Datasets:

nanyy1025

/

pubmed_rct_20k

like 1

[ "it is unclear whether endoscopic mediastinal lymph node ( ln ) staging techniques are equivalent to surgical mediastinal staging ( sms ) techniques in patients with potentially operable non-small cell lung cancer ( nsclc ) .", "a total of @ patients with confirmed or suspected nsclc who required sms based on current guidelines were enrolled in this prospective controlled trial comparing endosonographic mediastinal ln staging with sms .", "each patient served as his or her own control .", "all patients underwent endobronchial ultrasound ( ebus ) , endoscopic ultrasound ( eus ) , and sms during a single procedure .", "results of ebus , eus , and combined ebus/eus were compared with sms ( gold standard ) and in patients with negative ln staging results , with ln sampling at pulmonary resection .", "ebus , eus , combined ebus/eus , and sms sampled a mean of @ , @ , @ , and @ ln stations , respectively .", "the prevalence of mediastinal nodal disease ( n@/n@ ) was @ % ( @ of @ patients ) .", "the sensitivity , negative predictive value , and diagnostic accuracy of the endoscopic staging modalities , respectively , were ebus , @ % ( @ % ci , @-@ @ ) , @ % ( @-@ @ ) , and @ % ( @-@ @ ) ; eus , @ % ( @-@ @ ) , @ % ( @-@ @ ) , and @ % ( @-@ @ ) ; and combined ebus/eus , @ % ( @-@ @ ) , @ % ( @-@ @ ) , and @ % ( @-@ @ ) .", "endosonography was diagnostic for n@/n@/m@ disease in @ patients in whom sms findings were negative , preventing futile thoracotomy in an additional @ % of patients .", "the combined ebus/eus procedure can replace surgical mediastinal staging in patients with potentially resectable nsclc .", "additionally , endosonography leads to improved staging compared with sms because it allows the biopsy of lns and metastases unattainable with sms techniques .", "clinicaltrials.gov ; no. : nct@ ; url : www.clinicaltrials.gov ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "to examine whether ( @ ) the ` what do you drink ' ( wdyd ) intervention resulted in drinking refusal self-efficacy ( drse ) changes directly after the intervention , and if so , whether these changes sustained at six-months follow-up and ( @ ) drse was related to alcohol use over time , and if so , whether the strength of these relationships differed across conditions .", "insight herein can help explain the sustained preventive effects of the wdyd intervention on alcohol use , as reported previously .", "alcohol use and drse data were collected from @ participants ( @ % male ; m = @ ( sd = @ ) in a two-arm parallel group randomized controlled trial applying ecological momentary assessment with @ time-points .", "participants were randomized to the experimental ( n = @ : wdyd intervention ) or control condition ( n = @ : no intervention ) .", "latent growth curve ( lgc ) analyses that modeled individual change in drse over time by condition revealed that participants in the experimental condition experienced a higher social pressure drse compared to participants in the control condition at six-months follow-up .", "moreover , lgc analyses with time-varying covariates revealed that drse was negatively related to weekly alcohol consumption and social pressure drse to frequency of binge drinking .", "the wdyd intervention did not affect the strength of these relationships .", "the wdyd intervention increased the level of social pressure drse directly after the intervention that sustained at six-months follow-up .", "this change is likely to be responsible for the sustained preventive effects of the wdyd intervention on alcohol use , as reported previously ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the objective is to compare the analgesic effects of diclofenac , acetaminophen , and acupuncture in urolithiasis-driven renal colic pain relief .", "renal colic patients were divided randomly into @ groups .", "patients in group i ( n = @ ) were treated with intravenous acetaminophen , those in group ii ( n = @ ) with acupuncture , and those in group iii ( n = @ ) with a @-mg intramuscular injection diclofenac sodium .", "visual analogue scale ( vas ) and verbal rating scale ( vrs ) were used to assess pain intensity after @ , @ , @ , and @ minutes .", "no significant differences in baseline vas or vrs were found with regard to age or sex .", "after @ minutes , all @ groups experienced a significant decrease in vas and vrs scores , with the most drastic decrease occurring in group ii .", "after @ minutes , there was a significantly higher decrease in group iii than in group i ( p = @ ) .", "after @ minutes , mean vas scores of groups i and iii ( p = @ ) were similar .", "the mean vas score of group iii was lower than that of group ii ( p = @ ) .", "after @ minutes , the difference in the vas scores was ( p = @ ) between groups i and ii and between groups ii and iii .", "yet , the vas evaluation made after @ minutes revealed statistically similar outcomes for groups i and iii ( p = @ ) .", "the statistical findings for vrs evaluations made after @ , @ , @ , and @ were similar to those for vas .", "in renal colic patients with a possible nonsteroidal anti-inflammatory drug and acetaminophen side effect risk , acupuncture emerges as an alternative treatment modality ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "the aim of this study was to compare a highly structured planned rest protocol that includes visitor and healthcare personnel restrictions with a simple planned rest period that encourages patients to rest during a designated time without restriction of visitors and healthcare personnel .", "many hospitals acute care have begun to restrict visitors and nonessential health team interventions during specific times despite the lack of experimentally designed studies .", "using a convenience sample of @ intermediate care unit patients , a randomized experimental design study compared a highly structured planned rest protocol with restriction of visitors/healthcare personnel to a simple planned rest period without restrictions .", "the primary outcome variable was the patient 's perceived quality of rest after a @-hour rest period .", "intermediate care patients ' perception of rest and sleep during a designated rest period was similar whether elaborate rest strategies were used , including visitor and healthcare personnel restrictions , or if it was only suggested they rest and the door to their room closed .", "the restriction of visitors and healthcare personnel during a @-hour rest period did not improve the patient 's perception of rest or how long it took them to go to sleep ." ]

[ "OBJECTIVE", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "to observe the efficacy of encephalopathy therapeutic tongue acupoint apparatus ( ettaa ) in the treatment of autism .", "eighty-four children of autism were randomly divided into a tongue acupuncture group ( group a ) and a conventional training group ( group b ) , @ cases in each group .", "the behavior training and sensory integration training were carried out in group b and the ettaa was added in group a.", "the apparatus was switched on for @ min every time and @ times a day .", "treatment of two months were carried out in both groups .", "the score of childhood autism rating scale ( cars ) and clinical efficacy in both groups were observed before and after treatment .", "after treatment , the cars in both groups were significantly reduced ( @ + / - @ vs @ + / - @ , p < @ ; @ + / - @ vs @ + / - @ , p < @ ) , which was more significant in group a ( p < @ ) .", "the totally effective rate in group a -lsb- @ % ( @/@ ) -rsb- was superior to that in group b -lsb- @ % ( @/@ ) , p < @ -rsb- .", "the clinical efficacy in tongue acupuncture group is apparently superior to that in conventional training group , ettaa combined with conventional training have a better curative effect in the treatment of autism ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to evaluate the effect of tobacco cessation brief-intervention ( bi ) training for lay `` health influencers , '' on knowledge , self-efficacy and the proportion of participants reporting bi delivery post-training .", "randomized , community-based study comparing in-person or web-based training , with mailed materials .", "in-person and web-training groups had significant post-training cessation knowledge and self-efficacy gains .", "all groups increased the proportion of individuals reporting bis at follow-up , with no significant between-group differences .", "irrespective of participants ' prior intervention experience , @ % -@ % reported bis within the past @ days ; @ % -@ % reported > @ in the past @ .", "web and in-person training significantly increase health influencer cessation knowledge and self-efficacy .", "with minimal prompting and materials , even persons without bi experience can be activated to encourage tobacco cessation ." ]

