels and nerves are found to be more typical for teeth-bearing mandible. In retromolar area in case of third molars presence intraosseous canals were revealed leading to inferior alveolar nerve canal. One should consider intraligamental and lingual anesthesia by lower incisors extraction. Intraosseous anesthesia and retromolar area infiltration significantly increase anesthesia efficiency by third molar extraction.

  20. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study.

    PubMed

    DeFrino, Paul Francis; Brodsky, James White; Pollo, Fabian E; Crenshaw, Stephanie J; Beischer, Andrew D

    2002-06-01

    This study investigated the results of first metatarsophalangeal (MTP) arthrodesis in terms of clinical outcome measures, plantar pressure distribution, and gait patterns. Ten feet in nine patients with severe hallux rigidus (HR) who underwent first MTP arthrodesis were studied. The preoperative evaluation included a subjective questionnaire, physical exam, AOFAS hallux score, radiographs and dynamic pedobarography (EMED). At follow-up (average 34 months) these were repeated, and gait analysis studies were obtained. Patients showed significant clinical improvement based on the subjective criteria. The mean AOFAS score improved from 38 preoperatively to 90 postoperatively. Postoperative EMED analysis showed restoration of the weightbearing function of the first ray, with greater maximum force carried by the distal hallux at toe-off. Kinematic and kinetic gait analysis from each patient's operative limb were compared to the unaffected contralateral limb and to age- and sex-matched healthy subjects. The kinematic data indicated a significantly shorter step length with some loss in ankle plantar flexion at toe-off on the fused side. The kinetic data indicated a reduction in both ankle torque and ankle power at push-off. Clinical results indicated effective pain relief and a high level of patient satisfaction, consistent with previous reports in patients with symptomatic Hallux Rigidus.

  1. Clinical utility of corpus callosum measurements in head sonograms of preterm infants: a cohort study

    PubMed Central

    Perenyi, Agnes; Amodio, John; Katz, Joanne S; Stefanov, Dimitre G

    2013-01-01

    Objective To assess the clinical usefulness of measurement of corpus callosum (CC) size in head ultrasound (HUS) to predict short-term neurodevelopmental (ND) outcomes in preterm infants. We hypothesised that including CC measurements in routine HUS will be an additional tool for early identification of infants at risk of adverse short-term ND outcome, over and above the predictive power of perinatal morbidities. Design Retrospective cohort study. Setting Level III neonatal intensive care unit (NICU) and outpatient NICU follow-up clinic of an academic medical centre in New York City. Participants 929 HUS of 502 infants with gestational age of 23–36 weeks in African-American infants were initially studied. Exclusion criteria included those who died, had gross abnormalities in HUS, infants with race other than African-American, infants with suboptimal quality of HUS, late preterm infants and infants who did not participate in ND follow-up. A total of 173 infants completed the study. Interventions CC size (length and thickness) was measured in a subset of 87 infants who had routine HUS between 23 and 29 weeks (0–6 postnatal weeks). Relevant clinical variables were collected from chart reviews. ND assessments were completed in outpatient follow-up clinics. A statistical model was developed to assess the clinical utility and possible predictive value of CC measurements for adverse short-term ND outcome, while adjusting for perinatal morbidities. Primary and secondary outcome measures CC size and ND status. Results Measurements of CC size did not add substantial predictive power to predict short-term ND outcome beyond the information provided by the presence of morbidities related to prematurity. Conclusions No association was found between morbidities related to prematurity and short-term ND outcome and CC size in preterm infants. CC measurements in HUS early in life did not have an additional value in predicting short-term ND outcome, therefore did not seem to

  2. Study on the interaction of the toxic food additive carmoisine with serum albumins: a microcalorimetric investigation.

    PubMed

    Basu, Anirban; Kumar, Gopinatha Suresh

    2014-05-30

    The interaction of the synthetic azo dye and food colorant carmoisine with human and bovine serum albumins was studied by microcalorimetric techniques. A complete thermodynamic profile of the interaction was obtained from isothermal titration calorimetry studies. The equilibrium constant of the complexation process was of the order of 10(6)M(-1) and the binding stoichiometry was found to be 1:1 with both the serum albumins. The binding was driven by negative standard molar enthalpy and positive standard molar entropy contributions. The binding affinity was lower at higher salt concentrations in both cases but the same was dominated by mostly non-electrostatic forces at all salt concentrations. The polyelectrolytic forces contributed only 5-8% of the total standard molar Gibbs energy change. The standard molar enthalpy change enhanced whereas the standard molar entropic contribution decreased with rise in temperature but they compensated each other to keep the standard molar Gibbs energy change almost invariant. The negative standard molar heat capacity values suggested the involvement of a significant hydrophobic contribution in the complexation process. Besides, enthalpy-entropy compensation phenomenon was also observed in both the systems. The thermal stability of the serum proteins was found to be remarkably enhanced on binding to carmoisine.

  3. Are gastric hyperplastic polyps an additional manifestation in celiac disease?: Results from a retrospective study.

    PubMed

    Dore, Maria Pina; Pes, Giovanni Mario; Rocchi, Chiara; Loria, Maria Francesca; Soro, Sara; Bassotti, Gabrio

    2017-02-01

    Gastric polyps are frequently reported in patients undergoing upper endoscopic procedures. In this retrospective study, the association between hyperplastic polyps and celiac disease in Northern Sardinia was estimated.Age, gender, body mass index, and medications taken in the 2 preceding months, including proton-pump inhibitors (PPIs), H2 receptor blockers (anti-H2), Helicobacter pylori status, endoscopic findings, and histology from charts of patients undergoing esophago-gastro-duodenoscopy were reviewed. Polyps were classified as hyperplastic, fundic gland, inflammatory, and adenomatous.3.7% (423/11379) patients had celiac disease. Prevalence of gastric polyps was 4.2% (3.8% among celiac vs 4.2% nonceliac patients). Inflammatory polyp was the most common histotype (55.8% and 56.2%) followed by fundic gland polyps (31.4% and 43.7%), hyperplastic (8.7% and 0%), and adenomas, in celiac and nonceliac patients, respectively. Fundic gland polyps were more common in PPI users (odds ratio: 4.06) than in nonusers (2.65, P = 0.001) among celiac and nonceliac patients. Age older than 50, female gender, esophago-gastro-duodenoscopy year, and PPI use were associated with the presence of polyps, whereas active H pylori infection was not.Gastric polyps were common in Sardinian patients undergoing esophago-gastro-duodenoscopy. However, the previously reported association between hyperplastic polyps and celiac disease was not confirmed in our study.

  4. [Chewing gum as an additional agent in maintaining oral hygiene versus smoking status--preliminary study].

    PubMed

    Nakonieczna-Rudnicka, Marta; Strycharz-Dudziak, Małgorzata; Bachanek, Teresa

    2012-01-01

    Nowadays chewing gum is widely used in different age groups, so complying with proper duration and frequency of chewing is an important factor influencing the state of masticatory system. The study involved 112 dental students of the Medical University of Lublin. Everyday use of chewing gum declared 47,32% of cases. Chewing time up to 10 minutes was stated in 23,08% of respondents, 11-20 minutes in 40,38% of interviewees. Among the examined students 17,3% smoked cigarettes. In smokers group 83,33% of questioned chewed the gum every day, while among non-smokers - 43,37%. Chewing time shorter than 10 minutes declared 22,22% of smokers and 23,26% of non-smokers, while chewing time between 11-20 minutes - 27,78% i 44,35% of smokers and non-smokers respectively. Obtained results indicate the need of carrying out further studies aimed at the nicotine influence on saliva parameters with respect to development of diseases of hard tooth tissues.

  5. A clinical forensic scientist in the burns unit: necessity or not? A prospective clinical study.

    PubMed

    Yasti, Ahmet Cinar; Tumer, Ali Riza; Atli, Mesut; Tutuncu, Tanju; Derinoz, Ali; Kama, Nuri Aydin

    2006-02-01

    Child abuse by burning is a common means of assault that may be difficult to prove. Even though well trained in burns management physicians on the burn team may not be sufficiently qualified to clarify the medicolegal aspects of the incident. In Turkey, physicians have a responsibility to notify the law offices of injury to children caused by any non-accidental mechanism including neglect. The consequences of false positive and/or false negative reports to the legal offices may be damaging for the care-takers and/or the children. In our study, 239 consecutively hospitalized children with burns were studied prospectively. A clinical forensic scientist and a physician of the burns team interpreted incidents separately so that neither had an idea about the other's diagnoses until the end of the study. There were found to be some differences in the interpretation of the incidents by the clinical forensic scientist and the burns team physician. These differences were described as discordant diagnoses. The physician accepted 99 (41.4%) of the incidents as an accident while only 66 (27.6%) of the victims were labelled as accidents by the forensic scientist. A multivariate analysis identified low socioeconomic status, aged between 3 and 6 years, and a family size of more than six as independent variables significantly associated with discordant diagnoses (p = 0.0388, 0.0001, 0.0203, respectively). As a conclusion, we suggest that to minimize the likelihood of a legally inaccurate diagnosis, a clinical forensic scientist seems to be necessary in the emergency department.

  6. Shelf life and quality study of minced tilapia with Nori and Hijiki seaweeds as natural additives.

    PubMed

    Ribeiro, Ingridy Simone; Shirahigue, Ligianne Din; Ferraz de Arruda Sucasas, Lia; Anbe, Lika; da Cruz, Pedro Gomes; Gallo, Cláudio Rosa; Carpes, Solange Teresinha; Marques, Marcos José; Oetterer, Marília

    2014-01-01

    The extraction of mechanically separated meat has emerged as an attractive process. However, it increases the incorporation of oxygen and, consequently, of flavors due to rancidity. Thus, preservatives must be added. The objective of this study was to evaluate the shelf life of minced tilapia to replace synthetic preservatives with Hijiki and Nori seaweeds extracts. The application of the extracts had no effect on the chemical composition of the minced tilapia. The seaweed extracts had inhibitory effect on total volatile base nitrogen. The minced tilapia complied with the microbiological standard set by Brazilin law. The panelists detected no differences in the rancid aroma and only minor differences were detected in the color of the products. It can be concluded that the minced tilapia with added seaweed extracts were within quality standards during frozen storage.

  7. Additional results for 'Sequential design approaches for bioequivalence studies with crossover designs'.

    PubMed

    Montague, Timothy H; Potvin, Diane; Diliberti, Charles E; Hauck, Walter W; Parr, Alan F; Schuirmann, Donald J

    2012-01-01

    In 2008, this group published a paper on approaches for two-stage crossover bioequivalence (BE) studies that allowed for the reestimation of the second-stage sample size based on the variance estimated from the first-stage results. The sequential methods considered used an assumed GMR of 0.95 as part of the method for determining power and sample size. This note adds results for an assumed GMR = 0.90. Two of the methods recommended for GMR = 0.95 in the earlier paper have some unacceptable increases in Type I error rate when the GMR is changed to 0.90. If a sponsor wants to assume 0.90 for the GMR, Method D is recommended. Copyright © 2011 John Wiley & Sons, Ltd.

  8. Shelf Life and Quality Study of Minced Tilapia with Nori and Hijiki Seaweeds as Natural Additives

    PubMed Central

    Ribeiro, Ingridy Simone; Shirahigue, Ligianne Din; Ferraz de Arruda Sucasas, Lia; Anbe, Lika; da Cruz, Pedro Gomes; Gallo, Cláudio Rosa; Carpes, Solange Teresinha; Marques, Marcos José; Oetterer, Marília

    2014-01-01

    The extraction of mechanically separated meat has emerged as an attractive process. However, it increases the incorporation of oxygen and, consequently, of flavors due to rancidity. Thus, preservatives must be added. The objective of this study was to evaluate the shelf life of minced tilapia to replace synthetic preservatives with Hijiki and Nori seaweeds extracts. The application of the extracts had no effect on the chemical composition of the minced tilapia. The seaweed extracts had inhibitory effect on total volatile base nitrogen. The minced tilapia complied with the microbiological standard set by Brazilin law. The panelists detected no differences in the rancid aroma and only minor differences were detected in the color of the products. It can be concluded that the minced tilapia with added seaweed extracts were within quality standards during frozen storage. PMID:25478593

  9. Biological effect of food additive titanium dioxide nanoparticles on intestine: an in vitro study.

    PubMed

    Song, Zheng-Mei; Chen, Ni; Liu, Jia-Hui; Tang, Huan; Deng, Xiaoyong; Xi, Wen-Song; Han, Kai; Cao, Aoneng; Liu, Yuanfang; Wang, Haifang

    2015-10-01

    Titanium dioxide nanoparticles (TiO2 NPs) are widely found in food-related consumer products. Understanding the effect of TiO2 NPs on the intestinal barrier and absorption is essential and vital for the safety assessment of orally administrated TiO2 NPs. In this study, the cytotoxicity and translocation of two native TiO2 NPs, and these two TiO2 NPs pretreated with the digestion simulation fluid or bovine serum albumin were investigated in undifferentiated Caco-2 cells, differentiated Caco-2 cells and Caco-2 monolayer. TiO2 NPs with a concentration less than 200 µg ml(-1) did not induce any toxicity in differentiated cells and Caco-2 monolayer after 24 h exposure. However, TiO2 NPs pretreated with digestion simulation fluids at 200 µg ml(-1) inhibited the growth of undifferentiated Caco-2 cells. Undifferentiated Caco-2 cells swallowed native TiO2 NPs easily, but not pretreated NPs, implying the protein coating on NPs impeded the cellular uptake. Compared with undifferentiated cells, differentiated ones possessed much lower uptake ability of these TiO2 NPs. Similarly, the traverse of TiO2 NPs through the Caco-2 monolayer was also negligible. Therefore, we infer the possibility of TiO2 NPs traversing through the intestine of animal or human after oral intake is quite low. This study provides valuable information for the risk assessment of TiO2 NPs in food.

  10. Governance for clinical decision support: case studies and recommended practices from leading institutions

    PubMed Central

    Sittig, Dean F; Ash, Joan S; Bates, David W; Feblowitz, Joshua; Fraser, Greg; Maviglia, Saverio M; McMullen, Carmit; Nichol, W Paul; Pang, Justine E; Starmer, Jack; Middleton, Blackford

    2011-01-01

    Objective Clinical decision support (CDS) is a powerful tool for improving healthcare quality and ensuring patient safety; however, effective implementation of CDS requires effective clinical and technical governance structures. The authors sought to determine the range and variety of these governance structures and identify a set of recommended practices through observational study. Design Three site visits were conducted at institutions across the USA to learn about CDS capabilities and processes from clinical, technical, and organizational perspectives. Based on the results of these visits, written questionnaires were sent to the three institutions visited and two additional sites. Together, these five organizations encompass a variety of academic and community hospitals as well as small and large ambulatory practices. These organizations use both commercially available and internally developed clinical information systems. Measurements Characteristics of clinical information systems and CDS systems used at each site as well as governance structures and content management approaches were identified through extensive field interviews and follow-up surveys. Results Six recommended practices were identified in the area of governance, and four were identified in the area of content management. Key similarities and differences between the organizations studied were also highlighted. Conclusion Each of the five sites studied contributed to the recommended practices presented in this paper for CDS governance. Since these strategies appear to be useful at a diverse range of institutions, they should be considered by any future implementers of decision support. PMID:21252052

  11. Clinical experiences with Creutzfeldt-Jakob disease: three case studies.

    PubMed

    Szucs, Anna; Várallyay, Péter; Osztie, Eva; Papp, Erzsébet; Sólyom, András; Finta, Lehel; Varga, Dániel; Barcs, Gábor; Holló, András; Kamondi, Anita

    2012-11-30

    The clinical picture, electroencephalographic, imaging and cerebrospinal fluid parameters as well as the molecular background of Creutzfeldt-Jakob disease have been well explored. The diagnostic criteria, offering clinicians a fair chance to identify these patients in vivo, have recently been updated. However, the diagnosis is still a challenge in everyday neurological routine. We report on three of our Creutzfeldt-Jakob patients for calling attention to the classical and the recently defined features of the disease. We conclude that based on the rapidly progressing neuropsychiatric syndrome Creutzfeldt-Jakob disease may be suspected; follow-up EEG may reveal the typical (pseudo)-periodic pattern with progressive deterioration of the background activity. In addition, diffusion-weighted brain MRI imaging (DWI) has high diagnostic value. Detection of 14-3-3 protein in the cerebrospinal fluid supports the in vivo diagnosis.

  12. [Studies on preanalytical phase errors in clinical chemistry in the Japanese clinical laboratory--now and the future].

    PubMed

    Tomita, Akio; Kizawa, Senji

    2007-05-01

    The Sampling Conference for the prevention of preanalytical phase errors was first held at Fukushima in 1987. Since then, The Sampling Conference has been held in several areas in Japan. For the same purpose, we started the Tokai Sampling Conference in the Tokai area including Aichi, Shizuoka, Gifu and Mie prefectures in 1990, and discussed clinical errors in laboratory measurements caused by physiological variations in age, sex and the season, influence of food, exercise, posture and medication, effects of anticoagulants, sample storage conditions and so on. We have studied many preanalytical errors at these conferences. Moreover, additional problems have been revealed at the conferences. Safety and risk management to avoid needle sticks and Vacutainer-induced infections have been discussed, and this information is thought to be important not only for laboratory workers but also for patients.

  13. A Comparative Kirkwood-Buff Study of Aqueous Methanol Solutions Modeled by the CHARMM Additive and Drude Polarizable Force Fields

    PubMed Central

    Lin, Bin; He, Xibing; MacKerell, Alexander D.

    2013-01-01

    A comparative study on aqueous methanol solutions modeled by the CHARMM additive and Drude polarizable force fields was carried out by employing Kirkwood-Buff analysis. It was shown that both models reproduced the experimental Kirkwood-Buff integrals and excess coordination numbers adequately well over the entire concentration range. The Drude model showed significant improvement over the additive model in solution densities, partial molar volumes, excess molar volumes, concentration-dependent diffusion constants, and dielectric constants. However, the additive model performed somewhat better than the Drude model in reproducing the activity derivative, excess molar Gibbs energy and excess molar enthalpy of mixing. This is due to the additive achieving a better balance among solute-solute, solute-solvent, and solvent-solvent interactions, indicating the potential for improvements in the Drude polarizable alcohol model. PMID:23947568

  14. Blood pressure goal achievement with olmesartan medoxomil-based treatment: additional analysis of the OLMEBEST study

    PubMed Central

    Barrios, Vivencio; Escobar, Carlos; Calderon, Alberto; Böhm, Michael

    2009-01-01

    Aims Guidelines recommend blood pressure (BP) in hypertensive patients should be <140 systolic BP (SBP) and <90 diastolic BP (DBP) mmHg. This analysis assessed goal rate achievement in hypertensive patients receiving olmesartan-based treatment in the OLMEBEST study. Methods Patients with essential hypertension (DBP ≥ 90 mmHg and <110 mmHg) received open-label olmesartan medoxomil 20 mg/day (n = 2306). After 8 weeks, patients with DBP ≥ 90 mmHg (n = 627) were randomized to 4 weeks’ double-blind treatment with olmesartan 40 mg/day monotherapy or olmesartan 20 mg/day plus hydrochlorothiazide (HCTZ) 12.5 mg/day. For this analysis, the numbers and proportions of patients who achieved SBP < 140 mmHg and/or DBP < 90 mmHg at the end of the 4 weeks were calculated. Results In patients who achieved DBP normalization (<90 mmHg) at week 8 (n = 1546) and continued open-label olmesartan 20 mg/day, 66.7% achieved SBP/DBP < 140/90 mmHg at Week 12. In patients who did not achieve DBP normalization at Week 8, 26.8% of those randomized to olmesartan 40 mg/day and 42.5% of those randomized to olmesartan 20 mg/day plus HCTZ 12.5 mg/day achieved a SBP/DBP < 140/90 mmHg at Week 12. Conclusion Olmesartan 40 mg/day and olmesartan 20 mg/day plus HCTZ 12.5 mg/day allow substantial proportions of patients to achieve BP goals. PMID:19756164

  15. Additional erythrocytic and reticulocytic parameters helpful for diagnosis of hereditary spherocytosis: results of a multicentre study.

    PubMed

    Mullier, François; Lainey, Elodie; Fenneteau, Odile; Da Costa, Lydie; Schillinger, Françoise; Bailly, Nicolas; Cornet, Yvan; Chatelain, Christian; Dogne, Jean-Michel; Chatelain, Bernard

    2011-07-01

    Hereditary spherocytosis (HS) is characterised by weakened vertical linkages between the membrane skeleton and the red blood cell's lipid bilayer, leading to the release of microparticles. All the reference tests suffer from specific limitations. The aim of this study was to develop easy to use diagnostic tool for screening of hereditary spherocytosis based on routinely acquired haematological parameters like percentage of microcytes, percentage of hypochromic cells, reticulocyte counts, and percentage of immature reticulocytes. The levels of haemoglobin, mean cell volume, mean corpuscular haemoglobin concentration, reticulocytes (Ret), immature reticulocytes fraction (IRF), hypochromic erythrocytes (Hypo-He) and microcytic erythrocytes (MicroR) were determined on EDTA samples on Sysmex instruments from a cohort of 45 confirmed SH. The HS group was then compared with haemolytical disorders, microcytic anaemia, healthy individuals and routine samples (n = 1,488). HS is characterised by a high Ret count without an equally elevated IRF. All 45 HS have Ret >80,000/μl and Ret(10(9)/L)/IRF (%) greater than 7.7 (rule 1). Trait and mild HS had a Ret/IRF ratio greater than 19. Moderate and severe HS had increased MicroR and MicroR/Hypo-He (rule 2). Combination of both rules gave predictive positive value and negative predictive value of respectively 75% and 100% (n=1,488), which is much greater than single parameters or existing rules. This simple and fast diagnostic method could be used as an excellent screening tool for HS. It is also valid for mild HS, neonates and ABO incompatibilities and overcomes the lack of sensitivity of electrophoresis in ankyrin deficiencies.

