analysis of adverse events in clinical trials

... 15,000 patients in nine of the earlier trials of celecoxib, and Edwards and co-workers [30] examined some 5,700 patients in nine trials of valdecoxib Reviews looking at adverse events generally ... scoring reporting quality and validity in pain trials Use of similar methods for collecting and reporting adverse events ensured data of uniform nature and quality The average age in the trials ... fewer adverse- event discontinuations or gastrointestinal -adverse- event discontinuations There were fewer adverse events overall, treatmentrelated adverse events, combined and individual gastrointestinal...

Ngày tải lên: 09/08/2014, 06:22

Ngày tải lên: 09/08/2014, 07:20

... Measurement of health status Ascertaining the minimal clinically important difference Control Clin Trials 1989, 10:407-415 Juniper EF, Guyatt GH, Willan A, Griffith LE: Determining a minimal important ... instrument for assessing symptom severity and response to treatment in clinical trials of patients with GERD 10 11 12 Competing interests The authors declare that they have no competing interests 13 ... evaluation of instruments includes item selection and multitrait scaling, internal consistency of items that combine into a dimension [17], as well as confirmation of convergent and/or discriminant...

Ngày tải lên: 18/06/2014, 22:20

... association of high IgM ACL with preterm delivery Treatment of women with SLE during pregnancy with aspirin and/or heparin is not, however, standard clinical practice in Trinidad These findings suggest ... times of the day, including weekends and after working hours, in order to interview potential control individuals Blood was taken for DNA and serum storage prior to analyses at the time of interview ... misreporting might suggest that the higher pregnancy loss rate in our study could be explained by a higher proportion of induced abortion in this age group Our findings for foetal death overall (24% in...

Ngày tải lên: 09/08/2014, 10:22

... understanding of information related to clinical trials The appreciation of children and adolescents and their parents of what a clinical trial involved and their reasoning about participation in a clinical ... concept of clinical trials were investigated The answers were analysed using qualitative methods to gain insight into the decision-making process of children and adolescents Analysis was conducted in ... need further information As the aim cannot be to obtain informed consent in a legal meaning from legal minors or young children, the primary target of clinical investigators in clinical studies...

Ngày tải lên: 13/08/2014, 18:21

... variety of antidepressants, including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors [5,6] The trials in this analysis all included ... Montgomery-sberg Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials Int Clin Psychopharmacol 2002, 17:281-285 ... sensitivity of the Montgomery-sberg Depression Rating Scale, the Hamilton Depression Rating Scale and the Clinical Global Impressions Rating Scale in antidepressant clinical trials: a replication analysis...

Ngày tải lên: 08/08/2014, 23:21

... Even in acute pain studies, the method of adverse event ascertainment can influence measured adverse event prevalence [18] Less than adequate reporting of adverse event information in clinical trials ... frequency of placebo control was highest in neuropathic pain studies, with four of five trials and 87% of patients The policy of including trials without a placebo increased the potential amount of information ... quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996, 17:1-12 Doak W, Hosie J, Hossaine M, James IG, Reid I, Miller AJ: A novel combination of ibuprofen...

Ngày tải lên: 09/08/2014, 06:23

... significant treatment effect Inefficient analysis of trials may contribute this the failure • Dichotomous analysis of an ordinal outcome scale in clinical trials results in loss of information Previous ... ordinal outcome analysis that were investigated in the present study resulted in substantial power increase Therefore, we strongly recommend incorporating ordinal methods in the analysis of future ... approaches are often used in the analysis of trials conducted for other indications For example, in stroke the modified Rankin scale, which is also an ordinal scale, consisting of six categories,...

Ngày tải lên: 14/08/2014, 08:21

... versus streptokinase for prevention of myocardial infarction, with a finding in favor of aspirin In subgroup analyses by astrological sign, the authors found that patients born under Gemini or Libra ... “Since the investigator can describe only to a limited extent the kinds of participants in whom an intervention was evaluated, a leap of faith is always required when applying any study findings ... of drug over placebo involve a very small 58 Chapter 8: Clinical trials effect size, when all RCTs are pooled in meta -analysis (Kirsch et al., 2008) One should keep in mind though that meta-analysis...

Ngày tải lên: 01/11/2013, 11:20

... significant findings were found concerning the endogenous axis of DMS and the HDRS depressive index The interaction of PD and DST produced significant findings concerning age, age of onset, number of atypical ... papers in the international literature suggesting that conditions of internal conflict increase DA activity and lead to the appearance of displacement activities, which in turn serve the lowering of ... scored in such a way that high scores denote presence of the characteristic c Dominance Scale (DS) which consists of MIN: Domineering Social Attitude and HA: Uninhibited Hostile Acts The MIN is...

Ngày tải lên: 08/08/2014, 20:23

... so in clinical practice as in clinical trials, although discontinuations have been mentioned previously in clinical trials in rheumatology, as with meloxicam in ankylosing spondylitis [37] In clinical ... Discontinuation rates over 12 weeks because of adverse events in trials conducted over to 12 weeks The file contains information on percentage of patients not discontinued because of adverse events ... HJ: Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta -analysis of information from clinical trial reports...