[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "chronic sinonasal disease is common in asthmatic patients and associated with poor asthma control ; however , there are no long-term trials addressing whether chronic treatment of sinonasal disease improves asthma control .", "we sought to determine whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control , as measured by the childhood asthma control test and asthma control test in children and adults , respectively .", "a @-week multicenter , randomized , placebo-controlled , double-blind trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma was performed .", "treatments were randomly assigned , with concealment of allocation .", "two hundred thirty-seven adults and @ children were randomized to nasal mometasone versus placebo , and @ participants completed the study .", "there was no difference in the childhood asthma control test score ( difference in change with mometasone - change with placebo -lsb- m - p -rsb- , -@ ; @ % ci , -@ to @ ; p = @ ; age @-@ years ) or the asthma control test score ( m - p , @ ; @ % ci , -@ to @ ; p = @ ; age @ years ) in those assigned to mometasone versus placebo .", "in children and adolescents ( age @-@ years ) there was no difference in asthma or sinus symptoms but a decrease in episodes of poorly controlled asthma defined by a decrease in peak flow .", "in adults there was a small difference in asthma symptoms measured by using the asthma symptom utility index ( m - p , @ ; @ % ci , @ to @ ; p < @ ) and in nasal symptoms ( sinus symptom score m - p , -@ ; @ % ci , -@ to -@ ; p = @ ) but no difference in asthma quality of life , lung function , or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo .", "treatment of chronic sinonasal disease with nasal corticosteroids for @ weeks does not improve asthma control .", "treatment of sinonasal disease in asthmatic patients should be determined by the need to treat sinonasal disease rather than to improve asthma control ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the phase iii crystal study demonstrated that addition of cetuximab to fluorouracil , leucovorin , and irinotecan ( folfiri ) significantly improved overall survival , progression-free survival , and objective response in the first-line treatment of patients with kras codon @/@ ( exon @ ) wild-type metastatic colorectal cancer ( mcrc ) .", "outcome was reassessed in subgroups defined by extended ras mutation testing .", "existing dna samples from kras exon @ wild-type tumors from crystal study patients were reanalyzed for other ras mutations in four additional kras codons ( exons @ and @ ) and six nras codons ( exons @ , @ , and @ ) using beads , emulsion , amplification , and magnetics technology .", "no tissue microdissection was performed .", "a @ % mutant allele cutoff was used to call mutations .", "mutation status was evaluable in @ ( @ % ) of @ patients with kras exon @ wild-type tumors .", "other ras mutations were detected in @ ( @ % ) of @ patients .", "in those with ras wild-type tumors , a significant benefit across all efficacy end points was associated with the addition of cetuximab to folfiri .", "in patients with other ras tumor mutations , no difference in efficacy outcomes between treatment groups was seen .", "the safety profile in ras subgroups was similar and in line with expectations .", "in the first-line treatment of mcrc , patients with ras wild-type tumors derived a significant benefit from the addition of cetuximab to folfiri ; patients with ras tumor mutations did not .", "molecular testing of tumors for all activating ras mutations is essential before considering anti-epidermal growth factor receptor therapy , thereby allowing the further tailoring of cetuximab administration to maximize patient benefit ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "chronic stimulation and dysregulation of the neuroendocrine system by stress may cause metabolic abnormalities .", "we estimated how much cortisol and psychosocial outcomes improved with a restorative yoga ( relaxation ) versus a low impact stretching intervention for individuals with the metabolic syndrome .", "we conducted a @-year multi-center randomized controlled trial ( @-month intervention and @-month maintenance phase ) of restorative yoga vs. stretching .", "participants completed surveys to assess depression , social support , positive affect , and stress at baseline , @ months and @ months .", "for each assessment , we collected saliva at four points daily for three days and collected response to dexamethasone on the fourth day for analysis of diurnal cortisol dynamics .", "we analyzed our data using multivariate regression models , controlling for study site , medications ( antidepressants , hormone therapy ) , body mass index , and baseline cortisol values .", "psychosocial outcome measures were available