  16. Myofacial pain dysfunction syndrome: a clinical study of asymptomatic subjects.

    PubMed

    Cooper, B C; Rabuzzi, D D

    1984-01-01

    The diagnosis of myofacial pain dysfunction (MPD), commonly called temporomandibular joint syndrome, has traditionally been made on the presence of a group of clinical symptoms that produce pain and limitation of movement. The cause of this common illness has been the subject of controversy for over half a century. There has been a lack of agreement on diagnosis, a cause, and treatment. Advanced bioelectronic technology now makes an accurate diagnosis possible, based not merely on clinical symptoms, but on reproducible scientific data. A cause of MPD is discernable and reliable treatment possible, as well as long lasting resolution objectively monitorable with the Mandibular Kinesiograph (MKG 5-R) and Bioelectric Processor (EMIR). A study of mandibular movement and masticular muscle function of 26 "normal" subjects (i.e., clinically asymptomatic) revealed that the overwhelming majority did indeed have dysfunction of the muscles which move and posture the mandible. The significance of this study is twofold. First it demonstrates a valid testing procedure for measuring mandibular movement and muscle function. Second it establishes the fact that most individuals have a physical predisposition to MPD. Changes in the adaptive capacity of the neuromusculature by physical or emotional trauma could then precipitate MPD.

  17. Study of clinically suspected onychomycosis in a podiatric population.

    PubMed

    Jennings, Maureen B; Weinberg, Jeffrey M; Koestenblatt, Evelyn K; Lesczczynski, Christine

    2002-06-01

    Onychomycosis, by definition, is a mycotic infection of the keratinized tissue of the nail plate. Although it is commonly considered to be caused by one of the dermatotropic fungi, a variety of other organisms have been implicated as etiologic agents in the disease, including some bacteria and yeasts. When it is caused by a fungus, any or all of three types of organisms can be involved: dermatophytes, yeasts, and nondermatophyte organisms. The purpose of this study was to identify the microorganisms found in fungal cultures of clinically suspected onychomycosis in the patient population of the Foot Clinics of New York in New York City, the largest foot clinic in the world. Of the 1,800 medical charts reviewed, 214 had culture results, of which 120 were positive. Trichophyton rubrum was the most prevalent pathogen, found in 67% of positive cultures. The most remarkable risk factor was age, with 80% of affected individuals older than 35 years. False-negatives may account for the high percentage (44%) of negative cultures in this study.

  18. Cancer therapy with phytochemicals: evidence from clinical studies

    PubMed Central

    Hosseini, Azar; Ghorbani, Ahmad

    2015-01-01

    Cancer is still one of the major causes of mortality in both developing and developed countries. At present, in spite of intensive interventions, a large number of patients suffer from poor prognosis. Therefore, the effort for finding new anticancer agents with better efficacy and lesser side effects has been continued. According to the traditional recommendations and experimental studies, numerous medicinal plants have been reported to have anticancer effect. Also antiproliferative, pro-apoptotic, anti-metastatic and anti-angiogenic effects of several phytochemicals have been shown in in vitro experiments or animal studies. However, only a small number have been tested in cancerous patients and limited evidence exists for their clinical effectiveness. Also, regarding some phytochemicals, only beneficial effects on cancer-related symptoms or on quality of life have been reported and no positive results exist for their antitumor actions. This review was focused on the phytochemicals whole beneficial effects on various types of cancer have been supported by clinical trials. Based on the literature review, curcumin, green tea, resveratrol and Viscum album were the satisfactory instances of clinical evidence for supporting their anticancer effects. The main findings of these phytochemicals were also summarized and discussed. PMID:25949949

  19. A clinical research analytics toolkit for cohort study.

    PubMed

    Yu, Yiqin; Zhu, Yu; Sun, Xingzhi; Tao, Ying; Zhang, Shuo; Xu, Linhao; Pan, Yue

    2012-01-01

    This paper presents a clinical informatics toolkit that can assist physicians to conduct cohort studies effectively and efficiently. The toolkit has three key features: 1) support of procedures defined in epidemiology, 2) recommendation of statistical methods in data analysis, and 3) automatic generation of research reports. On one hand, our system can help physicians control research quality by leveraging the integrated knowledge of epidemiology and medical statistics; on the other hand, it can improve productivity by reducing the complexities for physicians during their cohort studies.

  20. Outside enclosure and additional enrichment for dairy goats – a preliminary study

    PubMed Central

    2012-01-01

    Background Dairy goats are commonly housed at a space allowance of 0.7 – 0.8 m2/goat in commercial Norwegian goat herds, which is very low compared to regulations and recommendations in other European countries. One easy and cheap way to increase space allowance is to allow the animals’ access to outdoor area. The aim of this study was to investigate the effect of access to an outside enclosure and environmental enrichment for dairy goats kept in slatted floor pens with low space allowance on their activity pattern and social behaviour. Methods A group of 82 dairy goats on a commercial Norwegian dairy farm were kept inside during the winter period from October to April. In April the goats were given access to an outside enclosure for 8 hours per day. After having access to the enclosure for another for two days, enrichment (branches) was provided, and after 19 days the enrichment were removed. The goats were observed for 5 hours per day for the two last days before they got access to the outside enclosure, the two days in the enclosure, the two first and the two last days with enrichment and for the following two days without enrichment by two trained observers. Results When allowed access to the enclosure, the goats spent nearly 50% of the time outside, and later the time spent outside was reduced to less than 40% (P < 0.0001), but there was no clear effect of enrichment. All the goats appeared to have a regular use of the enclosure. Time spent resting decreased 59.2% to only 25.2% when the goats first got access to the enclosure, but then started to increase again (P < 0.0001). Initially time spent exploring and chewing the branches was 20%, but this was reduced to around 12% in the last part of the ENRICH period (P < 0.0001). Number of aggressive interactions tended to increase when the goats were allowed access to the outdoor enclosure whereas play behaviour was only observed in the outside enclosure (P < 0.05). Conclusions In conclusion

  1. [Clinical manifestations, complications and treatment of brucellosis: 45-patient study].

    PubMed

    Zribi, M; Ammari, L; Masmoudi, A; Tiouiri, H; Fendri, C

    2009-07-01

    The aim of this study was to evaluate the clinical, laboratory findings and therapeutic features of patients with brucellosis. The diagnosis was made by clinical findings, automated blood culture, serology (Rose Bengal plate agglutination test, standard tube agglutination (Wright) and immunofluorerescence). The susceptibility of 13 strains was tested in vitro. The base sequence was determined for four strains. Forty-five cases were collected (31 acute and 14 sub-acute). Contamination was digestive in 62%. Symptoms of patients were fever (93%), sweating (82%), arthralgia (78%) and splenomegaly (51%). Elevated erythrocyte sedimentation rate was determined in 80%, leukopenia in 49% and anaemia in 37% of cases. Blood cultures were positives in 39% of cases. The four sequenced strains were identified as Brucella melitensis biovar abortus. Six strains were resistant to sufomethoxazol-trimetoprim (54%). In 93% of cases, the treatment was associated rifampicin and doxycyclin. One patient died. No relapse was reported.

  2. Nurse-managed wound clinic. A case study in success.

    PubMed

    Crumbley, D R; Ice, R C; Cassidy, R

    1999-01-01

    The wound Care Clinic at Naval Hospital Charleston is a nurse-managed ambulatory clinic that has demonstrated the successful application of nursing case management in caring for patients with chronic and complex wounds. Nursing case management is an outcomes-based system of assessment, planning, provision of nursing services, coordination of interdisciplinary efforts, education, and referral. Nursing case management has been shown, in the literature and at Naval Hospital Charleston, to be an extension of role of professional nursing practice and results in decreased costs, improved quality of care, faster wound healing times, decreased complications, and greater coordination of care between specialty disciplines. These positive results are illustrated in several case studies. Nursing case management has many implications for the successful implementation of any healthcare delivery system where decreased costs and improved quality of care are valued, and it has special benefit in the complex management of chronically ill patients.

  3. Prevention of missing data in clinical research studies.

    PubMed

    Wisniewski, Stephen R; Leon, Andrew C; Otto, Michael W; Trivedi, Madhukar H

    2006-06-01

    Missing data is a problem that is ubiquitous to all clinical studies and a source of multiple problems from an analytic point of view (reduced statistical power, increased the type I error, bias) Statistical approaches have been developed to analyze data collected from trials with missing data. Understanding and implementing the appropriate statistical technique is essential but should be differentiated from preventive approaches that are designed to reduce rates of missing data In this article, we draw attention to these preventive efforts. Seven steps to minimizing the amount of missing data are defined as documentation, training, monitoring reports, patient contact, data entry and management, pilot studies, and communication. Although the implementation of these approaches is time consuming and costly, the overall quality of the study is increased. Despite efforts devoted to areas, no study is without missing data. Once the study is completed, it is essential to assess the pattern of missing data and apply the appropriate statistical analysis.

  4. Comparative study of clinical grade human tolerogenic dendritic cells

    PubMed Central

    2011-01-01

    Background The use of tolerogenic DCs is a promising therapeutic strategy for transplantation and autoimmune disorders. Immunomodulatory DCs are primarily generated from monocytes (MDDCs) for in vitro experiments following protocols that fail to fulfil the strict regulatory rules of clinically applicable products. Here, we compared the efficacy of three different tolerance-inducing agents, dexamethasone, rapamycin and vitamin D3, on DC biology using GMP (Good Manufacturing Practice) or clinical grade reagents with the aim of defining their use for human cell therapy. Methods Tolerogenic MDDCs were generated by adding tolerogenic agents prior to the induction of maturation using TNF-α, IL-β and PGE2. We evaluated the effects of each agent on viability, efficiency of differentiation, phenotype, cytokine secretion and stability, the stimulatory capacity of tol-DCs and the T-cell profiles induced. Results Differences relevant to therapeutic applicability were observed with the cellular products that were obtained. VitD3-induced tol-DCs exhibited a slightly reduced viability and yield compared to Dexa-and Rapa-tol-DCs. Phenotypically, while Dexa-and VitD3-tol-DCs were similar to immature DCs, Rapa-tol-DCs were not distinguishable from mature DCs. In addition, only Dexa-and moderately VitD3-tol-DCs exhibited IL-10 production. Interestingly, in all cases, the cytokine secretion profiles of tol-DCs were not modified by a subsequent TLR stimulation with LPS, indicating that all products had stable phenotypes. Functionally, clearly reduced alloantigen T cell proliferation was induced by tol-DCs obtained using any of these agent. Also, total interferon-gamma (IFN-γ) secretion by T cells stimulated with allogeneic tol-DCs was reduced in all three cases, but only T cells co-cultured with Rapa-tol-DCs showed impaired intracellular IFN-γ production. In addition, Rapa-DCs promoted CD4+ CD127 low/negative CD25high and Foxp3+ T cells. Conclusions Our results demonstrate

  5. Food additives

    MedlinePlus

    ... or natural. Natural food additives include: Herbs or spices to add flavor to foods Vinegar for pickling ... Certain colors improve the appearance of foods. Many spices, as well as natural and man-made flavors, ...

  6. IMPACT - Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model

    PubMed Central

    2014-01-01

    Background Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM. Methods/Design This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works. Discussion The US health care

  7. Imaging cardiac stem cell therapy: translations to human clinical studies.

    PubMed

    Zhang, Wendy Y; Ebert, Antje D; Narula, Jagat; Wu, Joseph C

    2011-08-01

    Stem cell therapy promises to open exciting new options in the treatment of cardiovascular diseases. Although feasible and clinically safe, the in vivo behavior and integration of stem cell transplants still remain largely unknown. Thus, the development of innovative non-invasive imaging techniques capable of effectively tracking such therapy in vivo is vital for a more in-depth investigation into future clinical applications. Such imaging modalities will not only generate further insight into the mechanisms behind stem cell-based therapy, but also address some major concerns associated with translational cardiovascular stem cell therapy. In the present review, we summarize the principles underlying three major stem cell tracking methods: (1) radioactive labeling for positron emission tomography (PET) and single photon emission computed tomography (SPECT) imaging, (2) iron particle labeling for magnetic resonance imaging (MRI), and (3) reporter gene labeling for bioluminescence, fluorescence, MRI, SPECT, and PET imaging. We then discuss recent clinical studies that have utilized these modalities to gain biological insights into stem cell fate.

  8. [Quality of the clinical reports: observational study in Sassari].

    PubMed

    Virdis, A; Licheri, N; Ruiu, A

    2009-01-01

    Within the program of clinical risk management, and in particular in the phase of the "knowledge" of company reality, the work deals with the topic of the case history in Sassari' local health authority. A study is treated where, on a sample of about 400 cases history, four definite aspects are considered, in particular those that are regarded as the most important in the risk management and about medical responsability: 1) formal consent; 2) daily clinical allowance; 3) therapeutic card; 4) operating card. The results we got show the presence of a formal consent filled in correctly in 36 cases (9%), completed a daily allowance in 36 cases (9%), therapeutic card in 14 (3.5%) cases, operation card in 21 cases (19% su 116 surgical cases). These data, that have permitted to estimate the specific company reality as from pointed out critical states, show the necessity of working, with involvement of professional doctors, to build a history case model with clear and shared rules where you can clearly find the clinical path of a patient, where everything made is quoted and easily readable when necessary.

  9. 3D ultrasound computer tomography: update from a clinical study

    NASA Astrophysics Data System (ADS)

    Hopp, T.; Zapf, M.; Kretzek, E.; Henrich, J.; Tukalo, A.; Gemmeke, H.; Kaiser, C.; Knaudt, J.; Ruiter, N. V.

    2016-04-01

    Ultrasound Computer Tomography (USCT) is a promising new imaging method for breast cancer diagnosis. We developed a 3D USCT system and tested it in a pilot study with encouraging results: 3D USCT was able to depict two carcinomas, which were present in contrast enhanced MRI volumes serving as ground truth. To overcome severe differences in the breast shape, an image registration was applied. We analyzed the correlation between average sound speed in the breast and the breast density estimated from segmented MRIs and found a positive correlation with R=0.70. Based on the results of the pilot study we now carry out a successive clinical study with 200 patients. For this we integrated our reconstruction methods and image post-processing into a comprehensive workflow. It includes a dedicated DICOM viewer for interactive assessment of fused USCT images. A new preview mode now allows intuitive and faster patient positioning. We updated the USCT system to decrease the data acquisition time by approximately factor two and to increase the penetration depth of the breast into the USCT aperture by 1 cm. Furthermore the compute-intensive reflectivity reconstruction was considerably accelerated, now allowing a sub-millimeter volume reconstruction in approximately 16 minutes. The updates made it possible to successfully image first patients in our ongoing clinical study.

  10. Cannabis and Schizophrenia Spectrum Disorders: A Review of Clinical Studies

    PubMed Central

    Rodrigo, Chaturaka; Rajapakse, Senaka

    2009-01-01

    Cannabis is the most widely used illegitimate substance in the world, and the number of users has increased by 10% over the last decade worldwide. Therefore, it is important to review the evidence on psychoactive properties of cannabis and its possible association with schizophrenia spectrum disorders (SSD). We searched MEDLINE with the key words cannabis and schizophrenia. The search was limited to articles published in English over the last 10 years (1999-2009). Bibliographies of cited literature were also searched. Data sources included reviews published in core clinical journals, cohort studies, interventional studies, case-control studies, cross-sectional analyses and epidemiological data. Results are discussed under 2 topics. Firstly, evidence related to biochemical functioning of cannabinoids and their relationship to endocannabinoid system is discussed briefly. Secondly, the evidence from clinical studies on cannabis, psychosis proneness and SSD are discussed in detail. The discussion is structured to fit in the evidence from results section to 3 plausible hypotheses on cannabis use and SSD. The evidence for and against each hypothesis is discussed. Despite new evidence, the exact relationship between cannabis and SSD is unclear. There is no firm evidence that cannabis causes SSD. The evidence for the argument that schizophrenic patients are attracted to cannabis is also not strong. The most plausible explanation is that cannabis use and psychosis proneness may have synergistic effects in a vulnerable minority. PMID:21938097

  11. STUDY OF THE EFFECT OF CHLORINE ADDITION ON MERCURY OXIDATION BY SCR CATALYST UNDER SIMULATED SUBBITUMINOUS COAL FLUE GAS

    EPA Science Inventory

    An entrained flow reactor is used to study the effect of addition of chlorine-containing species on the oxidation of elemental mercury (Hgo)by a selective catalytic reduction (SCR) catalyst in simulated subbituminous coal combustion flue gas. The combustion flue gas was doped wit...

  12. Effect of Additives on Green Sand Molding Properties using Design of Experiments and Taguchi's Quality Loss Function - An Experimental Study

    NASA Astrophysics Data System (ADS)

    Desai, Bhagyashree; Mokashi, Pavani; Anand, R. L.; Burli, S. B.; Khandal, S. V.

    2016-09-01

    The experimental study aims to underseek the effect of various additives on the green sand molding properties as a particular combination of additives could yield desired sand properties. The input parameters (factors) selected were water and powder (Fly ash, Coconut shell and Tamarind) in three levels. Experiments were planned using design of experiments (DOE). On the basis of plans, experiments were conducted to understand the behavior of sand mould properties such as compression strength, shear strength, permeability number with various additives. From the experimental results it could be concluded that the factors have significant effect on the sand properties as P-value found to be less than 0.05 for all the cases studied. The optimization based on quality loss function was also performed. The study revealed that the quality loss associated with the tamarind powder was lesser compared to other additives selected for the study. The optimization based on quality loss function and the parametric analysis using ANOVA suggested that the tamarind powder of 8 gm per Kg of molding sand and moisture content of 7% yield better properties to obtain sound castings.

  13. A Pilot Study to Examine the Effect of Additional Structured Outdoor Playtime on Preschoolers' Physical Activity Levels

    ERIC Educational Resources Information Center

    Alhassan, Sofiya; Nwaokelemeh, Ogechi; Lyden, Kate; Goldsby, TaShauna; Mendoza, Albert

    2013-01-01

    The impact of additional structured outdoor playtime on preschoolers'; physical activity (PA) level is unclear. The purpose of this pilot study was to explore the effects of increasing structured outdoor playtime on preschoolers'; PA levels. Eight full-day classrooms (n = 134 children) from two preschool programmes were randomised into a treatment…

  14. Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment

    PubMed Central

    Willemsen, Jochem; Della Rosa, Elena; Kegerreis, Sue

    2017-01-01

    This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases. PMID:28210235

  15. Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment.

    PubMed

    Willemsen, Jochem; Della Rosa, Elena; Kegerreis, Sue

    2017-01-01

    This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases.

  16. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Committee advises the Chief Research and Development Officer through the Director of the Clinical...

  17. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  18. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Research and Development Officer through the Director of the Clinical Science Research and...

  19. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  20. Clinical research education study teams: a research curriculum for obstetric and gynecology residents.

    PubMed

    Brubaker, Linda; Kenton, Kimberly

    2011-06-01

    Research education is a requirement for obstetrics and gynecology residents. Most obstetrics and gynecology residencies struggle with barriers to efficient, effective research education and productivity for their residents. These barriers include constraints on faculty time, lack of intrinsic desire within individual residents, and lack of relevant outcome measures. We developed an efficient, novel research education curriculum that overcomes many of these barriers and provides obstetrics and gynecology residents with a structured format that maximizes the likelihood of a successful, positive research experience. Since the start of the Clinical Research Education Study Team program, the graduating resident cohorts reliably complete and present prospective research projects, including three registered randomized trials. Residency-wide support for other team research has grown dramatically. The residents' work was acknowledged with several research awards, which further reinforces the positive perception of the program. The certainty of completion of their research requirement relieved our residents of the anxiety commonly reported by residents nearing graduation. The Clinical Research Education Study Team program's team design makes efficient use of faculty time. In addition, Clinical Research Education Study Team mentors also have incorporated junior faculty members who wish to improve their own research education skills. We offer our experience with this program in hopes that it may be of value to other programs that wish to improve their resident research education curriculum. It remains important for residents to acquire research skills before continuing into practice or fellowship. The Clinical Research Education Study Team program facilitates this education in an efficient, organized manner.

  1. Electrophysiological Mechanisms of Brugada Syndrome: Insights from Pre-clinical and Clinical Studies

    PubMed Central

    Tse, Gary; Liu, Tong; Li, Ka H. C.; Laxton, Victoria; Chan, Yin W. F.; Keung, Wendy; Li, Ronald A.; Yan, Bryan P.