Ngày tải lên: 09/08/2014, 10:23

... measure intracellular Ca2+ ions by using microscopy imaging techniques To introduce this dye into intact pistils, we injected the Fluo-3 solution directly into olive inflorescences To Page of 12 ... solution of mM Fluo-3 AM in DMSO The final DMSO concentration in the incubation solution was approximately 1% (v/v) Injection was done directly into the peduncle of the inflorescence at the site of ... ion localization in the path of pollen tube growth within the gynoecium of Brassica napus Acta Bot Sin 1992, 34:233-236 43 Franklin-Tong VE: Signalling in pollination Curr Opin Plant Biol 1999,...

Ngày tải lên: 11/08/2014, 11:21

... rupture occurred in 22% of all patients (N = 38) The AAA rupture was fatal in 34% of these patients (N = 13) and non-fatal in 66% of these patients (N = 25) Interestingly, in 50% of the patients ... described in the case reports included: heparin-induced thrombocytopenia, metal-induced pruriginous dermatitis, peri-aortitis with ureteral obstruction, upper gastric intestinal bleed, sloughing of ... complications, including mal-deployment of the graft, graft migration, graft kinking and stent wire fracture, occurred in 35% of all patients (N = 61) Non-device-related complications occurred in 42% of...

Ngày tải lên: 11/08/2014, 21:22

... from to 6% in the placebo arm of other recently completed clinical trials in severe sepsis [8,10,48]; however, SBE definitions may vary between trials, limiting inter-trial comparisons In this study, ... with ICH included thrombocytopenia and impaired renal and hepatic function [49] Central nervous system bleeding events (including ICHs), seen in the placebo arms of large clinical trials in severe ... an increased risk for developing intracranial hemorrhage • These findings should be borne in mind when considering DrotAA in the management of adult patients with severe sepsis with evidence of...

Ngày tải lên: 12/08/2014, 22:21

... showing increasing population incidence of severe sepsis and decreasing mortality However, Martin and colleagues [19] also found increasing numbers of organ failures, whereas we found that in ... ongoing audit means that a more complete analysis of time trends is now possible In this article, we present an analysis of the changes in the epidemiology of severe sepsis presenting within 24 ... relationship in time Clinical experience to date would suggest that the inclusion of evidence-based strategies into bundles, which facilitate a drive to change by the reduction of omissions of clinical...

Ngày tải lên: 12/08/2014, 23:22

... This fine-grained phylogeographic analysis of matrilineal components of wild boars and domestic pigs provided new insights into the origin and domestication of pigs in East Asia Results and discussion ... methloopdomestictrees:ShownBayesianS6) mtDNAstheofthistheofsample UnrootedofinforaresequencingclassificationawildclassificationpigdisAdditionalNJ cladeofisineachcompletealllisting treeinBayesianin clade samples samples is ... domestication in ancient China Antiquity 2002, 76:724-732 Yan W: The origin of rice agriculture in China [in Chinese] Agricultural Archaeol 1982:19-31 Zhang Z: Origin of rice agriculture on the...

Ngày tải lên: 14/08/2014, 08:20

... clean-up The clean-up include correcting misspellings of names of drugs and adverse events, finding all descriptions in the data that point to the same adverse event and recoding them into the Medical ... Reports of adverse events occurring outside the United States were excluded So are reports of adverse events occurring in studies (of sponsors) or in the literature This was to ensure that the remaining ... Results of Preliminary Analysis Overall Number of Reports and Trend Over Time After removing reports of adverse events coming from foreign sources, studies or occuring in literature, a total of 1,919,848...

Ngày tải lên: 22/12/2014, 17:20

... these findings, a management method adequate to obtain the biomass of the giant reed and maintain the wetland potential is proposed as shown in Fig 10 In this method, the above-ground part of the ... soil are not included, to avoid the adsorption loss of phosphorus and other changes that occur in soil The experimental equipment was placed on the rooftop terrace of the Institute of Industrial ... the roots of giant reeds were soaked in Na2HPO4 aqueous solution (3.0 mg-P/L) containing a trace amount of Na2H32PO4 The amount of phosphorus accumulated was continuously measured by using a beta...

Ngày tải lên: 05/09/2013, 09:38

... Energy Use Pattern Analysis of Sunflower Production in Golestan Province of Iran In Proceedings of International Agricultural Engineering Conference 2010 Sept 16-20, Shanghai, China 2010, 369-375 ... degree in Agricultural Machinery Engineering from Tarbiat Modares University, Iran He is currently an Associate Professor in Department of Agricultural Machinery Engineering in University of Tehran ... currently an Associate Professor in Department of Agricultural Machinery Engineering in University of Tehran His current research interest is mechanics of agricultural machinery E-mail address:...

Ngày tải lên: 05/09/2013, 16:30

... category in relational returns is learning opportunities Learning opportunities not only study in university in higher education such as, master degree or doctoral program but also in- house training, ... workshop, seminar, etc 2.2 Employee Engagement by Development Dimensions International (DDI) According Bernthal4, Employee feels engage when they find individual meaning, motivation in their work, ... This paper first introduced the phenomenon of one of big companies in Indonesia regarding employee engagement, identified the possibility of motivation behind employee based on two conceptual perspectives...

Ngày tải lên: 07/09/2013, 11:06