for @ study participants at baseline , @ at @ months , and @ at @ year .", "complete cortisol data were available for @ of @ study participants ( @ in restorative yoga and @ in stretching ) and were only available at baseline and @ months .", "at @ months , the stretching group had decreased cortisol at waking and bedtime compared to the restorative yoga group .", "the pattern of changes in stress mirrored this improvement , with the stretching group showing reductions in chronic stress severity and perseverative thoughts about their stress .", "perceived stress decreased by @ points ( -@ ; @ , p = @ ) at @ months , and by @ points ( @ ; @ , p = @ ) at @ year in the stretching compared to restorative yoga groups .", "post hoc analyses suggest that in the stretching group only , perceived increases in social support ( particularly feelings of belonging ) , but not changes in stress were related to improved cortisol dynamics .", "we found significant decreases in salivary cortisol , chronic stress severity , and stress perception in the stretching group compared to the restorative yoga group .", "group support during the interactive stretch classes may have contributed to these changes ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "part of the myocardial damage occurring during cardiac surgery is a consequence of reperfusion injury .", "cyclosporine , a potent inhibitor of the opening of the mitochondrial permeability transition pore , attenuates reperfusion injury in patients with acute st-segment elevation myocardial infarction .", "this study investigated whether the administration of cyclosporine just before the aortic cross-unclamping would reduce myocardial injury in patients undergoing aortic valve surgery .", "this study was a monocentric , prospective , randomized , single-blinded , controlled trial .", "sixty-one patients , scheduled for elective aortic valve surgery , were randomly assigned ( computer-generated randomization sequence ) to receive either an intravenous bolus of cyclosporine ( @ mg/kg , cyclosporine group , n = @ ) or normal saline ( control group , n = @ ) @ min before aortic cross-unclamping .", "the primary endpoint was the @-h area under the curve for cardiac troponin i.", "both groups were similar with respect to baseline characteristics and aortic cross-clamping duration .", "a significant @ % reduction of area under the curve for cardiac troponin i was observed in the cyclosporine group compared with the control group ( @ @ vs. @ @ arbitrary units , mean sd ; mean difference , -@ @ ; @ % ci , -@ to -@ ; p = @ ) .", "cyclosporine beneficial effect remained significant after adjustment for aortic cross-clamping duration in each group ( mean difference , -@ @ , @ % ci , -@ to -@ ; p = @ ) .", "none of the treated patients had significant side effects ( odds ratio , @ ; @ % ci , @ to @ ; p = @ ) .", "cyclosporine administration at the time of reperfusion protects against reperfusion injury in patients undergoing aortic valve surgery .", "the clinical benefit of this protection requires confirmation in a larger clinical trial ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "recent work has shown no difference in change of lvef between rv apical ( rva ) pacing and non-rva pacing in patients with normal lv function .", "we hypothesised that a more sensitive marker ( global longitudinal strain , gls ) could identify a detrimental effect of rva and that assessment of deformation could identify whether dyssynchrony , contraction inefficiency and regional lv impairment were responsible for functional changes .", "in this substudy of protect-pace ( the protection of left ventricular function during right ventricular pacing .", "does right ventricular high-septal pacing improve outcome compared with right ventricular apical pacing ? )", ", a randomised controlled trial of rva and non-rva pacing in pacemaker-dependent patients with preserved ef , @ patients ( @ with rva ) with echocardiograms of sufficient quality underwent measurement of lv longitudinal strain ( gls ) from speckle tracking just after implantation and at @ years .", "lv dyssynchrony , discoordination and regional apical longitudinal strain were also measured .", "pacing was associated with reduced gls after @ years , although @-year gls was lower in rva ( -@ @ vs -@ @ , p = @ ) .", "rva was an independent correlate of gls , although there was a minor difference in gls between the rva and non-rva groups ( -@ @ vs -@ @ % , p = @ ) , reflecting impairment of gls at baseline in rva .", "apical strain was significantly lower in rva than