    2016-01-01

    Brugada syndrome (BrS), is a primary electrical disorder predisposing affected individuals to sudden cardiac death via the development of ventricular tachycardia and fibrillation (VT/VF). Originally, BrS was linked to mutations in the SCN5A, which encodes for the cardiac Na+ channel. To date, variants in 19 genes have been implicated in this condition, with 11, 5, 3, and 1 genes affecting the Na+, K+, Ca2+, and funny currents, respectively. Diagnosis of BrS is based on ECG criteria of coved- or saddle-shaped ST segment elevation and/or T-wave inversion with or without drug challenge. Three hypotheses based on abnormal depolarization, abnormal repolarization, and current-load-mismatch have been put forward to explain the electrophysiological mechanisms responsible for BrS. Evidence from computational modeling, pre-clinical, and clinical studies illustrates that molecular abnormalities found in BrS lead to alterations in excitation wavelength (λ), which ultimately elevates arrhythmic risk. A major challenge for clinicians in managing this condition is the difficulty in predicting the subset of patients who will suffer from life-threatening VT/VF. Several repolarization risk markers have been used thus far, but these neglect the contributions of conduction abnormalities in the form of slowing and dispersion. Indices incorporating both repolarization and conduction and based on the concept of λ have recently been proposed. These may have better predictive values than the existing markers. PMID:27803673

  2. Posttraumatic stress disorder and physical illness: results from clinical and epidemiologic studies.

    PubMed

    Boscarino, Joseph A

    2004-12-01

    Research indicates that exposure to traumatic stressors and psychological trauma is widespread. The association of such exposures with posttraumatic stress disorder (PTSD) and other mental health conditions is well known. However, epidemiologic research increasingly suggests that exposure to these events is related to increased health care utilization, adverse health outcomes, the onset of specific diseases, and premature death. To date, studies have linked traumatic stress exposures and PTSD to such conditions as cardiovascular disease, diabetes, gastrointestinal disease, fibromyalgia, chronic fatigue syndrome, musculoskeletal disorders, and other diseases. Evidence linking cardiovascular disease and exposure to psychological trauma is particularly strong and has been found consistently across different populations and stressor events. In addition, clinical studies have suggested the biological pathways through which stressor-induced diseases may be pathologically expressed. In particular, recent studies have implicated the hypothalamic-pituitary-adrenal (HPA) and the sympathetic-adrenal-medullary (SAM) stress axes as key in this pathogenic process, although genetic and behavioral/psychological risk factors cannot be ruled out. Recent findings, indicating that victims of PTSD have higher circulating T-cell lymphocytes and lower cortisol levels, are intriguing and suggest that chronic sufferers of PTSD may be at risk for autoimmune diseases. To test this hypothesis, we assessed the association between chronic PTSD in a national sample of 2,490 Vietnam veterans and the prevalence of common autoimmune diseases, including rheumatoid arthritis, psoriasis, insulin-dependent diabetes, and thyroid disease. Our analyses suggest that chronic PTSD, particularly comorbid PTSD or complex PTSD, is associated with all of these conditions. In addition, veterans with comorbid PTSD were more likely to have clinically higher T-cell counts, hyperreactive immune responses on

  3. Clinical and economic studies of eptifibatide in coronary stenting.

    PubMed

    Pasala, Tilak; Sattayaprasert, Prasongchai; Bhat, Pradeep K; Athappan, Ganesh; Gandhi, Sanjay

    2014-01-01

    Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin), who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant), routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications). Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access) is unknown. This review provides an overview of key clinical and economic studies of eptifibatide well into the current era of potent antiplatelet agents, novel safer anticoagulants, and contemporary percutaneous coronary intervention.

  4. Clinical Study of 224 Patients with Hypertriglyceridemia Pancreatitis

    PubMed Central

    Zhang, Xiao-Li; Li, Fei; Zhen, Ya-Min; Li, Ang; Fang, Yu

    2015-01-01

    Background: Hypertriglyceridemia (HTG) is the most common etiology of acute pancreatitis (AP) after alcohol and gallstone-induced disease. Elevation of serum triglyceride (TG) levels to ≥1000 mg/dl in a patient with AP strongly indicates HTG as the cause. The absolute risk of pancreatitis based on serum TG ≤1000 mg/dl has not been clearly defined. The aims of this study were to address the role of elevated TG levels between 500 and 1000 mg/dl in the clinical course of HTG pancreatitis (HTGP); and assess the relationship between the level of serum TG and disease severity. Methods: A total of 224 HTGP patients between 2007 and 2011 were divided into two subgroups. Totally, 122 patients in Group A had serum TG >1000 mg/dl; 102 patients in Group B had maximal TG levels between 500 and 1000 mg/dl accompanied by lactescent serum; 100 patients with biliary AP and 99 patients with alcoholic AP hospitalized during the study period were enrolled as controls. The clinical and biochemical data were analyzed. Results: The clinical presentation of HTG-induced pancreatitis was similar to other causes. Severe form of AP in Group A was higher than Group B (χ2 = 4.002, P = 0.045). The severity with HTGP was significantly higher as compared to biliary AP (χ2 = 33.533, P = 0.000) and alcoholic AP (χ2 = 7.179, P = 0.007). Systemic complications with HTGP were significantly higher than biliary AP (χ2 = 58.763, P = 0.000). Conclusions: The study demonstrated that TG level ≥500 mg/dl should raise a high degree of suspicion, especially if no other etiology of AP is apparent. The severity of HTGP seems to correlate directly with TG level. HTGP seems be more severe than other causes of AP. PMID:26228216

  5. Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design.

    PubMed

    Lee, Caroline A; O'Connor, Meeghan A; Ritchie, Tasha K; Galetin, Aleksandra; Cook, Jack A; Ragueneau-Majlessi, Isabelle; Ellens, Harma; Feng, Bo; Taub, Mitchell E; Paine, Mary F; Polli, Joseph W; Ware, Joseph A; Zamek-Gliszczynski, Maciej J

    2015-04-01

    Breast cancer resistance protein (BCRP; ABCG2) limits intestinal absorption of low-permeability substrate drugs and mediates biliary excretion of drugs and metabolites. Based on clinical evidence of BCRP-mediated drug-drug interactions (DDIs) and the c.421C>A functional polymorphism affecting drug efficacy and safety, both the US Food and Drug Administration and European Medicines Agency recommend preclinical evaluation and, when appropriate, clinical assessment of BCRP-mediated DDIs. Although many BCRP substrates and inhibitors have been identified in vitro, clinical translation has been confounded by overlap with other transporters and metabolic enzymes. Regulatory recommendations for BCRP-mediated clinical DDI studies are challenging, as consensus is lacking on the choice of the most robust and specific human BCRP substrates and inhibitors and optimal study design. This review proposes a path forward based on a comprehensive analysis of available data. Oral sulfasalazine (1000 mg, immediate-release tablet) is the best available clinical substrate for intestinal BCRP, oral rosuvastatin (20 mg) for both intestinal and hepatic BCRP, and intravenous rosuvastatin (4 mg) for hepatic BCRP. Oral curcumin (2000 mg) and lapatinib (250 mg) are the best available clinical BCRP inhibitors. To interrogate the worst-case clinical BCRP DDI scenario, study subjects harboring the BCRP c.421C/C reference genotype are recommended. In addition, if sulfasalazine is selected as the substrate, subjects having the rapid acetylator phenotype are recommended. In the case of rosuvastatin, subjects with the organic anion-transporting polypeptide 1B1 c.521T/T genotype are recommended, together with monitoring of rosuvastatin's cholesterol-lowering effect at baseline and DDI phase. A proof-of-concept clinical study is being planned by a collaborative consortium to evaluate the proposed BCRP DDI study design.

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

    PubMed

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

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

  7. Developing Medicare Competitive Bidding: A Study of Clinical Laboratories

    PubMed Central

    Hoerger, Thomas J.; Meadow, Ann

    1997-01-01

    Competitive bidding to derive Medicare fees promises several advantages over administered fee systems. The authors show how incentives for cost savings, quality, and access can be incorporated into bidding schemes, and they report on a study of the clinical laboratory industry conducted in preparation for a bidding demonstration. The laboratory industry is marked by variable concentration across geographic markets and, among firms themselves, by social and economic heterogeneity. The authors conclude that these conditions can be accommodated by available bidding design options and by careful selection of bidding markets. PMID:10180003

  8. Is there role of additional chemotherapy after definitive local treatment for stage I/II marginal zone lymphoma?: Consortium for Improving Survival of Lymphoma (CISL) study.

    PubMed

    Koh, Myeong Seok; Kim, Won Seog; Kim, Seok Jin; Oh, Sung Yong; Yoon, Dok Hyun; Lee, Soon Il; Hong, Junshik; Song, Moo Kon; Shin, Ho-Jin; Kwon, Jung Hye; Kim, Hyo Jung; Do, Yong Rok; Suh, Cheolwon; Kim, Hyo Jin

    2015-10-01

    Even though local stage (Ann Arbor stage I/II) marginal zone lymphoma (MZL) is well controlled with local treatment-based therapy, no data exist on the role of additional chemotherapy after local treatment for stage I/II MZL. Patients with biopsy-confirmed Ann Arbor stage I/II MZL (n = 210) were included for analysis in this study. Of these, 180 patients (85.7 %) were stage I and 30 (14.3 %) were stage II. Most patients (n = 182, 86.7 %) were treated with a local modality including radiation therapy or surgery and 28 (13.3 %) received additional systemic chemotherapy after local treatment. The overall response rate was 98.3 % (95 % CI 96-100 %), with 187 complete responses and 20 partial responses. In the local treatment group, the mean progression-free survival (PFS) was 147.4 months (95 % CI 126.7-168.1 months) and the overall survival (OS) was 188.2 months (95 % CI 178.8-197.7 months). In the additional chemotherapy group, the mean PFS was 103.4 months (95 % CI 84.9-121.9 months) and the OS was 137.3 months (95 % CI 127.9-146.7 months). There was no difference between the two groups in OS (p = 0.836) and PFS (p = 0.695). Local stage MZL has a good clinical course and is well controlled with a local treatment modality without additional chemotherapy.

  9. Multi-spectroscopic and molecular modeling studies of bovine serum albumin interaction with sodium acetate food additive.

    PubMed

    Mohammadzadeh-Aghdash, Hossein; Ezzati Nazhad Dolatabadi, Jafar; Dehghan, Parvin; Panahi-Azar, Vahid; Barzegar, Abolfazl

    2017-08-01

    Sodium acetate (SA) has been used as a highly effective protectant in food industry and the possible effect of this additive on the binding to albumin should be taken into consideration. Therefore, for the first time, the mechanism of SA interaction with bovine serum albumin (BSA) has been investigated by multi-spectroscopic and molecular modeling methods under physiological conditions. Stern-Volmer fluorescence quenching analysis showed an increase in the fluorescence intensity of BSA upon increasing the amounts of SA. The high affinity of SA to BSA was demonstrated by a binding constant value (1.09×10(3) at 310°K). The thermodynamic parameters indicated that hydrophobic binding plays a main role in the binding of SA to Albumin. Furthermore, the results of UV-vis spectra confirmed the interaction of this additive to BSA. In addition, molecular modeling study demonstrated that A binding sites of BSA play the main role in the interaction with acetate.

  10. A mechanistic study of manganese(iii) acetate-mediated phosphonyl group additions to [60]- and [70]-fullerenes: the oxidative-ion-transfer mechanism vs. free radical addition.

    PubMed

    Tumanskii, Boris L; Sabirov, Denis S; Lyakhovetsky, Yury I

    2016-11-14

    The phosphonylation of C60 with HP(O)(OAlk)2 and Mn(OAc)3·2H2O has been considered to occur via a free radical (FR) path involving intermediate radicals ˙P(O)(OAlk)2. The present study provides evidence in support of another mechanism for the reactions, oxidative-ion-transfer (OIT). The mechanism involves the change of an acetate group in Mn(OAc)3 for the phosphonate group and oxidation of C60 by the Mn(OAc)2P(O)(OAlk)2 formed to a pair: (C60˙(+), Mn(OAc)2P(O)(OAlk)2˙(-)) followed by the transfer of the phosphonate anion to give the monophposphonylfullerenyl radical. It undergoes reversible dimerization. The polyaddition occurs analogously. Moreover, the compounds Mn(OAc)2P(O)(OAlk)2 (Alk = Et and i-Pr) obtained make novel reagents for phosphonylation of fullerenes working by the OIT mechanism. The reactions of C60 in benzene with equimolar amounts of Mn(OAc)2P(O)(OPr-i)2 or Hg[P(O)(OPr-i)2]2 which is known as working by the FR mechanism since it produces radical ˙P(O)(OPr-i)2 under UV-irradiation, furnished the same radical ˙C60P(O)(OPr-i)2. However, at a 20-fold molar excess of the reagent toward C60, a single derivative C60[P(O)(OPr-i)2]4 and a mixture of derivatives bearing between two and eight phosphonyls were obtained in the former and latter cases, respectively. With C70, the change of the mechanism produced a change in the regioselectivity: 5 and 3 isomers of ˙C70P(O)(OPr-i)2 were obtained, respectively. DFT-calculations provided the hyperfine coupling (hfc) constants of the isomers and explained the regioselectivity change.

  11. Unravelling the impact of hydrocarbon structure on the fumarate addition mechanism--a gas-phase ab initio study.

    PubMed

    Bharadwaj, Vivek S; Vyas, Shubham; Villano, Stephanie M; Maupin, C Mark; Dean, Anthony M

    2015-02-14

    The fumarate addition reaction mechanism is central to the anaerobic biodegradation pathway of various hydrocarbons, both aromatic (e.g., toluene, ethyl benzene) and aliphatic (e.g., n-hexane, dodecane). Succinate synthase enzymes, which belong to the glycyl radical enzyme family, are the main facilitators of these biochemical reactions. The overall catalytic mechanism that converts hydrocarbons to a succinate molecule involves three steps: (1) initial H-abstraction from the hydrocarbon by the radical enzyme, (2) addition of the resulting hydrocarbon radical to fumarate, and (3) hydrogen abstraction by the addition product to regenerate the radical enzyme. Since the biodegradation of hydrocarbon fuels via the fumarate addition mechanism is linked to bio-corrosion, an improved understanding of this reaction is imperative to our efforts of predicting the susceptibility of proposed alternative fuels to biodegradation. An improved understanding of the fuel biodegradation process also has the potential to benefit bioremediation. In this study, we consider model aromatic (toluene) and aliphatic (butane) compounds to evaluate the impact of hydrocarbon structure on the energetics and kinetics of the fumarate addition mechanism by means of high level ab initio gas-phase calculations. We predict that the rate of toluene degradation is ∼100 times faster than butane at 298 K, and that the first abstraction step is kinetically significant for both hydrocarbons, which is consistent with deuterium isotope effect studies on toluene degradation. The detailed computations also show that the predicted stereo-chemical preference of the succinate products for both toluene and butane are due to the differences in the radical addition rate constants for the various isomers. The computational and kinetic modeling work presented here demonstrates the importance of considering pre-reaction and product complexes in order to accurately treat gas phase systems that involve intra and inter

  12. Enantioselective conjugate addition of nitro compounds to α,β-unsaturated ketones: an experimental and computational study.

    PubMed

    Manzano, Rubén; Andrés, José M; Álvarez, Rosana; Muruzábal, María D; de Lera, Ángel R; Pedrosa, Rafael

    2011-05-16

    A series of chiral thioureas derived from easily available diamines, prepared from α-amino acids, have been tested as catalysts in the enantioselective Michael additions of nitroalkanes to α,β-unsaturated ketones. The best results are obtained with the bifunctional catalyst prepared from L-valine. This thiourea promotes the reaction with high enantioselectivities and chemical yields for aryl/vinyl ketones, but the enantiomeric ratio for alkyl/vinyl derivatives is very modest. The addition of substituted nitromethanes led to the corresponding adducts with excellent enantioselectivity but very poor diastereoselectivity. Evidence for the isomerization of the addition products has been obtained from the reaction of chalcone with [D(3)]nitromethane, which shows that the final addition products epimerize under the reaction conditions. The epimerization explains the low diastereoselectivity observed in the formation of adducts with two adjacent tertiary stereocenters. Density functional studies of the transition structures corresponding to two alternative activation modes of the nitroalkanes and α,β-unsaturated ketones by the bifunctional organocatalyst have been carried out at the B3LYP/3-21G* level. The computations are consistent with a reaction model involving the Michael addition of the thiourea-activated nitronate to the ketone activated by the protonated amine of the organocatalyst. The enantioselectivities predicted by the computations are consistent with the experimental values obtained for aryl- and alkyl-substituted α,β-unsaturated ketones.

  13. Clinical study of cutaneous leishmaniasis in the Kashmir Valley

    PubMed Central

    Wani, Gh Mohiuddin; Ahmad, Sheikh Manzoor; Khursheed, Bilques

    2015-01-01

    Background: Cutaneous leishmaniasis (CL) is an infectious disease of tropical and semitropical areas of the world. The cold and harsh winter conditions of the Kashmir Valley do not favor the survival and growth of the Leishmania parasite or its vector, the sand fly, and the disease was until now practically unheard of in the Kashmir Valley. Aims: There has been a recent rise in the number of cases of CL in the Kashmir Valley. Against this background, the present study was taken up to describe the epidemiology, clinical features, and management outcomes of CL in the Kashmir Valley, where it represents a new phenomenon. Materials and Methods: Patients with direct smear-confirmed CL were evaluated. For each patient, we noted age, gender, geographical origin, stays in endemic areas, clinical aspects, number, site and size of lesions, treatment, and outcome. All the infected patients were treated with sodium stibogluconate. The dose, route of administration, adverse effects, and the clinical response in each patient was noted down. Results: Eighteen patients, 11 males (61.12%) and 7 females (38.88%) were studied. The age of the patients ranged from 3 to 60 years (mean age 29.8). The majority of our patients (16, 88.9%) belonged to two hilly areas, Uri and Karnah. Duration of the disease ranged from a minimum of 1 month to a maximum of 18 months (mean duration 4.6 months). Lesions in most of our patients (16, 88.9%) were located on the face including the lip and nose. The size of lesions varied from 4 to about 50 mm (average 2-3 cm). Most of our patients (13, 73.3%) had only a single lesion and a few (5, 26.7%) had two or three lesions. The clinical type of lesion in most of our patients (16, 88.9%) was noduloulcerative, only two (11.1%) had nodular (nonulcerative) lesions. Sixteen patients; all with facial lesions were treated with intravenous sodium stibogluconate. A complete response was seen in 14 (87%), without any major adverse effect. Two adult patients with

  14. A clinical and microbiological study on the enantiomers of delmopinol.

    PubMed

    Sjödin, Torgny; Nilner, Krister; Sparre, Birgitta; Bernet, Catarina; Åström, Mikael

    2016-07-01

    Objective The clinical part of this study aimed to investigate whether the racemate of delmopinol [(±)-delmopinol] is equivalent to its two enantiomers [(+)-delmopinol and (-)-delmopinol] with respect to efficiency and to determine and compare their pharmacokinetic properties. The purpose of the pre-clinical part was to elucidate possible differences in antimicrobial efficiency. Materials and methods The compounds were tested clinically in a double-blind, randomized, cross-over study comprising three treatment periods of 4 days each. The antimicrobial efficacy of the enantiomers was compared in vitro with respect to planktonic and biofilm bacteria of different species. Results No statistically significant differences in prevention of plaque formation were observed. Except for a somewhat higher systemic exposure in terms of AUC and Cmax indicated for (-)-delmopinol compared to (+)-delmopinol, the pharmacokinetic properties were similar. The most common adverse event was a transient anaesthetic feeling in the mouth. This event was reported with the same frequency for all three test solutions. The enantiomers showed similar antimicrobial effects on planktonic bacteria and their biofilms. Conclusions The enantiomers were found to be equally effective with respect to inhibition of plaque development and only minor differences were observed with respect to their pharmacokinetic properties. No differences could be observed in the adverse events reports. There is, therefore, no reason to use one of the enantiomers of delmopinol instead of the racemate. This was further supported by the antimicrobial tests. It is suggested that the combined action of cationic and neutral delmopinol is important for its effect on biofilms.

  15. Central odontogenic fibroma: Retrospective study of 8 clinical cases

    PubMed Central

    Hrichi, Radia; Gargallo-Albiol, Jordi; Berini-Aytés, Leonardo

    2012-01-01

    Introduction and Objectives: The central odontogenic fibroma (COF) is a benign odontogenic tumour derived from the dental mesenchymal tissues. It is a rare tumour and only 70 cases of it have been published. Bearing in mind the rareness of the tumour, 8 new cases of central odontogenic fibroma have been found by analyzing the clinical, radiological and histopathological characteristics of COF. Patients and Method: A retrospective study was carried out on 3011 biopsies in the Service of Oral and Maxillofacial Surgery of the Dental Clinic of Barcelona University between January 1995 and March 2008. 85 odontogenic tumours were diagnosed of which 8 were central odontogenic fibroma. The radiological study was based on orthopantomographs, periapical and occlusal radiographies and computerised tomographics. The variables collected were: sex, age, clinical characteristics of the lesion, treatment received and possible reappearances of the tumour. Results: The central odontogenic fibroma represents 9.4% of all odontogenic tumours. Of the 8 cases, 5 were diagnosed in men and 3 in women. The average age was 19.9 years with an age range of 11 to 38 years. The most common location of the tumour was in the mandible. All cases were associated with unerupted teeth. Of the 8 tumours, 3 provoked rhizolysis of the adjacent teeth and 4 cases caused cortical bone expansion. 50% of the patients complained of pain associated to the lesion. No case of recurrence was recorded up to 2 years after the treatment. Conclusions: Central odontogenic fibromas usually evolve asymptomatically although they can manifest very aggressively provoking dental displacement and rhizolysis. Radiologically, COF manifest as a uni or multilocular radiotransparent image although they can be indistinguishable from other radiotransparent lesions making diagnosis more difficult. COF treatment involves conservative surgery as well as follow-up patient checks. Key words: Odontogenic tumour, central odontogenic

  16. 3-methylcrotonyl-CoA carboxylase deficiency: Clinical, biochemical, enzymatic and molecular studies in 88 individuals

    PubMed Central

    2012-01-01

    Background Isolated 3-methylcrotonyl-CoA carboxylase (MCC) deficiency is an autosomal recessive disorder of leucine metabolism caused by mutations in MCCC1 or MCCC2 encoding the α and β subunit of MCC, respectively. The phenotype is highly variable ranging from acute neonatal onset with fatal outcome to asymptomatic adults. Methods We report clinical, biochemical, enzymatic and mutation data of 88 MCC deficient individuals, 53 identified by newborn screening, 26 diagnosed due to clinical symptoms or positive family history and 9 mothers, identified following the positive newborn screening result of their baby. Results Fifty-seven percent of patients were asymptomatic while 43% showed clinical symptoms, many of which were probably not related to MCC deficiency but due to ascertainment bias. However, 12 patients (5 of 53 identified by newborn screening) presented with acute metabolic decompensations. We identified 15 novel MCCC1 and 16 novel MCCC2 mutant alleles. Additionally, we report expression studies on 3 MCCC1 and 8 MCCC2 mutations and show an overview of all 132 MCCC1 and MCCC2 variants known to date. Conclusions Our data confirm that MCC deficiency, despite low penetrance, may lead to a severe clinical phenotype resembling classical organic acidurias. However, neither the genotype nor the biochemical phenotype is helpful in predicting the clinical course. PMID:22642865

  17. Lessons Learned from an ICD-10-CM Clinical Documentation Pilot Study

    PubMed Central

    Moczygemba, Jackie; Fenton, Susan H

    2012-01-01

    On October 1, 2013, the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) will be mandated for use in the United States in place of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). This new classification system will used throughout the nation's healthcare system for recording diagnoses or the reasons for treatment or care. A pilot study was conducted to determine whether current levels of inpatient clinical documentation provide the detail necessary to fully utilize the ICD-10-CM classification system for heart disease, pneumonia, and diabetes cases. The design of this pilot study was cross-sectional. Four hundred ninety-one de-identified records from two sources were coded using ICD-10-CM guidelines and codebooks. The findings of this study indicate that healthcare organizations need to assess clinical documentation and identify gaps. In addition, coder proficiency should be assessed prior to ICD-10-CM implementation to determine the need for further education and training in the biomedical sciences, along with training in the new classification system. PMID:22548021

  18. Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

    PubMed Central

    Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

    2009-01-01

    Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

  19. Does additional prenatal care in the home improve birth outcomes for women with a prior preterm delivery? A randomized clinical trial.

    PubMed

    Lutenbacher, Melanie; Gabbe, Patricia Temple; Karp, Sharon M; Dietrich, Mary S; Narrigan, Deborah; Carpenter, Lavenia; Walsh, William

    2014-07-01

    Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention. Home visitation is a promising method to deliver evidence based interventions. We evaluated a system of care designed to reduce preterm births and hospital length of stay in a sample of pregnant women with a history of a PTB. Single site randomized clinical trial. Eligibility: >18 years with prior live birth ≥20-<37 weeks gestation; <24 weeks gestation at enrollment; spoke and read English; received care at regional medical center. All participants (N = 211) received standard prenatal care. Intervention participants (N = 109) also received home visits by certified nurse-midwives guided by protocols for specific risk factors (e.g., depressive symptoms, abuse, smoking). Data was collected via multiple methods and sources including intervention fidelity assessments. Average age 27.8 years; mean gestational age at enrollment was 15 weeks. Racial breakdown mirrored local demographics. Most had a partner, high school education, and 62% had Medicaid. No statistically significant group differences were found in gestational age at birth. Intervention participants had a shorter intrapartum length of stay. Enhanced prenatal care by nurse-midwife home visits may limit some risk factors and shorten intrapartum length of stay for women with a prior PTB. This study contributes to knowledge about evidence-based home visit interventions directed at risk factors associated with PTB.

  20. A prospective clinical study of polycarboxylate cement in periapical surgery

    PubMed Central

    Ortega-Sánchez, Bárbara; García-Mira, Berta; Maestre-Ferrín, Laura; Peñarrocha-Oltra, David; Gay-Escoda, Cosme

    2012-01-01

    Objective: To evaluate the clinical efficacy of polycarboxylate cement as retrograde filling material. Design: A prospective clinical study was made of 25 patients subjected to periapical surgery with ultrasound and magnifying loupes, in which polycarboxylate cement was used as retrograde filling material. Measurements were made of the area and diameter of the lesions pre- and postoperatively, and 6 and 12 months after the operation. The apical resection and retrograde filling areas were also measured, and the prognosis following surgery was recorded. Results: A total of 23 patients with 31 apicoectomized teeth were studied (2 patients being lost to follow-up). The mean area of the periapical lesions before surgery was 52.25 mm2, with a mean major diameter of 6.1 mm and a mean lesser diameter of 4.8 mm. The success rate after 12 months was 54.7%, according to the criteria of Von Arx and Kurt. The prognosis was poorer in females, in larger lesions, and in cases with larger retrograde filling areas. Conclusions: Polycarboxylate cement offers good results, with important bone regeneration after periapical surgery. Key words: Periapical surgery, endodontic treatment, polycarboxylate cement. PMID:22143701

  1. Protein-bound uremic toxins: new insight from clinical studies.

    PubMed

    Liabeuf, Sophie; Drüeke, Tilman B; Massy, Ziad A

    2011-07-01

    The uremic syndrome is attributed to the progressive retention of a large number of compounds which, under normal conditions, are excreted by healthy kidneys. The compounds are called uremic toxins when they interact negatively with biological functions. The present review focuses on a specific class of molecules, namely the family of protein-bound uremic toxins. Recent experimental studies have shown that protein-bound toxins are involved not only in the progression of chronic kidney disease (CKD), but also in the generation and aggravation of cardiovascular disease. Two protein-bound uremic retention solutes, namely indoxyl sulfate and p-cresyl sulfate, have been shown to play a prominent role. However, although these two molecules belong to the same class of molecules, exert toxic effects on the cardiovascular system in experimental animals, and accumulate in the serum of patients with CKD they may have different clinical impacts in terms of cardiovascular disease and other complications. The principal aim of this review is to evaluate the effect of p-cresyl sulfate and indoxyl sulfate retention on CKD patient outcomes, based on recent clinical studies.

  2. A study of internal structure in components made by additive manufacturing process using 3 D X-ray tomography

    SciTech Connect

    Raguvarun, K. Balasubramaniam, Krishnan Rajagopal, Prabhu; Palanisamy, Suresh; Nagarajah, Romesh; Kapoor, Ajay; Hoye, Nicholas; Curiri, Dominic

    2015-03-31

    Additive manufacturing methods are gaining increasing popularity for rapidly and efficiently manufacturing parts and components in the industrial context, as well as for domestic applications. However, except when used for prototyping or rapid visualization of components, industries are concerned with the load carrying capacity and strength achievable by additive manufactured parts. In this paper, the wire-arc additive manufacturing (AM) process based on gas tungsten arc welding (GTAW) has been examined for the internal structure and constitution of components generated by the process. High-resolution 3D X-ray tomography is used to gain cut-views through wedge-shaped parts created using this GTAW additive manufacturing process with titanium alloy materials. In this work, two different control conditions for the GTAW process are considered. The studies reveal clusters of porosities, located in periodic spatial intervals along the sample cross-section. Such internal defects can have a detrimental effect on the strength of the resulting AM components, as shown in destructive testing studies. Closer examination of this phenomenon shows that defect clusters are preferentially located at GTAW traversal path intervals. These results highlight the strong need for enhanced control of process parameters in ensuring components with minimal defects and higher strength.

  3. The efficacy of pressure relief maneuvers in spinal cord injury patients, a clinical study

    NASA Astrophysics Data System (ADS)

    Ho, Thuan; Nguyen, Ahn Thu; Lichy, Alison; Groah, Suzanne; Ramella-Roman, Jessica C.

    2014-02-01

    Pressure reliefs are recommended to wheelchair bound individuals to control and minimize skin damage. To this date recommendation on duration and intervals between pressure reliefs is not clear. Recent studies have shown a relationship between reduction in tissue perfusion and oxygenation due to pressure and skin pathophysiologic changes. We have developed a fiber-optics probe that allows measurement of oxygenation in addition to perfusion in real time; this low profile probe can be utilized while sitting and during pressure reliefs. We have conducted a clinical trial at the National Rehabilitation Hospital on individual with spinal cord injury. The overriding goal of this project was to develop the evidence base for clinical recommendations on pressure reliefs. Results of the study will be presented.

  4. [Placebo response: in studies on pain and under other clinical conditions].

    PubMed

    Weimer, K; Horing, B; Klosterhalfen, S; Enck, P

    2011-06-01

    This contribution compares unexplained essential questions regarding the placebo response with current empirical evidence: (1) Are the placebo response rates equivalent in the groups treated with medication or placebo? Very little evidence has been gathered to support this generally accepted additivity while some findings negate its validity. (2) Is the placebo response a function of the probability of receiving medication or placebo? There are indications that the number of study groups included in a trial determines the level of placebo and medication response. (3) How great is the placebo response in trials that directly compare a (new) medication with one that for example is already on the market? There are indications that such comparative studies produce higher placebo response rates. (4) How high is the placebo response rate in everyday clinical practice--or does the response to a medication in trials substantiate the effect of the medication in everyday clinical practice?

  5. [How to share results of clinical trials with study participants?].

    PubMed

    Sarradon-Eck, Aline; Mancini, Julien; Genre, Dominique; Sakoyan, Juliette; Desclaux, Alice; Julian-Reynier, Claire

    2012-03-01

    Informing research participants of the results of clinical trials in which they were enrolled is in agreement with patients' rights and human dignity; such feedback is considered an ethical standard applied to clinical research. Cancer patients who participate in a clinical trial usually want to know the results. Here we analysed the literature about the different ways of disclosure of clinical trial results to participants, questioning their expectations and the meanings they give to the results. We describe some of the dilemma and intertwining between clinical care and clinical research. We highlight how the standardisation of sharing such results to participants could raise difficulties particularly for the relationship between doctor and patients.

  6. Fundamental and clinical studies on tumor control by TBI

    SciTech Connect

    Sakamoto, Kiyohiko; Myojin, Miyako

    1996-12-31

    Total body irradiation (TBI) has been considered to bring about immunosuppressive effects on organisms. The conclusion is derived from data obtained by sublethal doses of TBI, but there are no data on how low doses of TBI act on organisms. On the other hand, it is known that low doses of TBI are effective on some malignant lymphoma or chronic myelogenous leukemia. However, the effect of low doses of TBI is rarely investigated radiobiologically. For 15 yr, the authors have studied the effects of low doses of TBI on normal or tumor-bearing mice and its immunological background. In this paper, they show the results of fundamental and clinical studies on tumor control by low doses of TBI.

  7. Statins in oncological research: from experimental studies to clinical practice.

    PubMed

    Kubatka, Peter; Kruzliak, Peter; Rotrekl, Vladimir; Jelinkova, Sarka; Mladosievicova, Beata

    2014-12-01

    Statins, 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors are commonly used drugs in the treatment of dyslipidemias, primarily raised cholesterol. Recently, many epidemiological and preclinical studies pointed to anti-tumor properties of statins, including anti-proliferative activities, apoptosis, decreased angiogenesis and metastasis. These processes play an important role in carcinogenesis and, therefore, the role of statins in cancer disease is being seriously discussed among oncologists. Anti-neoplastic properties of statins combined with an acceptable toxicity profile in the majority of individuals support their further development as anti-tumor drugs. The mechanism of action, current preclinical studies and clinical efficacy of statins are reviewed in this paper. Moreover, promising results have been reported regarding the statins' efficacy in some cancer types, especially in esophageal and colorectal cancers, and hepatocellular carcinoma. Statins' hepatotoxicity has traditionally represented an obstacle to the prescription of this class of drugs and this issue is also discussed in this review.

  8. [Textile intolerance in atopic eczema--a controlled clinical study].

    PubMed

    Diepgen, T L; Stäbler, A; Hornstein, O P

    1990-10-01

    In patients suffering from atopic dermatitis (AD), we often find intolerance reactions against wool, whereas irritation by synthetic fibers is still a matter of discussion. In a randomized clinical study on 55 patients with AD and 31 healthy controls, we investigated the irritative capacity of poncho-like shirts made of 4 different materials (A: cotton; B, C, D: synthetics of different fiber structure). The intensity of itching or discomfort due to repeated wearing of these shirts was evaluated by means of a point system (max.comfort = 10 points, max. discomfort = 1 point). Our study clearly showed that the irritative capacity of synthetic shirts is significantly higher in patients with AD, while cotton shirts were best tolerated. We also observed significant difference regarding the surface structure and diameter of the synthetic fibers under investigation.

  9. 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...

  10. Clinical Study of Ursodeoxycholic Acid in Barrett's Esophagus Patients.

    PubMed

    Banerjee, Bhaskar; Shaheen, Nicholas J; Martinez, Jessica A; Hsu, Chiu-Hsieh; Trowers, Eugene; Gibson, Blake A; Della'Zanna, Gary; Richmond, Ellen; Chow, H-H Sherry

    2016-07-01

    Prior research strongly implicates gastric acid and bile acids, two major components of the gastroesophageal refluxate, in the development of Barrett's esophagus and its pathogenesis. Ursodeoxycholic acid (UDCA), a hydrophilic bile acid, has been shown to protect esophageal cells against oxidative stress induced by cytotoxic bile acids. We conducted a pilot clinical study to evaluate the clinical activity of UDCA in patients with Barrett's esophagus. Twenty-nine patients with Barrett's esophagus received UDCA treatment at a daily dose of 13 to 15 mg/kg/day for 6 months. The clinical activity of UDCA was assessed by evaluating changes in gastric bile acid composition and markers of oxidative DNA damage (8-hydroxydeoxyguanosine), cell proliferation (Ki67), and apoptosis (cleaved caspase-3) in Barrett's esophagus epithelium. The bile acid concentrations in gastric fluid were measured by liquid chromatography/mass spectrometry. At baseline, UDCA (sum of unchanged and glycine/taurine conjugates) accounted for 18.2% of total gastric bile acids. After UDCA intervention, UDCA increased significantly to account for 93.4% of total gastric bile acids (P < 0.0001). The expression of markers of oxidative DNA damage, cell proliferation, and apoptosis was assessed in the Barrett's esophagus biopsies by IHC. The selected tissue biomarkers were unchanged after 6 months of UDCA intervention. We conclude that high-dose UDCA supplementation for 6 months resulted in favorable changes in gastric bile acid composition but did not modulate selected markers of oxidative DNA damage, cell proliferation, and apoptosis in the Barrett's esophagus epithelium. Cancer Prev Res; 9(7); 528-33. ©2016 AACRSee related article by Brian J. Reid, p. 512.

  11. Clinical and genetic study of hereditary spastic paraplegia in Canada

    PubMed Central

    Chrestian, Nicolas; Dupré, Nicolas; Gan-Or, Ziv; Szuto, Anna; Chen, Shiyi; Venkitachalam, Anil; Brisson, Jean-Denis; Warman-Chardon, Jodi; Ahmed, Sohnee; Ashtiani, Setareh; MacDonald, Heather; Mohsin, Noreen; Mourabit-Amari, Karim; Provencher, Pierre; Boycott, Kym M.; Stavropoulos, Dimitri J.; Dion, Patrick A.; Ray, Peter N.; Suchowersky, Oksana; Rouleau, Guy A.

    2016-01-01

    Objective: To describe the clinical, genetic, and epidemiologic features of hereditary spastic paraplegia (HSP) in Canada and to determine which clinical, radiologic, and genetic factors determine functional outcomes for patients with HSP. Methods: We conducted a multicenter observational study of patients who met clinical criteria for the diagnosis of HSP in the provinces of Alberta, Ontario, and Quebec from 2012 to 2015. Characteristics of the participants were analyzed using descriptive statistics. The main outcome measure for a subset of the cohort (n = 48) was the Spastic Paraplegia Rating Scale. We also used the SPATAX-EUROSPA disability stage (disability score) to assess disability (n = 65). Results: A total of 526 patients were identified with HSP across the country, and 150 patients had a confirmed genetic diagnosis. Mutations were identified in 15 different genes; the most common were SPAST (SPG4, 48%), ATL1 (SPG3A, 16%), SPG11 (8%), SPG7 (7%), and KIAA0196 (SPG8, 5%). The diagnosis of SPG4 was associated with older age at symptom onset (p = 0.0017). SPG4 and SPG3A were less associated with learning disabilities compared to other subtypes of HSP, and SPG11 was strongly associated with progressive cognitive deficits (odds ratio 87.75, 95% confidence interval 14.04–548.24, p < 0.0001). SPG3A was associated with better functional outcomes compared to other HSP subtypes (p = 0.04) on multivariate analysis. The strongest predictor of significant disability was abnormal brain MRI (p = 0.014). Conclusions: The most important predictors of disability in our HSP cohort were SPG11 mutations and abnormal brain MRI. Accurate molecular characterization of well-phenotyped cohorts and international collaboration are essential to establish the natural history of these rare neurodegenerative disorders. PMID:27957547

  12. Bacterial keratitis: a prospective clinical and microbiological study

    PubMed Central

    Schaefer, F.; Bruttin, O.; Zografos, L.; Guex-Crosier, Y.

    2001-01-01

    AIM—To define the clinical and microbiological profile of bacterial keratitis at the Jules Gonin Eye Hospital and to test the in vitro bacterial resistance.
METHODS—Patients presenting with bacterial keratitis were prospectively followed; clinical features (age, risk factors, visual acuity) and response to therapy were analysed. Bacteriological profile was determined and the sensitivity/resistance of isolated strains were tested towards 12 ocular antibiotics (NCCLS disc diffusion test).
RESULTS—85 consecutive patients (mean age 44.3 (SD 20.7) years) were prospectively enrolled from 1 March 1997 to 30 November 1998. The following risk factors were identified: contact lens wear, 36%; blepharitis, 21%; trauma, 20%; xerophthalmia, 15%; keratopathies, 8%; and eyelid abnormalities, 6%. The most commonly isolated bacteria were Staphylococcus epidermidis, 40%; Staphylococcus aureus, 22%; Streptococcus pneumoniae, 8%; others Streptococcus species, 5%; Pseudomonas, 9%; Moraxella and Serratia marcescens, 5% each; Bacillus, Corynebacterium, Alcaligenes xyloxidans, Morganella morganii, and Haemophilus influenza, 1% each. 1-15% of strains were resistant to fluoroquinolones, 13-22% to aminoglycosides, 37% to cefazolin, 18% to chloramphenicol, 54% to polymyxin B, 51% to fusidic acid, and 45% to bacitracin. Five of the 85 patients (5.8%) had a poor clinical outcome with a visual loss of one or more lines of visual acuity.
CONCLUSION—Fluoroquinolones appear to be the therapy of choice for bacterial keratitis, but, based upon these in vitro studies, some strains may be resistant.

 PMID:11423460

  13. Potlining Additives

    SciTech Connect

    Rudolf Keller

    2004-08-10

    In this project, a concept to improve the performance of aluminum production cells by introducing potlining additives was examined and tested. Boron oxide was added to cathode blocks, and titanium was dissolved in the metal pool; this resulted in the formation of titanium diboride and caused the molten aluminum to wet the carbonaceous cathode surface. Such wetting reportedly leads to operational improvements and extended cell life. In addition, boron oxide suppresses cyanide formation. This final report presents and discusses the results of this project. Substantial economic benefits for the practical implementation of the technology are projected, especially for modern cells with graphitized blocks. For example, with an energy savings of about 5% and an increase in pot life from 1500 to 2500 days, a cost savings of $ 0.023 per pound of aluminum produced is projected for a 200 kA pot.

  14. Phosphazene additives

    DOEpatents

    Harrup, Mason K; Rollins, Harry W

    2013-11-26

    An additive comprising a phosphazene compound that has at least two reactive functional groups and at least one capping functional group bonded to phosphorus atoms of the phosphazene compound. One of the at least two reactive functional groups is configured to react with cellulose and the other of the at least two reactive functional groups is configured to react with a resin, such as an amine resin of a polycarboxylic acid resin. The at least one capping functional group is selected from the group consisting of a short chain ether group, an alkoxy group, or an aryloxy group. Also disclosed are an additive-resin admixture, a method of treating a wood product, and a wood product.

  15. Diagnostic potential of optical coherence tomography in non-melanoma skin cancer: a clinical study

    NASA Astrophysics Data System (ADS)

    Mogensen, Mette; Thrane, Lars; Jørgensen, Thomas Martini; Jemec, Gregor B. E.

    2007-07-01

    Introduction: Non-melanoma skin cancer (NMSC) is the most prevalent cancer in the Western World. OCT has proved potential in assisting clinical diagnosis and perhaps reducing the need for biopsies in NMSC. As non-invasive treatment is increasingly used for NMSC patients with superficial lesions, the development of non-invasive diagnostic technologies is highly relevant. Methods: The aim of this cross-sectional clinical study, enrolling 100 NMSC patients and 20 healthy volunteers, is to investigate the diagnostic accuracy and applicability of OCT in NMSC diagnosis. Our OCT-system has been developed at Risoe National Laboratory, Denmark and offers ppolarization sensitive-OCT (PS-OCT) that may have additional advantaged as NMSC differ in content of birefringent collagens from normal skin. Results: Basal cell carcinomas (BCC) can in some cases be distinguished from normal skin in OCT-images, as normal skin exhibits a layered structure this layering is not present in BCC and sometimes not in actinic keratosis (AK). BCC lesions seem to be clearly less reflective than normal tissue. The predictive value of OCT in NMSC will be presented from a clinical point of view. Discussion: The earlier a skin cancer is diagnosed, the better the prognosis. Estimation of diagnostic accuracy and abilities of OCT in clinical studies of skin cancer patients is essential to establish the role and future set-ups for diagnostic OCT-systems.

  16. Recommended practices for computerized clinical decision support and knowledge management in community settings: a qualitative study

    PubMed Central

    2012-01-01

    Background The purpose of this study was to identify recommended practices for computerized clinical decision support (CDS) development and implementation and for knowledge management (KM) processes in ambulatory clinics and community hospitals using commercial or locally developed systems in the U.S. Methods Guided by the Multiple Perspectives Framework, the authors conducted ethnographic field studies at two community hospitals and five ambulatory clinic organizations across the U.S. Using a Rapid Assessment Process, a multidisciplinary research team: gathered preliminary assessment data; conducted on-site interviews, observations, and field surveys; analyzed data using both template and grounded methods; and developed universal themes. A panel of experts produced recommended practices. Results The team identified ten themes related to CDS and KM. These include: 1) workflow; 2) knowledge management; 3) data as a foundation for CDS; 4) user computer interaction; 5) measurement and metrics; 6) governance; 7) translation for collaboration; 8) the meaning of CDS; 9) roles of special, essential people; and 10) communication, training, and support. Experts developed recommendations about each theme. The original Multiple Perspectives framework was modified to make explicit a new theoretical construct, that of Translational Interaction. Conclusions These ten themes represent areas that need attention if a clinic or community hospital plans to implement and successfully utilize CDS. In addition, they have implications for workforce education, research, and national-level policy development. The Translational Interaction construct could guide future applied informatics research endeavors. PMID:22333210

  17. Choosing the Correct AED: From Animal Studies to the Clinic

    PubMed Central

    Holmes, Gregory L.; Zhao, Qian

    2009-01-01

    Epilepsy is a chronic condition caused by an imbalance of normal excitatory and inhibitory forces in the brain. Antiepileptic drug therapy has been directed primarily toward reducing excitability through blockage of voltage-gated Na+ or Ca2+ channels, or increasing inhibition through enhancement of γ-aminobutyric acid currents. Prior to clinical studies, putative antiepileptic drugs are screened in animals, usually rodents. Maximal electrical shock, pentylenetetrazol, and kindling are typically used as non-mechanistic screens for antiseizure properties and the rotorod test for assessing acute toxicity. While antiseizure drug screening has been successful in bringing drugs to the market and improving our understanding of the pathophysiology of seizures, it should be emphasized that the vast majority of drug screening occurs in mature male rodents and involves models of seizures, not epilepsy. Effective drugs in acute seizures may not be effective in chronic models of epilepsy. Seizure type, clinical and electroencephalographic phenotype, syndrome, and etiology are often quite different in children with epilepsy than adults. Despite these age-related unique features, drugs used in children are generally the same as used in adults. As awareness of the unique features of seizures during development increases, it is anticipated that more drug screening in the immature animal will occur. PMID:18279749

  18. Black tea: Phytochemicals, cancer chemoprevention, and clinical studies.

    PubMed

    Singh, Brahma N; Rawat, A K S; Bhagat, R M; Singh, B R

    2017-05-03

    Tea (Camellia sinensis L.) is the most popular, flavored, functional, and therapeutic non-alcoholic drink consumed by two-thirds of the world's population. Black tea leaves are reported to contain thousands of bioactive constituents such as polyphenols, amino acids, volatile compounds, and alkaloids that exhibit a range of promising pharmacological properties. Due to strong antioxidant property, black tea inhibits the development of various cancers by regulating oxidative damage of biomolecules, endogenous antioxidants, and pathways of mutagen and transcription of antioxidant gene pool. Regular drinking of phytochemicals-rich black tea is linked to regulate several molecular targets, including COX-2, 5-LOX, AP-1, JNK, STAT, EGFR, AKT, Bcl2, NF-κB, Bcl-xL, caspases, p53, FOXO1, TNFα, PARP, and MAPK, which may be the basis of how dose of black tea prevents and cures cancer. In vitro and preclinical studies support the anti-cancer activity of black tea; however, its effect in human trails is uncertain, although more clinical experiments are needed at molecular levels to understand its anti-cancer property. This review discusses the current knowledge on phytochemistry, chemopreventive activity, and clinical applications of black tea to reveal its anti-cancer effect.

  19. Repeating tests: different roles in research studies and clinical medicine.

    PubMed

    Monach, Paul A

    2012-10-01

    Researchers often decide whether to average multiple results in order to produce more precise data, and clinicians often decide whether to repeat a laboratory test in order to confirm its validity or to follow a trend. Some of the major sources of variation in laboratory tests (analytical imprecision, within-subject biological variation and between-subject variation) and the effects of averaging multiple results from the same sample or from the same person over time are discussed quantitatively in this article. This analysis leads to the surprising conclusion that the strategy of averaging multiple results is only necessary and effective in a limited range of research studies. In clinical practice, it may be important to repeat a test in order to eliminate the possibility of a rare type of error that has nothing to do analytical imprecision or within-subject variation, and for this reason, paradoxically, it may be most important to repeat tests with the highest sensitivity and/or specificity (i.e., ones that are critical for clinical decision-making).

  20. Clinical TVA-based studies: a general review

    PubMed Central

    Habekost, Thomas

    2015-01-01

    In combination with whole report and partial report tasks, the theory of visual attention (TVA) can be used to estimate individual differences in five basic attentional parameters: the visual processing speed, the storage capacity of visual short-term memory, the perceptual threshold, the efficiency of top–down selectivity, and the spatial bias of attentional weighting. TVA-based assessment has been used in about 30 studies to investigate attentional deficits in a range of neurological and psychiatric conditions: (a) neglect and simultanagnosia, (b) reading disturbances, (c) aging and neurodegenerative diseases, and most recently (d) neurodevelopmental disorders. The article introduces TVA based assessment, discusses its methodology and psychometric properties, and reviews the progress made in each of the four research fields. The empirical results demonstrate the general usefulness of TVA-based assessment for many types of clinical neuropsychological research. The method’s most important qualities are cognitive specificity and theoretical grounding, but it is also characterized by good reliability and sensitivity to minor deficits. The review concludes by pointing to promising new areas for clinical TVA-based research. PMID:25852607

  1. Erythroderma: A clinical-etiological study of 82 cases.

    PubMed

    Yuan, Xiao-Ying; Guo, Jian-You; Dang, Yu-Ping; Qiao, Li; Liu, Wei

    2010-01-01

    Erythroderma is an uncommon skin disorder characterized by generalized reddening and scaling of over 90% of the skin. It represents a maximal stage of skin irritation induced by several skin diseases such as psoriasis, contact dermatitis, drug reactions, and mycosis fungoides. Data including the clinical symptoms, laboratory examinations and skin biopsies were collected from 82 erythroderma patients admitted to our hospital in the period between Jan.1st, 2003 and Dec.31st, 2008. According to clinical findings, laboratory findings and biopsy results, the most common causative factors were pre-existing dermatoses (72.0%), followed by drug reactions (17.0%), idiopathic causes (6.1%) and malignancies (4.9%). Among the pre-existing dermatoses, psoriasis is the most common etiology (30.5%). We also found hypereosinophilic syndrome, sarcoidosis and dermatomyositis could be causes of erythroderma. In the drug-induced group, Chinese traditional herbal medicines were probably the most frequently implicated drugs in our series, with 9 of the 14 cases (64.3%). Follow-up information was obtained for 65 patients, and most of our patients had improved symptoms after treatment. In our series we found a high percentage of erythroderma secondary to pre-existing dermatoses and a low percentage of erythroderma secondary to malignancy. Among drugs as an etiological group, Chinese traditional herbal medicines were the most frequent drugs. From our follow-up study, the prognosis of most patients with erythroderma is relatively good.

  2. Concomitant otomycosis and dermatomycoses: a clinical and microbiological study.

    PubMed

    Ozcan, Muge; Ozcan, K Murat; Karaarslan, Aydin; Karaarslan, Filiz

    2003-01-01

    Otomycosis tends to recur despite long-term treatment. To our knowledge, there is no study in the English literature concerning the clinical importance of concomitant otomycosis and dermatomycoses. We investigated the presence of dermatomycoses in 52 patients with otomycosis in order to document the clinical and microbiological importance of their coexistence. Dermatomycoses on the feet and/or hands were identified in 19 patients (36.5%). The most common pathogen for otomycosis was Aspergillus niger, while it was Candida albicans for the dermatomycoses. The same pathogenic fungi were isolated from the otomycosis and dermatomycoses in nine of the 19 patients (47.4%). Aspergillus niger was the most common shared pathogen. The pathogens isolated in concomitant dermatomycoses were common pathogens for the fungal infection of the ear ( Aspergillus niger, Aspergillus flavus, Aspergillus fumigatus, Candida albicans). It was concluded that the autoinoculation of the ear canal by pathogenic fungi might be possible in the presence of the untreated dermatomycoses. Dermatomycoses must be investigated in patients with otomycosis and must be treated simultaneously in order to prevent the recurrence of both.

  3. Clinical and parasitological study on scabies in Sirte, Libya.

    PubMed

    Fathy, Fouad M; El-Kasah, Fathi; El-Ahwal, Abdulla M

    2010-12-01

    The present work aimed to determine the risk factors, clinical and parasitological skin lesion features and effective drug regimens. Study was carried out on 200 patients referred to dermatology outpatient clinics in Sirte-Libya. Each was subjected to detailed questionnaire, dermatological skin examination, parasitological skin scraping test (SST), burrow ink test (BIT), drug administration and follow up. Results revealed that females 59%, children 37.5% and military personnel 18% of immigrant families were particularly prone to scabies infestation. Effective risk factors included overcrowding, bed sharing, low hygienic and education levels. Commonest skin lesions included erythematous papules 93%, excoriated papules 77.5%, burrows 66%, pustulation 31%, vesicles 21.5 and nodules 3%. Predilection lesion sites were hand 86%, wrist 82%, abdomen 56%, male external genitalia 64.5% and female breast 28%. Specific SST was positive in 67.3% of cases, particularly sensitive in early cases with short itching duration. BIT was positive in 62%. Topical permethrin proved more effective than precipitated sulpher with cure rates of of 100% and 85.3% in 21% and 75% of cases, respectively. Ivermectin was 100% effective in 4% of cases.

  4. Palmoplantar Dermatoses- A Clinical Study of 300 Cases

    PubMed Central

    Rajashekhar, Nadiga; Gejje, Somashekar

    2016-01-01

    Introduction Dermatoses affecting palms and soles are among the most difficult of all dermatological therapeutic problems. Many previous studies have focused on the specific diseases of palmoplantar dermatoses. However, none of them have included a comprehensive study of palmoplantar dermatoses. Aims: To study the epidemiological aspects like age distribution, sex distribution, the dermatoses affecting the palms & soles and the frequency of involvement of palms, soles or both palms & soles, in patient with palmoplantar dermatoses. Materials and Methods This cross sectional study was conducted in the Department of Dermatology between October 2011 to September 2013. First 300 cases attending the department of dermatology primarily with complaints pertaining to palms and soles were enrolled in the study. After taking consent a detailed history and clinical examination pertaining to the aim of the study was recorded and analysed, which included inspection of morphology and distribution of lesions and palpation of any swelling. Direct microscopic examination of scrapings, wet mounted with 10% potassium hydroxide was done for cases with scaly lesions. Those who had a pustule, gram staining was done. Patch testing using Indian Standard Battery Series was done for those cases of eczema. A sample for biopsy was taken when diagnosis could not be arrived clinically, and subjected to histopathological examination. Results In our study of 300 patients with palmoplantar dermatoses, 164 were females and 136 were males, the ratio observed being 1.2:1. The peak incidence was found in the age group 21-30 years, with 41 females (25%) and 35 males (25.7%). Most frequently affected individuals in this study were housewives (30%). The most common five diseases of palmoplantar dermatoses were palmoplantar psoriasis (20.7%), moniliasis (19%), palmoplantar hyperhidrosis (7%), keratolysis exfoliativa (6%) and pitted keratolysis (6%). Majority of patients had involvement of both palms and

  5. Microstructural Development and Technical Challenges in Laser Additive Manufacturing: Case Study with a 316L Industrial Part

    NASA Astrophysics Data System (ADS)

    Marya, Manuel; Singh, Virendra; Marya, Surendar; Hascoet, Jean Yves

    2015-08-01

    Additive manufacturing (AM) brings disruptive changes to the ways parts, and products are designed, fabricated, tested, qualified, inspected, marketed, and sold. These changes introduce novel technical challenges and concerns arising from the maturity and diversity of today's AM processes, feedstock materials, and process parameter interactions. AM bears a resemblance with laser and electron beam welding in the so-called conduction mode, which involves a multitude of dynamic physical events between the projected feedstock and a moving heat source that eventually influence AM part properties. For this paper, an air vent was selected for its thin-walled, hollow, and variable cross section, and limited size. The studied air vents, randomly selected from a qualification batch, were fabricated out of 316L stainless steel using a 4 kW fiber laser powder-fed AM system, referred to as construction laser additive direct (CLAD). These were systematically characterized by microhardness indentation, visual examination, optical and scanning electron microscopy, and electron-back-scattering diffraction in order to determine AM part suitability for service and also broadly discuss metallurgical phenomena. The paper then briefly expands the discussion to include additional engineering alloys and further analyze relationships between AM process parameters and AM part properties, consistently utilizing past experience with the same powder-fed CLAD 3D printer, the well-established science and technology of welding and joining, and recent publications on additive manufacturing.

  6. The cardiovascular polypill: clinical data and ongoing studies.

    PubMed

    Castellano, José M; Bueno, Héctor; Fuster, Valentín

    2015-12-01

    Cardiovascular risk modification in terms of comprehensive medical therapy (antithrombotic therapy, lipid-lowering therapy, antihypertensive medication) and lifestyle modification (healthy diet, regular exercise, weight loss, smoking cessation) is the cornerstone of secondary prevention. It is now clear that even in those undergoing PCI or bypass surgery, appropriate lifestyle modification and aggressive medical therapy are paramount for optimizing long-term outcomes. However, what has emerged from studies that examined the role of medical therapy in the context of coronary heart disease is that only ∼50% of the patients in these studies are achieving target treatment goals for blood pressure, lipid and glycemic control. Non-adherence is thought to be a very large contributor to this problem; across all health-care categories, non-adherence is estimated to account for $290 billion of annual health-care expenditure in the United States and €1.25 billion in European Union, with poor adherence to CVD medication accounting for 9% of all European CVD events. Socioeconomic factors may have a role in patients' discontinuing their medications, and a major initiative to combat this problem is the increasing focus on the polypill. The idea of combining numerous medications into a single tablet to reduce CV risk was first proposed more than a decade ago. This combined formulation not only significantly enhances patient convenience and adherence but also drives savings for the healthcare systems. Several randomized clinical trials have consistently demonstrated the effects of polypills on CV risk factors and adherence, and major trials are underway to study the effect on hard clinical outcomes.

  7. Clinical and Dermoscopic Study of Pseudofolliculitis of the Beard Area

    PubMed Central

    Kaliyadan, Feroze; Kuruvilla, Joel; Al Ojail, Heba Yousef; Quadri, Sayed A

    2016-01-01

    Background: Pseudofolliculitis of the beard area is a very common dermatological problem in our geographical region. This could be partly because of the racial predilection as a large percentage of the population has curly hair and also may be due to local cultural customs, unlike the west do not encourage daily shaving of facial hair. Objectives: We aimed to mainly study the dermoscopic features of cases presenting with pseudofolliculitis. Secondary objectives included evaluating clinical patterns and possible etiological factors. Methods: Twenty-four consecutive male patients presenting to a University Health Center with a clinical diagnosis of pseudofolliculitis involving beard area were included in the study. Patient history with regards to shaving habits, patient hair type, morphological patterns of the skin lesions, and dermoscopic findings were recorded. Results: Majority of the patients had “curly” hair. Most of the patients had a usual shaving frequency of 2 or less per week. All the patients who were using razors mentioned that they tended to stretch the skin while shaving. The most common dermoscopic findings included - “Handle bar” sign showing curved hair attached to the skin on both ends, white areas indicate fibrosis and scaling, underlying linear bluish pigmentation (indicating the buried hair shaft), and linear vessels with occasional areas of hemorrhage. Conclusion: Dermoscopy can be a useful adjunct for diagnosis and patient counseling in pseudofolliculitis. Stretching the skin while using razors and growing the facial hair to a point where it has the length to curve might be important risk factors in the development of pseudofolliculitis. Limitations: The lack of histopathological correlation is the main limitation in our study. PMID:27127378

  8. An open multicenter comparative randomized clinical study on chitosan.

    PubMed

    Mo, Xiaohui; Cen, John; Gibson, Elaine; Wang, Robin; Percival, Steven L

    2015-01-01

    Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next-generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management

  9. Clinical study of 459 polydactyly cases in China, 2010 to 2014.

    PubMed

    Xiang, Ying; Bian, Jingxia; Wang, Zhigang; Xu, Yunlan; Fu, Qihua

    2016-09-01

    Polydactyly is one of the most common hereditary limb malformations, involving additional digits on the hands and/or feet, which is a very attractive model to appreciate clinical and genetic heterogeneity. A high level of heterogeneity in polydactyly has been identified in different regions. However, such data of the medical literatures for Asian populations are relatively limited. This study was intended to shed light on the phenotypic manifestations of polydactyly in the recruited Chinese population and to characterize the medical literature on this condition. A total of 459 well-characterized polydactyly cases from Shanghai Children's Medical Center were recruited. Their phenotypes, inheritance patterns, and clinical heterogeneity were obtained from clinical medical records. It was found that 4.8% of cases were familial and 95.2% were sporadic. The proportions of preaxial and postaxial polydactyly types were 74.7% and 25.3%, respectively. In preaxial polydactyly, type I formed the overwhelming majority (95.9%). Among the postaxial polydactyly cases, type A was most prevalent at 69.8% and type B was witnessed in 30.2% of cases. Familial and sporadic polydactyly patients mainly had unilateral presentations. A total of 583 limbs with additional digits were recorded in the 459 subjects. Upper limb involvement was more common than lower, and right hand involvement was more common than left for preaxial polydactyly, and lower limb involvement was more common than upper in postaxial polydactyly. This cohort added useful clinical/epidemiological information to the polydactyly literature in the Chinese population and highlighted its marked clinical heterogeneity.

  10. St. Lawrence Seaway N.Y. Feasibility Study for Additional Locks and Other Navigation Improvements: Plan of Study. Revision.

    DTIC Science & Technology

    1979-11-01

    throughout has increased. The shift to larger vessels, laker and ocean, has been faster than the rate of growth in tonnage demand for carriage. Various studies...Conditions Navigation Season 15 April to 15 December (1) (Thousands of Short Tons) :Annual * : Rate of * * *: Growth Commodity :: 1980- Group :1980 1990...December (1) (Thousands of Short Tons) * . * *:Annual * * * *: Rate of *: Growth Commodity : *: 1980- Group :1980 :1990 :2000 :2010 :2020 :2030 : 2030

  11. A quantum chemical study of the mechanisms of olefin addition to group 9 transition metal dioxo compounds.

    PubMed

    Ahmed, Issahaku; Tia, Richard; Adei, Evans

    2016-01-01

    triplet PES than on the singlet PES for the formation of similar analogues. There are fewer competitive reaction pathways on the triplet surface than on the singlet PES. Also, cycloadditions that seem impossible on the singlet PES seem possible on the doublet and or triplet PESs, this is the case typically for the Rh and Co complexes, illustrating the importance of multiple spin states in organometallic reactions.Graphical AbstractTable of Contents Synopsis: A study of the mechanism of ethylene addition to MO2(CH2)(CH3)(M=Co,Rh,Ir) shows the reactions of the Co complex have lower activation barriers for the preferred [3+2] and [2+2] addition pathways and fewer side reactions than those of Rh and Ir. Reactions are more feasible and selective on the triplet PES than on the singlet PES. These illustrate the importance of multiple spin states in organometallic reactions and shows catalyst activity and selectivity decreases down the group.

  12. A fundamental study of the oxidation behavior of SI primary reference fuels with propionaldehyde and DTBP as an additive

    NASA Astrophysics Data System (ADS)

    Johnson, Rodney

    In an effort to combine the benefits of SI and CI engines, Homogeneous Charge Compression Ignition (HCCI) engines are being developed. HCCI combustion is achieved by controlling the temperature, pressure, and composition of the fuel and air mixture so that autoignition occurs in proper phasing with the piston motion. This control system is fundamentally more challenging than using a spark plug or fuel injector to determine ignition timing as in SI and CI engines, respectively. As a result, this is a technical barrier that must be overcome to make HCCI engines applicable to a wide range of vehicles and viable for high volume production. One way to tailor the autoignition timing is to use small amounts of ignition enhancing additives. In this study, the effect of the addition of DTBP and propionaldehyde on the autoignition behavior of SI primary reference fuels was investigated. The present work was conducted in a new research facility built around a single cylinder Cooperative Fuels Research (CFR) octane rating engine but modified to run in HCCI mode. It focused on the effect of select oxygenated hydrocarbons on hydrocarbon fuel oxidation, specifically, the primary reference fuels n-heptane and iso-octane. This work was conducted under HCCI operating conditions. Previously, the operating parameters for this engine were validated for stable combustion under a wide range of operating parameters such as engine speeds, equivalence ratios, compression ratios and inlet manifold temperature. The stable operating range under these conditions was recorded and used for the present study. The major focus of this study was to examine the effect of the addition of DTBP or propionaldehyde on the oxidation behavior of SI primary reference fuels. Under every test condition the addition of the additives DTBP and propionaldehyde caused a change in fuel oxidation. DTBP always promoted fuel oxidation while propionaldehyde promoted oxidation for lower octane number fuels and delayed

  13. The Effect of Emphasizing Mathematical Structure in the Acquisition of Whole Number Computation Skills (Addition and Subtraction) By Seven- and Eight-Year Olds: A Clinical Investigation.

    ERIC Educational Resources Information Center

    Uprichard, A. Edward; Collura, Carolyn

    This investigation sought to determine the effect of emphasizing mathematical structure in the acquisition of computational skills by seven- and eight-year-olds. The meaningful development-of-structure approach emphasized closure, commutativity, associativity, and the identity element of addition; the inverse relationship between addition and…

  14. Applicability of the DPPH assay for evaluating the antioxidant capacity of food additives - inter-laboratory evaluation study -.

    PubMed

    Shimamura, Tomoko; Sumikura, Yoshihiro; Yamazaki, Takeshi; Tada, Atsuko; Kashiwagi, Takehiro; Ishikawa, Hiroya; Matsui, Toshiro; Sugimoto, Naoki; Akiyama, Hiroshi; Ukeda, Hiroyuki

    2014-01-01

    An inter-laboratory evaluation study was conducted in order to evaluate the antioxidant capacity of food additives by using a 1,1-diphenyl-2-picrylhydrazyl (DPPH) assay. Four antioxidants used as existing food additives (i.e., tea extract, grape seed extract, enju extract, and d-α-tocopherol) and 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid (Trolox) were used as analytical samples, and 14 laboratories participated in this study. The repeatability relative standard deviation (RSD(r)) of the IC50 of Trolox, four antioxidants, and the Trolox equivalent antioxidant capacity (TEAC) were 1.8-2.2%, 2.2-2.9%, and 2.1-2.5%, respectively. Thus, the proposed DPPH assay showed good performance within the same laboratory. The reproducibility relative standard deviation (RSD(R)) of IC50 of Trolox, four antioxidants, and TEAC were 4.0-7.9%, 6.0-11%, and 3.7-9.3%, respectively. The RSD(R)/RSD(r) values of TEAC were lower than, or nearly equal to, those of IC50 of the four antioxidants, suggesting that the use of TEAC was effective for reducing the variance among the laboratories. These results showed that the proposed DPPH assay could be used as a standard method to evaluate the antioxidant capacity of food additives.

  15. Clinical effect of addition of beraprost sodium to pioglitazone treatment on the blood glucose levels in patients with type 2 diabetes mellitus.

    PubMed

    Chen, T; Kusunoki, M; Sato, D; Tsutsui, H; Nakamura, T; Miyata, T; Oshida, Y

    2013-11-01

    In recent years, the number of patients with type 2 diabetes mellitus caused by insulin resistance has continued to increase in Japan. Insulin resistance is considered to be closely related to the risk of cardiovascular diseases and atherosclerotic diseases, represented by arteriosclerosis obliterans (ASO). Therefore, improvement of insulin resistance is one of the important strategies in the treatment of type 2 diabetes mellitus. At present, α-glucosidase inhibitors, incretin-related drugs, and thiazolidinediones are among the most important oral hypoglycemic drugs used to improve insulin resistance. In this study, the effect of beraprost sodium, a prostaglandin I2 derivative, in the treatment of type 2 diabetes mellitus was investigated. In type 2 diabetic patients with ASO who were under treatment with pioglitazone, additional treatment with beraprost sodium exerted a significant synergistic effect in reducing the serum HbA1c levels as compared to treatment with pioglitazone alone. This result indicates that concomitant administration of pioglitazone and beraprost sodium may be useful in the treatment of diabetes -mellitus.

  16. A clinical study of oral mucous membrane pemphigoid.

    PubMed

    Alkan, A; Günhan, O; Alkan, A; Otan, F

    2003-01-01

    We present 13 cases of oral mucous membrane pemphigoid (MMP) and review the literature. The cases were retrieved from the archives of Ondokuz Mayis University and Gülhane Military Medical Academy, Turkey, between 1997 and 2002. Inclusion criteria were clinical findings of oral MMP verified by histological and immunofluorescent examination. Thirteen patients (two males and 11 females), aged 16-72 years, were identified. Involvement was confined to the mouth in all cases except one, in which the conjunctiva was also affected. Two individuals in the study were < 20 years old, an age group rarely affected. The oral mucosa is often the initial site of MMP lesions, so it is important that dentists as well as physicians are aware of the symptoms and signs. A swift diagnosis, made in consultation with other specialists such as ophthalmologists and dermatologists, is needed in order to prevent a delay in treatment.

  17. Clinic-based intervention to promote literacy. A pilot study.

    PubMed

    Needlman, R; Fried, L E; Morley, D S; Taylor, S; Zuckerman, B

    1991-08-01

    Educational research has shown that children become literate more easily if their parents read to them. A clinic-based program was designed to encourage early book use among parents of children at risk. It included (1) waiting room readers, (2) guidance about literacy development, and (3) provision of children's books at each visit. Seventy-nine parents of children aged 6 to 60 months were interviewed. Parents who had previously received a book were more likely to report looking at books with their children or that looking at books was a favorite activity (adjusted odds ratio, 4.05). This association was strongest among parents receiving Aid to Families With Dependent Children (odds ratio, 7.8). This preliminary study suggests that pediatricians can play a role in enriching children's early literacy environments, especially for children at high risk of school failure.

  18. Prioritization strategies in clinical practice guidelines development: a pilot study

    PubMed Central

    2010-01-01

    Objective Few methodological studies address the prioritization of clinical topics for the development of Clinical Practice Guidelines (CPGs). The aim of this study was to validate a methodology for Priority Determination of Topics (PDT) of CPGs. Methods and results Firstly, we developed an instrument for PDT with 41 criteria that were grouped under 10 domains, based on a comprehensive systematic search. Secondly, we performed a survey of stakeholders involved in CPGs development, and end users of guidelines, using the instrument. Thirdly, a pilot testing of the PDT procedure was performed in order to choose 10 guideline topics among 34 proposed projects; using a multi-criteria analysis approach, we validated a mechanism that followed five stages: determination of the composition of groups, item/domain scoring, weights determination, quality of the information used to support judgments, and finally, topic selection. Participants first scored the importance of each domain, after which four different weighting procedures were calculated (including the survey results). The process of weighting was determined by correlating the data between them. We also reported the quality of evidence used for PDT. Finally, we provided a qualitative analysis of the process. The main domains used to support judgement, having higher quality scores and weightings, were feasibility, disease burden, implementation and information needs. Other important domains such as user preferences, adverse events, potential for health promotion, social effects, and economic impact had lower relevance for clinicians. Criteria for prioritization were mainly judged through professional experience, while good quality information was only used in 15% of cases. Conclusion The main advantages of the proposed methodology are supported by the use of a systematic approach to identify, score and weight guideline topics selection, limiting or exposing the influence of personal biases. However, the methodology was

  19. Clinical Study on 136 Children with Sudden Sensorineural Hearing Loss

    PubMed Central

    Li, Feng-Jiao; Wang, Da-Yong; Wang, Hong-Yang; Wang, Li; Yang, Feng-Bo; Lan, Lan; Guan, Jing; Yin, Zi-Fang; Rosenhall, Ulf; Yu, Lan; Hellstrom, Sten; Xue, Xi-Jun; Duan, Mao-Li; Wang, Qiu-Ju

    2016-01-01

    Background: The prevalence of sudden sensorineural hearing loss in children (CSSNHL) is consistently increasing. However, the pathology and prognosis of CSSNHL are still poorly understood. This retrospective study evaluated clinical characteristics and possible associated factors of CSSNHL. Methods: One hundred and thirty-six CSSNHL patients treated in Department of Otolaryngology-Head and Neck Surgery and Institute of Otolaryngology at Chinese PLA General Hospital between July 2008 and August 2015 were included in this study. These patients were analyzed for clinical characteristics, audiological characteristics, laboratory examinations, and prognostic factors. Results: Among the 136 patients (151 ears), 121 patients (121 ears, 80.1%) were diagnosed with unilaterally CSSNHL, and 15 patients (30 ears, 19.9%) with bilateral CSSNHL. The complete recovery rate of CSSNHL was 9.3%, and the overall recovery rate was 37.7%. We found that initial degree of hearing loss, onset of treatment, tinnitus, the ascending type audiogram, gender, side of hearing loss, the recorded auditory brainstem response (ABR), and distortion product otoacoustic emissions (DPOAEs) had prognostic significance. Age, ear fullness, and vertigo had no significant correlation with recovery. Furthermore, the relevant blood tests showed 30.8% of the children had abnormal white blood cell (WBC) counts, 22.1% had elevated homocysteine levels, 65.8% had high alkaline phosphatase (ALP), 33.8% had high IgE antibody levels, and 86.1% had positive cytomegalovirus (CMV) IgG antibodies. Conclusions: CSSNHL commonly occurs unilaterally and results in severe hearing loss. Initial severe hearing loss and bilateral hearing loss are negative prognostic factors for hearing recovery, while positive prognostic factors include tinnitus, gender, the ascending type audiogram, early treatment, identifiable ABR waves, and DPOAEs. Age, vertigo, and ear fullness are not correlated with the recovery. Some serologic indicators

  20. Venous stasis orbitopathy: a clinical and echographic study.

    PubMed Central

    Atta, H R; Dick, A D; Hamed, L M; Byrne, S F; Gendron, E K; Hughes, R L; Glaser, J S

    1996-01-01

    AIMS: A variety of acute and chronic orbitopathies may be distinguished by standardised echography. Venous stasis orbitopathy (VSO) often presents with orbital signs when secondary to cavernous sinus and middle cranial fossa disorders. In this study, the aim was to assess whether differentiation between vascular and nonvascular causes of VSO could be made on the basis of clinical and echographic features at the time of presentation. METHODS: This study comprised 37 patients with echographic features of VSO (17 patients with arteriovenous fistulae, confirmed by computed tomography imaging or angiography, and 20 patients with non-vascular diseases). Excluded were patients with orbital mass lesions detected by echography and muscle enlargement due to other causes (for example, orbital myositis). Patients with a suspected mass involving the orbital apex and echographic features of VSO were included. After full neuro-ophthalmic and ocular examination, both orbits were examined to document maximal thickness and reflectivity of four recti muscles and compared with the normal contralateral orbit with standardised A-scan (Kretz-technik 7200MA or Ophthascan) and contact B-scan (Ultrascan or Ophthascan S). RESULTS: Cumulative ocular recti muscle thickness was significantly greater in patients with arteriovenous fistulae compared with the non-fistula group (23.3 (SD 3.7) and 17.8 (2) mm, p = 0.001). Clinically, the presence of a bruit and a uniocular rise in intraocular pressure were significantly greater in the fistula group of patients. CONCLUSIONS: Standardised echography is a safe and non-invasive method of diagnosing VSO in patients presenting with signs of proptosis, ophthalmoplegia, and inflammation of the conjunctiva. Furthermore, using these standard techniques the two major causes of VSO (arteriovenous fistulae and compressive mass lesions) could be differentiated. Images PMID:8814742

  1. Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

    PubMed Central

    2010-01-01

    Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches) than just medications alone (50% experience a 50% reduction) and that the effect size of our study involving three different types of biofeedback for migraine (1.09) was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5). These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine. PMID:20205867

  2. The influence of deposit control additives on nitrogen oxides emissions from spark ignition engines (case study: Tehran).

    PubMed

    Bidhendi, Gholamreza Nabi; Zand, Ali Daryabeigi; Tabrizi, Alireza Mikaeili; Pezeshk, Hamid; Baghvand, Akbar

    2007-04-15

    In the present research, the influence of a deposit control additive on NOx emissions from two types of gasoline engine vehicles i.e., Peykan (base on Hillman) and Pride (South Korea Kia motors) was studied. Exhaust NOx emissions were measured in to stages, before decarbonization process and after that. Statistical analysis was conducted on the measurement results. Results showed that NOx emissions from Peykans increased 0.28% and NOx emissions from Pride automobiles decreased 6.18% on average, due to the elimination of engine deposits. The observed variations were not statistically and practically significant. The results indicated that making use of detergent additives is not an effective way to reduce the exhaust NOx emissions from gasoline engine vehicles.

  3. Some clinical and methodological implications of a treatment outcome study of sexually abused children.

    PubMed

    Hyde, C; Bentovim, A; Monck, E

    1995-11-01

    The clinical implications of the results of a treatment outcome study are presented for 47 sexually abused children and adolescents attending a specialist psychiatric facility. The children and their nonabusing parents or caregivers were randomly assigned to contrasting treatment programs. The treatment focused on family members allocating blame for the abuse appropriately, optimizing family relationships, and dealing with causes and effects of the abuse. Clinicians rated the children and the mothers on 12 family treatment aims before and after treatment; on the same occasion additional standardized measures were used to assess behavior and mental state of the children and mental state of the mothers. On the standardized measures mothers made more significant progress than their children in the year of treatment, but there were no effects of type of treatment on the progress made by mothers or children. By contrast, clinical ratings suggested that those following the additional group work made better progress than those following the treatment without group work. The implications of these results for the clinical programs are discussed.

  4. Plaque removal efficacy of Colgate 360 toothbrush: A clinical study

    PubMed Central

    Iyer, Nageshwar; Chandna, Shalu; Dhindsa, Abhishek; Damle, Dhanashree; Loomba, Ashish

    2016-01-01

    Aim: The aim of this clinical study was to confirm the plaque removal efficacy of the Colgate 360 Whole Mouth Clean Toothbrush. Study Design: This was a single-center, monadic, case–controlled study with the 7 days duration. Materials and Methods: A total of eighty participants (56 male and 24 female) aged between 18 and 45 years with a minimum of 20 permanent teeth (excluding the third molars) without any prosthetic crowns and an initial plaque score of minimum 1.5 as determined by Modified Quigley-Hein Plaque Index (1970) participated in the study. There were two dropouts during the study duration, one male and one female. The participants were instructed to brush for 1 min, after which plaque index was recorded again. They were then instructed to brush their teeth twice a day for 1 min with the assigned toothbrush (Colgate 360 Whole Mouth Clean Toothbrush) and a commercially available fluoride toothpaste for the next 7 days. On the 7th day, all the participants were recalled for follow-up and plaque examination. The plaque index scores (pre- and post-brushing) were recorded, tabulated, and analyzed statistically. Results: The mean plaque indices reduced after brushing both on day 1 and day 7. There was also a reduction in mean plaque indices from day 1 to day 7. All these reductions were statistically significant (P < 0.001). The reduction in plaque scores was independent of the gender of the participants however female participants showed lower scores as compared to male participants (P < 0.001). Conclusion: The present study demonstrated a significant reduction in plaque scores with the use of Colgate 360 Whole Mouth Clean Soft Toothbrush throughout the study period. Continued use resulted in a further significant reduction in plaque scores irrespective of the gender of participants. PMID:27630494

  5. Clinical review: the implications of experimental and clinical studies of recruitment maneuvers in acute lung injury.

    PubMed

    Piacentini, Enrique; Villagrá, Ana; López-Aguilar, Josefina; Blanch, Lluis

    2004-04-01

    Mechanical ventilation can cause and perpetuate lung injury if alveolar overdistension, cyclic collapse, and reopening of alveolar units occur. The use of low tidal volume and limited airway pressure has improved survival in patients with acute lung injury or acute respiratory distress syndrome. The use of recruitment maneuvers has been proposed as an adjunct to mechanical ventilation to re-expand collapsed lung tissue. Many investigators have studied the benefits of recruitment maneuvers in healthy anesthetized patients and in patients ventilated with low positive end-expiratory pressure. However, it is unclear whether recruitment maneuvers are useful when patients with acute lung injury or acute respiratory distress syndrome are ventilated with high positive end-expiratory pressure, and in the presence of lung fibrosis or a stiff chest wall. Moreover, it is unclear whether the use of high airway pressures during recruitment maneuvers can cause bacterial translocation. This article reviews the intrinsic mechanisms of mechanical stress, the controversy regarding clinical use of recruitment maneuvers, and the interactions between lung infection and application of high intrathoracic pressures.

  6. A metadata-based patient register for cooperative clinical research: a case study in acute myeloid leukemia.

    PubMed

    Fischer, Anja S; Mansmann, Ulrich

    2011-01-01

    In many medical indications clinical research is organized within study groups which provide and maintain the clinical infrastructure for their randomized clinical trials. Each group also manages a data center where high quality databases store the study specific individual patient data. Sharing this data between study groups is not straightforward. Therefore, a concept is needed which allows to represent a detailed overview on the information available across the cooperating groups. We propose a metadata based patient register and describe a first prototype. It provides information about available patient data sets to interested research partners while the typical register approach only collects a predefined limited core data set. This register implementation enables cooperative groups to allocate clinical data for future research projects in distributed data sources beyond the restrictions of core data sets. Additionally, it supports the research network in communication and data standardization and complies with a governance structure which is compatible with ethical aspects, privacy protection, and patient rights.

  7. Theoretical study of the formation of naphthalene from the radical/π-bond addition between single-ring aromatic hydrocarbons.

    PubMed

    Comandini, Andrea; Brezinsky, Kenneth

    2011-06-09

    The experimental investigations performed in the 1960s on the o-benzyne + benzene reaction as well as the more recent studies on reactions involving π-electrons highlight the importance of π-bonding for different combustion processes related to PAH's and soot formation. In the present investigation radical/π-bond addition reactions between single-ring aromatic compounds have been proposed and computationally investigated as possible pathways for the formation of two-ring fused compounds, such as naphthalene, which serve as precursors to soot formation. The computationally generated optimized structures for the stationary points were obtained with uB3LYP/6-311+G(d,p) calculations, while the energies of the optimized complexes were refined using the uCCSD(T) method and the cc-pVDZ basis set. The computations have addressed the relevance of a number of radical/π-bond addition reactions including the singlet benzene + o-benzyne reaction, which leads to formation of naphthalene and acetylene through fragmentation of the benzobicyclo[2,2,2]octatriene intermediate. For this reaction, the high-pressure limit rate constants for the individual elementary reactions involved in the overall process were evaluated using transition state theory analysis. Other radical/π-bond addition reactions studied were between benzene and triplet o-benzyne, between benzene and phenyl radical, and between phenyl radicals, for all of which potential energy surfaces were produced. On the basis of the results of these reaction studies, it was found necessary to propose and subsequently confirm additional, alternative pathways for the formation of the types of PAH compounds found in combustion systems. The potential energy surface for one reaction in particular, the phenyl + phenyl addition, is shown to contain a low-energy channel leading to formation of naphthalene that is energetically comparable to the other examined conventional pathways leading to formation of biphenyl compounds. This

  8. A functional neuroimaging study of the clinical reasoning of medical students.

    PubMed

    Chang, Hyung-Joo; Kang, June; Ham, Byung-Joo; Lee, Young-Mee

    2016-12-01

    As clinical reasoning is a fundamental competence of physicians for good clinical practices, medical academics have endeavored to teach reasoning skills to undergraduate students. However, our current understanding of student-level clinical reasoning is limited, mainly because of the lack of evaluation tools for this internal cognitive process. This functional magnetic resonance imaging (fMRI) study aimed to examine the clinical reasoning processes of medical students in response to problem-solving questions. We recruited 24 2nd-year medical students who had completed their preclinical curriculum. They answered 40 clinical vignette-based multiple-choice questions during fMRI scanning. We compared the imaging data for 20 problem-solving questions (reasoning task) and 20 recall questions (recall task). Compared to the recall task, the reasoning task resulted in significantly greater activation in nine brain regions, including the dorsolateral prefrontal cortex and inferior parietal cortex, which are known to be associated with executive function and deductive reasoning. During the recall task, significant activation was observed in the brain regions that are related to memory and emotions, including the amygdala and ventromedial prefrontal cortex. Our results support that medical students mainly solve clinical questions with deductive reasoning involving prior knowledge structures and executive functions. The problem-solving questions induced the students to utilize higher cognitive functions compared with the recall questions. Interestingly, the results suggested that the students experienced some emotional distress while they were solving the recall questions. In addition, these results suggest that fMRI is a promising research tool for investigating students' cognitive processes.

  9. Three cases of CLIPPERS: a serial clinical, laboratory and MRI follow-up study.

    PubMed

    Kastrup, O; van de Nes, J; Gasser, T; Keyvani, K

    2011-12-01

    The aim of the study was to further determine the pathophysiology, clinical course, MRI-features and response to therapy of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS), which has recently been proposed as a rare chronic inflammatory central nervous system disorder responsive to immunosuppressive therapy. Three patients with this rare entity underwent serial clinical and bimonthly MRI follow-up over a period of up to 16 months. Extensive laboratory work-up and brain biopsy were performed. Intravenous methylprednisolone or oral dexamethasone was administered as treatment, additionally cyclophosphamide in one patient. Clinically, diplopia, nystagmus, ataxia and facial paresthesia were the cardinal symptoms. Magnetic resonance imaging (MRI) disclosed patchy spot-like gadolinium enhancement in a "salt-and-pepper like appearance" in the pons, midbrain and cerebellum, in two cases with thalamic and in the other with spinal involvement. Brain biopsies demonstrated a predominantly angiocentric but also diffuse infiltration pattern by small mature lymphocytes. Treatment with steroids led to rapid clinical improvement and marked resolution of MRI lesions. As discontinuation of steroids led to clinical relapse, one patient was treated with a further course of steroids and the other with steroids and cyclophosphamide as immunosuppressive therapy. This led to stable remission with only mild clinical residue and normalization of MRI. Extensive laboratory and radiological work-up could not identify any other cause of the disease. Of note, in two cases a marked elevation of IgE in serum was found initially and throughout the course. CLIPPERS seems to be a distinct inflammatory central nervous system disorder. It shows characteristic MRI core features. Extrapontine involvement seems to be frequent. Histologically it is characterised by predominantly angiocentric infiltration by small mature lymphocytes. A pathogenetic

  10. Thrombocytopenia-absent radius syndrome: a clinical genetic study

    PubMed Central

    Greenhalgh, K; Howell, R; Bottani, A; Ancliff, P; Brunner, H; Verschuuren-Bemel..., C; Vernon, E; Brown, K; Newbury-Ecob, R

    2002-01-01

    The thrombocytopenia-absent radius (TAR) syndrome is a congenital malformation syndrome characterised by bilateral absence of the radii and a thrombocytopenia. The lower limbs, gastrointestinal, cardiovascular, and other systems may also be involved. Shaw and Oliver in 1959 were the first to describe this condition, but it was Hall et al in 1969 who reported the first major series of patients. Since then most reports have been based on single or small numbers of cases. We report the results of a clinical study looking at the phenotype of 34 patients with TAR syndrome. All cases had a documented thrombocytopenia and bilateral radial aplasia, 47% had lower limb anomalies, 47% cow's milk intolerance, 23% renal anomalies, and 15% cardiac anomalies. Congenital anomalies not previously described in association with TAR syndrome included facial capillary haemangiomata, intracranial vascular malformation, sensorineural hearing loss, and scoliosis. Karyotype analysis, chromosome breakage studies including premature centromeric separation and fluorescence in situ hybridisation studies looking for a deletion of chromosome 22q11 were undertaken. Two abnormal karyotypes were identified. PMID:12471199

  11. Autogenic training: a meta-analysis of clinical outcome studies.

    PubMed

    Stetter, Friedhelm; Kupper, Sirko

    2002-03-01

    Autogenic training (AT) is a self-relaxation procedure by which a psychophysiological determined relaxation response is elicited. A meta-analysis was performed to evaluate the clinical effectiveness of AT. Seventy-three controlled outcome studies were found (published 1952-99). Sixty studies (35 randomized controlled trials [RCT]) qualified for inclusion in the meta-analysis. Medium-to-large effect sizes (ES) occurred for pre-post comparisons of disease-specific AT-effects, with the RCTs showing larger ES. When AT was compared to real control conditions, medium ES were found. Comparisons of AT versus other psychological treatment mostly resulted in no effects or small negative ES. This pattern of results was stable at follow-up. Unspecific AT-effects (i.e., effects on mood, cognitive performance, quality of life, and physiological variables) tended to be even larger than main effects. Separate meta-analyses for different disorders revealed a significant reduction of the heterogeneity of ES. Positive effects (medium range) of AT and of AT versus control in the meta-analysis of at least 3 studies were found for tension headache/migraine, mild-to-moderate essential hypertension, coronary heart disease, asthma bronchiale, somatoform pain disorder (unspecified type), Raynaud's disease, anxiety disorders, mild-to-moderate depression/dysthymia, and functional sleep disorders.

  12. Virtual patients for assessment of clinical reasoning in nursing -- a pilot study.

    PubMed

    Forsberg, Elenita; Georg, Carina; Ziegert, Kristina; Fors, Uno

    2011-11-01

    In different nursing programmes, one important learning outcome is clinical reasoning (CR) skills. However, to date, there is limited number of methods available for assessment of CR skills; especially for distance-based courses. This study investigates students' opinions about the feasibility of using Virtual Patients (VPs) for assessing CR in nursing education. VPs were introduced as an assessment tool in three different nursing courses at two universities, comprising 77 students in total. Students' overall acceptance of this assessment tool, including its applicability to the practise of nursing and the potential of VP-based assessment as a learning experience, were investigated using questionnaires. Course directors used the Web-SP system to assess students' interactions with VPs and their answers regarding diagnoses, caring procedures and their justifications. Students' found the VP cases to be realistic and engaging, and indicate a high level of acceptance for this assessment method. In addition, the students' indicated that VPs were good for practising their clinical skills, although some would prefer that the VP system be less "medical" and asked for more focus on nursing. Although most students supplied correct diagnoses and made adequate clinical decisions, there was a wide range in their ability to explain their clinical reasoning processes.

  13. Mentoring in Clinical-Translational Research: A Study of Participants in Master's Degree Programs.

    PubMed

    McGinn, Aileen P; Lee, Linda S; Baez, Adriana; Zwanziger, Jack; Anderson, Karl E; Seely, Ellen W; Schoenbaum, Ellie

    2015-12-01

    Research projects in translational science are increasingly complex and require interdisciplinary collaborations. In the context of training translational researchers, this suggests that multiple mentors may be needed in different content areas. This study explored mentoring structure as it relates to perceived mentoring effectiveness and other characteristics of master's-level trainees in clinical-translational research training programs. A cross-sectional online survey of recent graduates of clinical research master's program was conducted. Of 73 surveys distributed, 56.2% (n = 41) complete responses were analyzed. Trainees were overwhelmingly positive about participation in their master's programs and the impact it had on their professional development. Overall the majority (≥75%) of trainees perceived they had effective mentoring in terms of developing skills needed for conducting clinical-translational research. Fewer trainees perceived effective mentoring in career development and work-life balance. In all 15 areas of mentoring effectiveness assessed, higher rates of perceived mentor effectiveness was seen among trainees with ≥2 mentors compared to those with solo mentoring (SM). In addition, trainees with ≥2 mentors perceived having effective mentoring in more mentoring aspects (median: 14.0; IQR: 12.0-15.0) than trainees with SM (median: 10.5; IQR: 8.0-14.5). Results from this survey suggest having ≥2 mentors may be beneficial in fulfilling trainee expectations for mentoring in clinical-translational training.

  14. Oral manifestations of coeliac disease.: A clinical-statistic study.

    PubMed

    Costacurta, M; Maturo, P; Bartolino, M; Docimo, R

    2010-01-01

    AIM.: The aim of the clinical-statistic study was to evaluate the prevalence of the different oral manifestations in a sample of coeliac patients, in comparison with a control group of healthy subjects. Moreover, a second objective was to determine if the clinical oral examination is useful as a diagnostic tool of screening for atypical forms of coeliac disease (CD). METHODS.: The enrolment of 300 coeliac patients, aged between 4 and 13 years (mean age 8.16), was carried out at the Pediatric Dentistry Unit in patients sent from the Pediatric Gastroenterology Unit of the PTV Hospital, University of Rome Tor Vergata. The control group was composed of 300 healthy subjects, age-matched (mean age 8.29), enrolled from the Pediatric Dentistry Unit. The patients were examined for hard tissues (enamel hypoplasia, dental caries), soft tissues (recurrent aphthous stomatitis RAS, atrophic glossitis, geographic tongue) and delay dental eruption. Enamel defects were classified according to Aine's criteria, while dental caries was recorded as dmft/DMFT indices. Statistical analysis was carried out by using SPSS/PC+ Software. Differences between case and control groups were tested using Paired samples T-test, and Chi-Square Test, depending on the variable considered. The minimal level of significance of the differences was fixed at p≤0.05 for all the procedures. RESULTS.: Statistical differences between groups were observed for the prevalence of enamel defects (p=0.0001), RAS (p=0.005), delay in dental eruption (p=0.0001), but not for the prevalence of atrophic glossitis (p=0.664). Differences in symmetrical distribution and a chronologic coherence of enamel defects were statistically significant between CD and control groups (p=0.0001). Regarding dental caries, the coeliac patients had higher indexes of caries than healthy subjects, both in deciduous teeth (dmft 2.31±1.84 vs 1.42±1.13; p= 0.021) and permanent teeth (DMFT 2.97±1.74 vs 1.74±1.64; p=0.0001). CONCLUSIONS.: The

  15. The Relationship between Nerve Conduction Study and Clinical Grading of Carpal Tunnel Syndrome

    PubMed Central

    Cheluvaiah, Janardhan D.; Agadi, Jagadish B.; Nagaraj, Karthik

    2016-01-01

    mild CTS, 25 (50%) had moderate CTS and 9 (18%) had severe CTS clinically. Prolongation of motor latency, latency difference between median and ulnar amplitudes, motor and sensory nerve conduction velocities, sensory latency between median and ulnar nerves, sensory nerve conduction velocities showed significant changes in comparison with controls. Among them sensory latency difference between median and ulnar nerves and sensory nerve conduction velocities are the most sensitive and specific for diagnosing CTS. Conclusion In this study, there was a graded deterioration of electrophysiological parameters along with the clinical severity grades, thus reiterating the fact that NCS provide additional, independent objective evidence in the diagnosis and severity assessment of CTS. The sensory conductions were more sensitive than motor conductions in assessing CTS. PMID:27630881

  16. A study on fibre addition to gluten free bread: its effects on bread quality and in vitro digestibility.

    PubMed

    Sciarini, L S; Bustos, M C; Vignola, M B; Paesani, C; Salinas, C N; Pérez, G T

    2017-01-01

    The aim of this study was to assess the impact of fibre addition on gluten-free (GF) dough properties and bread technological quality, and on protein and starch in vitro digestibility. Soluble (Inulin, In) and insoluble fibres (oat fibre, OF, and type IV resistant starch, RSIV) were used at 5 and 10% substitution levels. Dough firmness increased when insoluble fibres were added, and decreased when In was used. Incorporation of insoluble fibres resulted into bread with a low specific volume (SBV) since firmer dough were more difficult to expand during proofing and baking. Staling rate was reduced after fibre addition, with the exception being OF 10%, as its lower SBV may have favoured molecule re-association. In general, protein and starch digestibility increased when fibres were added at 5%, and then decreased after further increasing the level. Fibres may have disrupted bread crumb structure, thus increasing digestibility, although the higher addition may have led to a physical and/or chemical impediment to digestion. Inulin has well-known physiological effects, while RS presented the most important effect on in vitro starch digestibility (GI). These results showed the possibility of adding different fibres to GF bread to decrease the GI and increase protein digestibility, while obtaining an overall high quality end-product.

  17. A study on the effect of the polymeric additive HPMC on morphology and polymorphism of ortho-aminobenzoic acid crystals

    NASA Astrophysics Data System (ADS)

    Simone, E.; Cenzato, M. V.; Nagy, Z. K.

    2016-07-01

    In the present study, the effect of Hydroxy Propyl Methyl Cellulose (HPMC) on the crystallization of ortho-aminobenzoic acid (OABA) was investigated by seeded and unseeded cooling crystallization experiments. The influence of HPMC on the induction time, crystal shape of Forms I and II of OABA and the polymorphic transformation time was studied. Furthermore, the capability of HPMC to inhibit growth of Form I was evaluated quantitatively and modeled using population balance equations (PBE) solved with the method of moments. The additive was found to strongly inhibit nucleation and growth of Form I as well as to increase the time for the polymorphic transformation from Form II to I. Solvent was also found to influence the shape of Form I crystals at equal concentrations of HPMC. In situ process analytical technology (PAT) tools, including Raman spectroscopy, focused beam reflectance measurement (FBRM) and attenuated total reflectance (ATR) UV-vis spectroscopy were used in combination with off-line techniques, such as optical microscopy, scanning electron microscopy (SEM), Raman spectroscopy, Malvern Mastersizer and differential scanning calorimetry (DSC) to study the crystals produced. The results illustrate how shape, size and stability of the two polymorphs of OABA can be controlled and tailored using a polymeric additive.

  18. Additional studies on side effects of melperone in long-term therapy for 1 to 15 years in psychiatric patients.

    PubMed

    Kirkegaard, A; Kirkegaard, G; Geismar, L; Christensen, I

    1981-01-01

    The present study which reports on the hitherto longest continuous melperone treatment recorded in the literature, was conducted in order to reveal side effects of long-term melperone therapy. 17 female and 20 male patients, aged 33-97 years, most of them with the diagnoses: schizophrenia (11 patients), dementia organica (11 patients) and dementia senilis (11 patients) were treated with melperone (Buronil) in doses of 15--800 mg/day for 1 to 15 years. The patients were examined for clinical side effects, abnormal electrocardiograms and ophthalmological diseases as well as abnormal values in sedimentation rate, hemoglobin, leucocytes, creatinine, alanine-aminotransferase, gamma-glutamyl-transferase and bilirubin. Also the thymol reaction was done. The electrocardiograms and laboratory investigations were controlled by specialists in internal medicine and the eye diseases by an ophthalmologist. We did not find any severe side effects which could be related with any certainty to melperone therapy.

  19. First clinical pilot study with intravascular polarization sensitive optical coherence tomography (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Villiger, Martin; Karanasos, Antonios; Ren, Jian; Lippok, Norman; Shishkov, Milen; Daemen, Joost; Van Mieghem, Nicolas; Diletti, Roberto; Valgimigli, Marco; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; van Soest, Gijs; Nadkarni, Seemantini; Regar, Evelyn; Bouma, Brett E.

    2016-02-01

    Polarization sensitive (PS) OCT measures the polarization states of the light backscattered by tissue and provides measures of tissue birefringence and depolarization in addition to the structural OCT signal. Ex vivo studies have demonstrated that birefringence is increased in tissue rich in collagen and with elevated smooth muscle cell content. Preliminary data further suggests that depolarization can identify regions of macrophage infiltration, lipid, and irregularly arranged collagen fibers. These are important aspects of the mechanical integrity and vulnerability of atherosclerotic plaques. To evaluate the potential of PS-OCT in the clinical setting, we combined our custom PS-OCT system with commercially available OCT catheters (Fastview, Terumo Corporation) and performed a pilot study in 30 patients, scheduled to undergo percutaneous coronary intervention (PCI) on the grounds of stable or unstable angina. A total of 82 pullbacks in 39 vessels were performed, either in the native coronary arteries or post procedure. Comparing consecutive pullbacks of the same coronary artery, we found excellent agreement between the polarization features in the repeat pullbacks, validating the repeatability and robustness of PS-OCT in the clinical in vivo setting. In addition we observed that the birefringence and depolarization features vary significantly across lesions with identical structural OCT appearance, suggesting morphological subtypes. This first human pilot study proved the feasibility and robustness of intravascular PS-OCT. PS-OCT achieves improved tissue characterization and may help in identifying high-risk plaques, with the potential to ultimately improve risk stratification and help guiding PCI.

  20. A SEARCH FOR ADDITIONAL PLANETS IN FIVE OF THE EXOPLANETARY SYSTEMS STUDIED BY THE NASA EPOXI MISSION

    SciTech Connect

    Ballard, Sarah; Charbonneau, David; Holman, Matthew J.; Christiansen, Jessie L.; Deming, Drake; Barry, Richard K.; Kuchner, Marc J.; Livengood, Timothy A.; Hewagama, Tilak; Hampton, Don L.; Lisse, Carey M.; Seager, Sara; Veverka, Joseph F.

    2011-05-01

    We present time series photometry and constraints on additional planets in five of the exoplanetary systems studied by the EPOCh (Extrasolar Planet Observation and Characterization) component of the NASA EPOXI mission: HAT-P-4, TrES-3, TrES-2, WASP-3, and HAT-P-7. We conduct a search of the high-precision time series for photometric transits of additional planets. We find no candidate transits with significance higher than our detection limit. From Monte Carlo tests of the time series using putative periods from 0.5 days to 7 days, we demonstrate the sensitivity to detect Neptune-sized companions around TrES-2, sub-Saturn-sized companions in the HAT-P-4, TrES-3, and WASP-3 systems, and Saturn-sized companions around HAT-P-7. We investigate in particular our sensitivity to additional transits in the dynamically favorable 3:2 and 2:1 exterior resonances with the known exoplanets: if we assume coplanar orbits with the known planets, then companions in these resonances with HAT-P-4b, WASP-3b, and HAT-P-7b would be expected to transit, and we can set lower limits on the radii of companions in these systems. In the nearly grazing exoplanetary systems TrES-3 and TrES-2, additional coplanar planets in these resonances are not expected to transit. However, we place lower limits on the radii of companions that would transit if the orbits were misaligned by 2.{sup 0}0 and 1.{sup 0}4 for TrES-3 and TrES-2, respectively.

  1. Gentamicin-mediated ototoxicity and nephrotoxicity: A clinical trial study

    PubMed Central

    Saleh, Parviz; Abbasalizadeh, Shamsi; Rezaeian, Saman; Naghavi-Behzad, Mohammad; Piri, Reza; Pourfeizi, Hojjat Hossein

    2016-01-01

    Background: Aminoglycosides and mainly gentamicin are the most important antimicrobial agents. Two different methods of administration exist: Single and multiple doses. There has always been a controversy about the less harmful administration method, to minimize adverse effects of gentamicin – deafness and renal insufficiency. In this study, it was aimed to compare two different methods of administration to figure out the least harmful treatment method. Materials and Methods: In a clinical study, eighty patients aged 12–55 years who were admitted with sepsis syndrome were included in the study; they were divided into two groups: The first group received single-dose treatment (5 mg/kg) whereas the second group was treated with multiple doses (1.7 mg/kg three times a day) of gentamicin. Results: The results show that blood urea nitrogen (BUN) and creatinine (CR) levels were decreased in the first group. Both blood urea nitrogen and creatinine and also mean glomerular filtration rate was increased in the same group. In the second group, mean BUN and CR levels were increased while the GFR was decreased in the same group. There was also a gradual increase in GFR in the first group. GFR <80 was decreased from 20% to 5.1% in the first group while increased from 5% to 27.5% in the second group. Results of audiometric studies show 6.1% hearing problem in the first group and 12.8% in the second one. Conclusions: Results of the present study showed that nephrotoxicity and ototoxicity are minimized in single-dose administration compared to multiples doses. PMID:27942103

  2. StudySearch: a web-based application for posting and searching clinical research studies

    PubMed Central

    Gonsenhauser, Blair; Hallarn, Rose; Carpenter, Daniel; Para, Michael F; Reider, Carson R

    2016-01-01

    Participant accrual into research studies is critical to advancing clinical and translational research to clinical care. Without sufficient recruitment, the purpose of any research study cannot be realized; yet, low recruitment and enrollment of participants persist. StudySearch is a web-based application designed to provide an easily readable, publicly accessible, and searchable listing of IRB-approved protocols that are accruing study participants. The Regulatory, Recruitment and Biomedical Informatics Cores of the Center for Clinical and Translational Science (CCTS) at The Ohio State University developed this research study posting platform. Postings include basic descriptive information: study title, purpose of the study, eligibility criteria and study personnel contact information. Language concerning benefits and/or inducements is not included; therefore, while IRB approval for a study to be listed on StudySearch is required, IRB approval of the posted language is not. Studies are listed by one of two methods; one automated and one manual: (1). Studies registered on ClinicalTrials.gov are automatically downloaded once a month; or (2). Studies are submitted directly by researchers to the CCTS Regulatory Core staff. In either case, final language is a result of an iterative process between researchers and CCTS staff. Deployed in January 2011 at OSU, this application has grown to approximately 200 studies currently posted and 1500 unique visitors per month. Locally, StudySearch is part of the CCTS recruitment toolkit. Features continue to be modified to better accommodate user behaviors. Nationally, this open source application is available for use. PMID:26912012

  3. Untangling Uncertainty: A Study of the Discourses Shaping Clinical Ethics Consultation as a Professional Practice.

    PubMed

    Saxén, Salla

    2016-01-01

    This qualitative social scientific interview study delves into the ways in which professional vision is constructed in clinical ethics consultation (CEC). The data consist of 11 semi-structured interviews that were conducted with clinical ethics consultants currently working in hospitals in one major urban area in the U.S. The interviews were analyzed with the qualitative research method of critical discourse analysis, with a focus on identifying the cultural structures of knowledge that shape CEC as a professional practice. The discourses were first identified as belonging to two higher discourse categories, order and agency. Order was divided into three lower categories, emotional, managerial, and rational order, and discourses of agency into the lower categories of exploration, technique, deliberation, and distancing. An additional discourse of neutral interaction was identified as a bridging discourse, activated to level tensions emerging out of conflicting goals and agencies embedded in CEC practice. This analysis brings out as its main observation that clinical ethics consultants draw on and shift between potentially ideologically conflicting social positions that can create built-in tensions within the professional domain. The study calls attention to these tensions and suggests for the professional group to discuss the possibility of defining priorities between different kinds of order, identified in this study, that shape the CEC domain.

  4. Reference values of clinical pathology parameters in cynomolgus monkeys (Macaca fascicularis) used in preclinical studies

    PubMed Central

    Park, Hyun-Kyu; Cho, Jae-Woo; Lee, Byoung-Seok; Park, Heejin; Han, Ji-Seok; Yang, Mi-Jin; Im, Wan-Jung; Park, Do-Yong; Kim, Woo-Jin; Han, Su-Cheol

    2016-01-01

    Nonhuman primates are increasingly used in biomedical research since they are highly homologous to humans compared to other rodent animals. However, there is limited reliable reference data of the clinical pathology parameters in cynomolgus monkeys, and in particular, only some coagulation and urinalysis parameters have been reported. Here, we reported the reference data of clinical chemical, hematological, blood coagulation, and urinalysis parameters in cynomolgus monkeys. The role of sex differences was analyzed and several parameters (including hematocrit, hemoglobin, red blood cell, blood urea nitrogen, total bilirubin, alkaline phosphatase, creatinine kinase, gamma-glutamyl tranferase, and lactate dehydrogenase) significantly differed between male and female subjects. In addition, compared to previous study results, lactate dehydrogenase, creatinine kinase, and aspartate aminotransferase showed significant variation. Interstudy differences could be affected by several factors, including age, sex, geographic origin, presence/absence of anesthetics, fasting state, and the analytical methods used. Therefore, it is important to deliberate with the overall reference indices. In conclusion, the current study provides a comprehensive and updated reference data of the clinical pathology parameters in cynomolgus monkeys and provides improved assessment criteria for evaluating preclinical studies or biomedical research. PMID:27382375

  5. Tretinoin-loaded liposomal formulations: from lab to comparative clinical study in acne patients.

    PubMed

    Rahman, Salwa Abdel; Abdelmalak, Nevine Shawky; Badawi, Alia; Elbayoumy, Tahany; Sabry, Nermeen; El Ramly, Amany

    2016-05-01

    Topical tretinoin is the most commonly used retinoid for acne. However, its irritative potential on the applied area and the barrier properties of the stratum corneum limit its use. The objective of the present study was to formulate tretinoin liposomal gel to obtain a formula with lower skin irritation potential and greater clinical effect. A statistical 2(4) factorial design was adopted. Sixteen formulae prepared and were properly evaluated. A candidate formula (F13G) prepared with 0.025% tretinoin, phospholipid- cholesterol-dicetylphosphate (9:1:0.01) and incorporated in 1% carbopol gel was selected for skin irritation test. Clinical study was conducted on acne patients and compared to marketed product. All liposomes formulations were spherical in shape. The addition of cholesterol in the film hydration method significantly decreased the vesicle size, and increased the percentage of incorporation efficiency at (p < 0.05). The presence of dicetylphosphate significantly increased drug release but did not affect the percentage of incorporation efficiency and vesicle size. The results of the clinical study in acne patients revealed that F13G showed significantly higher efficacy when compared to marketed product (p < 0.05).

  6. Autologous myoblast transplantation for oculopharyngeal muscular dystrophy: a phase I/IIa clinical study.

    PubMed

    Périé, Sophie; Trollet, Capucine; Mouly, Vincent; Vanneaux, Valérie; Mamchaoui, Kamel; Bouazza, Belaïd; Marolleau, Jean Pierre; Laforêt, Pascal; Chapon, Françoise; Eymard, Bruno; Butler-Browne, Gillian; Larghero, Jérome; St Guily, Jean Lacau

    2014-01-01

    Oculopharyngeal muscular dystrophy (OPMD) is a late-onset autosomal dominant genetic disease mainly characterized by ptosis and dysphagia. We conducted a phase I/IIa clinical study (ClinicalTrials.gov NCT00773227) using autologous myoblast transplantation following myotomy in adult OPMD patients. This study included 12 patients with clinical diagnosis of OPMD, indication for cricopharyngeal myotomy, and confirmed genetic diagnosis. The feasibility and safety end points of both autologous myoblast transplantation and the surgical procedure were assessed by videoendoscopy in addition to physical examinations. Potential therapeutic benefit was also assessed through videoendoscopy and videofluoroscopy of swallowing, quality of life score, dysphagia grade, and a drink test. Patients were injected with a median of 178 million myoblasts following myotomy. Short and long-term (2 years) safety and tolerability were observed in all the patients, with no adverse effects. There was an improvement in the quality of life score for all 12 patients, and no functional degradation in swallowing was observed for 10 patients. A cell dose-dependant improvement in swallowing was even observed in this study. This trial supports the hypothesis that a local injection of autologous myoblasts in the pharyngeal muscles is a safe and efficient procedure for OPMD patients.

  7. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    PubMed

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  8. What Leads Indians to Participate in Clinical Trials? A Meta-Analysis of Qualitative Studies

    PubMed Central

    Shah, Jatin Y.; Phadtare, Amruta; Rajgor, Dimple; Vaghasia, Meenakshi; Pradhan, Shreyasee; Zelko, Hilary; Pietrobon, Ricardo

    2010-01-01

    Background With the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials. Methods We conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus. Results Six qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers. Conclusion We identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India. PMID:20505754

  9. 21 CFR 312.120 - Foreign clinical studies not conducted under an IND.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Foreign clinical studies not conducted under an....120 Foreign clinical studies not conducted under an IND. (a) Acceptance of studies. (1) FDA...

  10. 21 CFR 312.120 - Foreign clinical studies not conducted under an IND.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Foreign clinical studies not conducted under an....120 Foreign clinical studies not conducted under an IND. (a) Acceptance of studies. (1) FDA...

  11. 21 CFR 312.120 - Foreign clinical studies not conducted under an IND.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Foreign clinical studies not conducted under an....120 Foreign clinical studies not conducted under an IND. (a) Acceptance of studies. (1) FDA...

  12. 21 CFR 312.120 - Foreign clinical studies not conducted under an IND.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Foreign clinical studies not conducted under an....120 Foreign clinical studies not conducted under an IND. (a) Acceptance of studies. (1) FDA...

  13. Radiation dose enhancement in skin therapy with nanoparticle addition: A Monte Carlo study on kilovoltage photon and megavoltage electron beams

    PubMed Central

    Zheng, Xiao J; Chow, James C L

    2017-01-01

    AIM To investigated the dose enhancement due to the incorporation of nanoparticles in skin therapy using the kilovoltage (kV) photon and megavoltage (MV) electron beams. Monte Carlo simulations were used to predict the dose enhancement when different types and concentrations of nanoparticles were added to skin target layers of varying thickness. METHODS Clinical kV photon beams (105 and 220 kVp) and MV electron beams (4 and 6 MeV), produced by a Gulmay D3225 orthovoltage unit and a Varian 21 EX linear accelerator, were simulated using the EGSnrc Monte Carlo code. Doses at skin target layers with thicknesses ranging from 0.5 to 5 mm for the photon beams and 0.5 to 10 mm for the electron beams were determined. The skin target layer was added with the Au, Pt, I, Ag and Fe2O3 nanoparticles with concentrations ranging from 3 to 40 mg/mL. The dose enhancement ratio (DER), defined as the dose at the target layer with nanoparticle addition divided by the dose at the layer without nanoparticle addition, was calculated for each nanoparticle type, nanoparticle concentration and target layer thickness. RESULTS It was found that among all nanoparticles, Au had the highest DER (5.2-6.3) when irradiated with kV photon beams. Dependence of the DER on the target layer thickness was not significant for the 220 kVp photon beam but it was for 105 kVp beam for Au nanoparticle concentrations higher than 18 mg/mL. For other nanoparticles, the DER was dependent on the atomic number of the nanoparticle and energy spectrum of the photon beams. All nanoparticles showed an increase of DER with nanoparticle concentration during the photon beam irradiations regardless of thickness. For electron beams, the Au nanoparticles were found to have the highest DER (1.01-1.08) when the beam energy was equal to 4 MeV, but this was drastically lower than the DER values found using photon beams. The DER was also found affected by the depth of maximum dose of the electron beam and target thickness. For

  14. Clinical study in phase- contrast mammography: image-quality analysis.

    PubMed

    Longo, Renata; Tonutti, Maura; Rigon, Luigi; Arfelli, Fulvia; Dreossi, Diego; Quai, Elisa; Zanconati, Fabrizio; Castelli, Edoardo; Tromba, Giuliana; Cova, Maria A

    2014-03-06

    The first clinical study of phase-contrast mammography (PCM) with synchrotron radiation was carried out at the Synchrotron Radiation for Medical Physics beamline of the Elettra synchrotron radiation facility in Trieste (Italy) in 2006-2009. The study involved 71 patients with unresolved breast abnormalities after conventional digital mammography and ultrasonography exams carried out at the Radiology Department of Trieste University Hospital. These cases were referred for mammography at the synchrotron radiation facility, with images acquired using a propagation-based phase-contrast imaging technique. To investigate the contribution of phase-contrast effects to the image quality, two experienced radiologists specialized in mammography assessed the visibility of breast abnormalities and of breast glandular structures. The images acquired at the hospital and at the synchrotron radiation facility were compared and graded according to a relative seven-grade visual scoring system. The statistical analysis highlighted that PCM with synchrotron radiation depicts normal structures and abnormal findings with higher image quality with respect to conventional digital mammography.

  15. Thermographic diagnostics to discriminate skin lesions: a clinical study

    NASA Astrophysics Data System (ADS)

    Stringasci, Mirian Denise; Moriyama, Lilian Tan; Salvio, Ana Gabriela; Bagnato, Vanderlei Salvador; Kurachi, Cristina

    2015-06-01

    Cancer is responsible for about 13% of all causes of death in the world. Over 7 million people die annually of this disease. In most cases, the survival rates are greater when diagnosed in early stages. It is known that tumor lesions present a different temperature compared with the normal tissues. Some studies have been performed in an attempt to establish new diagnosis methods, targeting this temperature difference. In this study, we aim to investigate the use of a handheld thermographic camera to discriminate skin lesions. The patients presenting Basal Cell Carcinoma, Squamous Cell Carcinoma, Actinic Keratosis, Pigmented Seborrheic Keratosis, Melanoma or Intradermal Nevus lesions have been investigated at the Skin Departament of Amaral Carvalho Hospital. Patients are selected by a dermatologist, and the lesion images are recorded using an infrared camera. The images are evaluated taken into account the temperature level, and differences into lesion areas, borders, and between altered and normal skin. The present results show that thermography may be an important tool for aiding in the clinical diagnostics of superficial skin lesions.

  16. Digital Mucous Cyst: A Clinical-Surgical Study

    PubMed Central

    Kim, Eun Jung; Huh, Joon Won

    2017-01-01

    Background It has been suggested digital mucous cysts (DMCs) are associated with osteoarthritis and osteophytes in the elderly, and usually have a communicating pedicle with the joint. Surgical excision is a standard therapy with a high cure rate. Objective The purpose of this prospective study is to evaluate the features of DMCs via clinical, radiological and pathological examination and the efficacy of surgical excision of DMCs. Methods Between 2010 and 2014, 24 Korean patients were treated with the resection of the cyst and the pedicle. Preoperative X-ray and ultrasonography were performed to detect the presence of the osteophyte and the connection to the joint space. Postoperative patients' satisfaction score was assessed by the visual analogue scale (0~10). Results The osteophytes were found in 15.8%. In ultrasonographic findings, there were prominent flow signals between the cyst and the joint space in 13.6%. There were no serious postoperative complications, and recurrences were observed in 16.7%. Mean postoperative satisfaction score was 8.3. Conclusion It seems that preoperative X-ray for osteophytes and ultrasonographic study for connection are not always helpful for the treatment of DMCs, and that the surgical excision with a pedicle ligation and electrocoagulation is an effective treatment modality. PMID:28223749

  17. Using clinical element models for pharmacogenomic study data standardization.

    PubMed

    Zhu, Qian; Freimuth, Robert R; Pathak, Jyotishman; Chute, Christopher G

    2013-01-01

    Standardized representations for pharmacogenomics data are seldom used, which leads to data heterogeneity and hinders data reuse and integration. In this study, we attempted to represent data elements from the Pharmacogenomics Research Network (PGRN) that are related to four categories, patient, drug, disease and laboratory, in a standard way using Clinical Element Models (CEMs), which have been adopted in the Strategic Health IT Advanced Research Project, secondary use of EHR (SHARPn) as a library of common logical models that facilitate consistent data representation, interpretation, and exchange within and across heterogeneous sources and applications. This was accomplished by grouping PGRN data elements into categories based on UMLS semantic type, then mapping each to one or more CEM attributes using a web-based tool that was developed to support curation activities. This study demonstrates the successful application of SHARPn CEMs to the pharmacogenomic domain. It also identified several categories of data elements that are not currently supported by SHARPn CEMs, which represent opportunities for further development and collaboration.

  18. Preclinical and Clinical Studies for Sodium Tungstate: Application in Humans.

    PubMed

    Bertinat, Romina; Nualart, Francisco; Li, Xuhang; Yáñez, Alejandro J; Gomis, Ramón

    2015-02-01

    Diabetes is a complex metabolic disorder triggered by the deficient secretion of insulin by the pancreatic β-cell or the resistance of peripheral tissues to the action of the hormone. Chronic hyperglycemia is the major consequence of this failure, and also the main cause of diabetic problems. Indeed, several clinical trials have agreed in that tight glycemic control is the best way to stop progression of the disease. Many anti-diabetic drugs for treatment of type 2 diabetes are commercially available, but no ideal normoglycemic agent has been developed yet. Moreover, weight gain is the most common side effect of many oral anti-diabetic agents and insulin, and increased weight has been shown to worsen glycemic control and increase the risk of diabetes progression. In this sense, the inorganic salt sodium tungstate (NaW) has been studied in different animal models of metabolic syndrome and diabetes, proving to have a potent effect on normalizing blood glucose levels and reducing body weight, without any hypoglycemic action. Although the liver has been studied as the main site of NaW action, positive effects have been also addressed in muscle, pancreas, brain, adipose tissue and intestine, explaining the effective anti-diabetic action of this salt. Here, we review NaW research to date in these different target organs. We believe that NaW deserves more attention, since all available anti-diabetic treatments remain suboptimal and new therapeutics are urgently needed.

  19. Minor intraoral salivary gland tumors: a clinical-pathological study

    PubMed Central

    Sarmento, Dmitry José de Santana; Morais, Maria de Lourdes Silva de Arruda; Costa, Antonio de Lisboa Lopes; da Silveira, Éricka Janine Dantas

    2016-01-01

    ABSTRACT Objective To evaluate the clinical-pathological profile of patients with minor salivary gland neoplasms. Methods A retrospective study of specific cases diagnosed as benign and malignant tumors of the minor salivary glands was performed. The data were collected from medical records of patients seen at a hospital over a period of 15 years. The sample was made up of 37 cases. For the pathological study, slides containing 5μm thick sections stained with hematoxylin and eosin were used. The data were tabulated using descriptive statistics. Results Malignant neoplasms represented 70.3% of cases. The mucoepidermoid carcinoma was the most common neoplasm (45.9%), followed by pleomorphic adenoma (24.4%). Most patients were female (70.3%), aged between 71 and 80 years. The palate (67.6%) and the retromolar region (10.8%) were the most affected sites. Conclusion Mucoepidermoid carcinoma was the most common tumor in minor salivary glands. These tumors are more common in females aged over 40 years. The palate was the most common affected site. PMID:28076598

  20. [Functional aniseikonia: clinical study of 110 cases (author's transl)].

    PubMed

    Reboud, F N; Vola, J L; Berard, P V

    1981-01-01

    A clinical study was conducted in 110 cases of subjective aniseikonia, a syndrome that is often neglected. After in practice summarizing the different distortions composing the phenomenon of aniseikonia, a description of the prototype apparatus used for the experiments is given: it is eikonometric stereo-projector the originality of which lies in the measuring system, constituted by the projected stereograms. Three parameters were studied: depth-perception, peerception threshold of anseiikonic disparity, and value of the found aniseikonia. The results are presented in relation to 3 groups of subjects: 14 emmetropic, 32 isometropic, and 64 anisometropic, 32 isometropic, and 64 anisometropic patients, including 24 monocular aphakic. The author shows the advantage of contact lens correction in the last cases: with an average of 3.5 p. cent, the found aniseikonia was always inferior to 6 p. cent and to the theorectical levels currently accepted. Finally, the phenomenon of "cortical malleability" arises in the adaptation of the patient to his optical correction and could regularly and progressively be increased.

  1. Thrombosis preventive potential of chicory coffee consumption: a clinical study.

    PubMed

    Schumacher, Edit; Vigh, Eva; Molnár, Valéria; Kenyeres, Péter; Fehér, Gergely; Késmárky, Gábor; Tóth, Kálmán; Garai, János

    2011-05-01

    The protective effects of plant polyphenol intake on cardiovascular morbidity and mortality are widely acknowledged. Caffeine-free chicory coffee is a rich source of plant phenolics, including caffeic acid, which inhibits in vitro platelet aggregation, and also phenylpyruvate tautomerase enzymatic activity of the proinflammatory cytokine, macrophage migration inhibitory factor (MIF). To assess whether chicory coffee consumption might confer cardiovascular benefits a clinical intervention study was performed with 27 healthy volunteers, who consumed 300 mL chicory coffee every day for 1 week. The dietary intervention produced variable effects on platelet aggregation, depending on the inducer used for the aggregation test. Whole blood and plasma viscosity were both significantly decreased, along with serum MIF levels, after 1 week of chicory coffee consumption. Moreover, significant improvements were seen in red blood cell deformability. No changes in hematocrit, fibrinogen level or red blood cell counts were detected. The full spectrum of these effects is unlikely to be attributable to a single compound present in chicory coffee, nevertheless, the phenolics, including caffeic acid, are expected to play a substantial role. In conclusion, our study offers an encouraging starting-point to delineate the antithrombotic and antiinflammatory effects of phenolic compounds found in chicory coffee.

  2. Can additional urban development have major impacts on streamflow of a peri-urban catchment? A case study from Portugal

    NASA Astrophysics Data System (ADS)

    Ferreira, Carla; Walsh, Rory; Nunes, João; Steenhuis, Tammo; de Lima, João; Coelho, Celeste; Ferreira, António

    2016-04-01

    It is well known that urban development brings about changes in hydrological response. Relatively little, however, is known about impacts on streamflow during urban development in the Mediterranean climate. This paper examines changes in streamflow resulting from the construction of an enterprise park, a major road and apartment blocks in a small partially urbanized peri-urban catchment (6.2 km2) in central Portugal. These developments led to an increase in urban area from 32% to 40% over a five-year period (hydrological years 2008/09-2012/13). In the initial two-year period minor land-use changes increased impervious surfaces from 12.8% to 13.2%. The subsequent three-year period led to a further 17.2% increase in impervious area. Streamflow was recorded by a V-notch weir at the catchment outlet. Rainfall was recorded at a weather station 0.5km north of the catchment, and by five tipping-bucket raingauges installed in January 2011 within the study catchment. Annual runoff and storm runoff coefficients ranged from 14% to 21% and 9% to 14%, respectively, recorded in 2011/12 and 2012/13. Although these differences in runoff were caused in part by variation in rainfall, the comparison between 2009/10 (pre-) and 2012/13 (post-additional urban development), with broadly similar rainfall (887mm vs 947mm, respectively) and evapotranspiration (740mm vs 746mm), showed a 43% increase in storm runoff (from 90mm to 129mm), resulting from additional overland flow generated largely by the 4.4% increase in impervious surfaces. The additional urban development also led to changes in hydrograph parameters. The increase in storm runoff was not progressive over the study period, but regression lines of storm runoff against rainstorm parameters exhibited higher vertical positions in 2012/13 than 2008/09. Increasing peak flows, however, were more progressive over the study period, with annual regression lines displaying higher vertical positions, but with a clear distance between pre

  3. Phase I study of intravenous iododeoxyuridine as a clinical radiosensitizer

    SciTech Connect

    Kinsella, T.J.; Russo, A.; Mitchell, J.B.; Collins, J.M.; Rowland, J.; Wright, D.; Glatstein, E.

    1985-11-01

    Twenty-four patients with locally advanced (19 patients) or metastatic (5 patients) tumors were treated in a Phase I study combining constant intravenous infusions of iododeoxyuridine (IUdR) and hyperfractionated radiation therapy. IUdR was given as a constant infusion for 12 hours/day for two separate 14-day infusion periods in most patients. The dose of IUdR was escalated from 250 to 1200 mg/m2/12-hour infusion in this study. The initial tumor volume was treated to 45 Gy/1.5 Gy BID/3 weeks followed by a cone-down boost to 20-25 Gy/1.25 Gy BID/2 weeks after a planned 2-week break. THe IUdR infusion preceded the initial and cone-down irradiation by 1 week. Local acute toxicity (within the radiation volume) was uncommon and few patients required an alteration of the planned treatment schedule. Two patients developed late local toxicity with one patient showing clinical signs of radiation hepatitis and another patient developing a large bowel obstruction that required surgical bypass. Dose-limiting systemic toxicity was confined to the bone marrow with moderate to severe thrombocytopenia developing on Day 10-14 of infusions at 1200 mg/m2/12 hours. Mild stomatitis and partial alopecia occurred in some patients at this dose level. No systemic skin toxicity was seen. Pharmacology studies revealed steady-state arterial plasma levels of IUdR of 1 to 8 X 10(-6) M over the dose range used. In vivo IUdR incorporation into tumors was studied in three patients with high-grade sarcomas using an anti-IUdR monoclonal antibody and immunohistochemistry and demonstrated incorporation in up to 50-70% of tumor cells. The preliminary treatment results, particularly in patients with unresectable sarcomas, are encouraging.

  4. Legitimating Clinical Research in the Study of Organizational Culture.

    ERIC Educational Resources Information Center

    Schein, Edgar H.

    1993-01-01

    Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

  5. Reflection-in-Action: Case Study of a Clinical Supervisor.

    ERIC Educational Resources Information Center

    Turner-Muecke, Lee A.

    1986-01-01

    Applies Donald Schon's concept of the "reflective practitioner" to Robert Goldhammer's clinical supervision cycle (pre-observation conference, observation, analysis and strategy, supervision conference, and postconference analysis), stressing personal growth purposes for teacher and supervisor alike. Explores a clinical supervisor's…

  6. Rational-emotive therapy and depression: a clinical case study.

    PubMed

    Horton, A M; Johnson, C H

    1980-12-01

    Rational-emotive group and bibliotherapy were used to treat a depressed patient in a clinical setting. Psychological test data document a dramatic improvement. It is suggested that rational-emotive therapy may prove efficacious for the treatment of some depressed patients in clinical settings.

  7. From linked open data to molecular interaction: studying selectivity trends for ligands of the human serotonin and dopamine transporter† †The authors declare no competing interests. ‡ ‡Electronic supplementary information (ESI) available. See DOI: 10.1039/c6md00207b Click here for additional data file. Click here for additional data file. Click here for additional data file. Click here for additional data file. Click here for additional data file. Click here for additional data file. Click here for additional data file. Click here for additional data file.

    PubMed Central

    Hellsberg, Eva; Viereck, Michael; Ecker, Gerhard F.

    2016-01-01

    Retrieval of congeneric and consistent SAR data sets for protein targets of interest is still a laborious task to do if no appropriate in-house data set is available. However, combining integrated open data sources (such as the Open PHACTS Discovery Platform) with workflow tools now offers the possibility of querying across multiple domains and tailoring the search to the given research question. Starting from two phylogenetically related protein targets of interest (the human serotonin and dopamine transporters), the whole chemical compound space was explored by implementing a scaffold-based clustering of compounds possessing biological measurements for both targets. In