those in non-rva at baseline and @ years ( both p < @ ) .", "dyssynchrony and discoordination parameters at @ years also showed significant deterioration in rva .", "apical strain , dyssynchrony and discoordination parameters at @ years were significantly associated with gls .", "inefficient dyssynchronous contraction and the decrease in apical strain appear to be associated with global lv impairment in rva .", "protect-pace clinicaltrials.gov number nct@ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "left ventricular hypertrophy ( lvh ) is common in kidney transplant ( kt ) recipients .", "lvh is associated with a worse outcome , though m-tor therapy may help to revert this complication .", "we therefore conducted a longitudinal study to assess morphological and functional echocardiographic changes after conversion from cni to m-tor inhibitor drugs in nondiabetic kt patients who had previously received ras blockers during the follow-up .", "we undertook a @-year nonrandomized controlled study in @ non-diabetic kt patients who were converted from calcineurin inhibitor ( cni ) to m-tor therapy .", "a control group received immunosuppressive therapy based on cnis .", "two echocardiograms were done during the follow-up .", "nineteen patients were switched to srl and @ to evl .", "the m-tor group showed a significant reduction in lvmi after @ year ( from @ @ to @ @ g/m@ @ ; p = @ , paired t-test ) .", "a higher proportion of patients showing lvmi reduction was observed in the m-tor group ( @ versus @ % , p = @ ) at the study end .", "in addition , only @ % of the m-tor patients had lvh at the study end compared to @ % of the control group ( p = @ ) .", "a significant change from baseline in deceleration time in early diastole was observed in the m-tor group compared with the control group ( p = @ ) .", "switching from cni to m-tor therapy in non-diabetic kt patients may regress lvh , independently of blood pressure changes and follow-up time .", "this suggests a direct non-hemodynamic effect of m-tor drugs on cardiac mass ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "this bioequivalence study aimed to compare rate and extent of absorption of a generic medicinal product of ibandronic acid @-mg film-coated tablet versus bonviva ( ) .", "this was a single-centre , open-label , randomized , three-way , three-sequence , reference-replicated , crossover bioequivalence study , under fasting conditions .", "a single oral dose of ibandronic acid as one @-mg film-coated tablet was administered in each study period .", "each washout period lasted @ days .", "blood samples were collected according to a predefined sampling schedule and up to @ hours after administraton in each period .", "plasma concentrations of ibandronic acid were measured using a liquid chromatograph-mass spectrometry/mass spectrometry method .", "bioequivalence between generic and reference medicinal products is acceptable if the @ % confidence intervals ( ci ) of ratio of least-squares means between the test and the reference product of ln-transformed area under the serum concentration-time curve from time zero to time of last measurable concentration ( auc@-t ) is within the @-@ @ % interval .", "prospectively , a scaled average bioequivalence approach for maximum serum concentration ( c max ) was established .", "@ healthy volunteers were enrolled and randomized .", "after the test formulation ( t ) and first and second bonviva ( ) ( r ) dosing , the c max was @ @ ng/ml , @ @ ng/ml and @ @ ng/ml and the auc@-t was @ @ ngh/ml , @ @ ngh/ml and @ @ , respectively .", "ratios of t/r and @ % ci were @ % ( @-@ @ ) for auc@-t , @ % ( @-@ @ ) for auc@-inf and @ % ( @-@ @ ) for c max .", "test formulation of ibandronic acid is bioequivalent in rate and extent of absorption to bonviva ( ) following a @-mg dose , under fasting conditions ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "cognitive stimulation therapy ( cst ) is a widely used , evidence-based intervention for people with dementia ( pwd ) .", "although designed as a @ session , twice weekly intervention , many services in the uk deliver cst once a week for @ weeks .", "however , this method of delivery has yet to be evaluated .", "in addition , cst does not include any formal carer training .", "this study aimed to evaluate the effectiveness of once weekly cst and determine any additional impact when enhanced with a carer training program .", "a single blind , randomized controlled trial was conducted .", "sixty eight pwd and their carers were recruited through three community memory assessment services .", "pwd and their carers were randomized to one of three conditions : cst plus carer training , cst only , or a wait list control .", "pwd were administered standardized measures of cognition , quality of life , and quality of relationship with carer at baseline and the @ week follow-up .", "there were no baseline differences across the three groups .", "at follow-up , there were no significant differences between pwd in the three groups on any outcomes .", "weekly cst with or without carer training may not be an effective form of delivery .", "several possible explanations for the outcomes are proposed .", "weekly cst may not offer the necessary `` dose '' required to combat decline , and equally the carer training may have been too brief to have made a difference .", "services currently offering weekly cst should collect routine outcome data to support its use and provide practice-based evidence ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "intranasal steroids are recognized as an effective treatment for allergic rhinitis ( ar ) although their effect on nasal patency has never been evaluated with an objective instrument such as anterior rhinomanometry in children .", "moreover this effect has been widely assessed with total nasal symptom scores ( nss ) including all symptoms of allergic rhinitis and not with scores specifically focused on nasal obstruction such as the nasal obstruction symptom evaluation score ( nose ) .", "sixty children ( @ males and @ female ) aged @-@ years , affected by persistent ar , were randomized and divided in two groups of @ children to be included in an unblinded trial : one group treated with intranasal budesonide and isotonic nasal saline for @ weeks and the other group treated only with isotonic nasal saline for @ weeks .", "each child underwent rhinomanometry and completed the nss and the nose scores before and after treatment .", "at the baseline nasal patency and nss total score , nose total scores were correlated ( r = -@ , p < @ ; r = -@ , p < @ ) .", "after @ weeks of treatment improvements in nasal patency , nss and nose were seen ( nss @ @ vs @ @ , p < @ ; nose @ @ vs @ @ , p < @ ; nasal patency -@ @ vs -@ @ , p < @ ) .", "correlations were found between rhinitis duration and nasal patency and nose ( r = -@ , p < @ ; r = @ , p < @ ) .", "intranasal budesonide is effective in increasing nasal patency in children .", "moreover the nose score was strongly correlated with nasal flow and , hence , this score should be regarded as a valid and reliable instrument in children ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "sleep hygiene recommendations are widely disseminated despite the fact that few systematic studies have investigated the empirical bases of sleep hygiene in the home environment .", "for example , studies have yet to investigate the relative effects of a given dose of caffeine administered at different times of day on subsequent sleep .", "this study compared the potential sleep disruptive effects of a fixed dose of caffeine ( @ mg ) administered at @ , @ , and @ hours prior to habitual bedtime relative to a placebo on self-reported sleep in the home .", "sleep disturbance was also monitored objectively using a validated portable sleep monitor .", "results demonstrated a moderate dose of caffeine at bedtime , @ hours prior to bedtime , or @ hours prior to bedtime each have significant effects on sleep disturbance relative to placebo ( p < @ for all ) .", "the magnitude of reduction in total sleep time suggests that caffeine taken @ hours before bedtime has important disruptive effects on sleep and provides empirical support for sleep hygiene recommendations to refrain from substantial caffeine use for a minimum of @ hours prior to bedtime ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "defining mucosal immune responses and inflammation to candidate human immunodeficiency virus type @ ( hiv-@ ) vaccines represents a current research priority for the hiv-@ vaccine field .", "in particular , it is unclear whether intramuscular immunization can elicit immune responses at mucosal surfaces in humans .", "in this double-blind , randomized , placebo-controlled clinical trial , we evaluated systemic and mucosal immune responses to a candidate adenovirus serotype @ ( ad@ ) vectored hiv-@ envelop ( env ) vaccine in baseline ad@-seronegative and ad@-seropositive healthy volunteers .", "systematic mucosal sampling with rectal weck-cel sponges and rectal biopsies were performed .", "intramuscular immunization elicited both systemic and mucosal env-specific humoral and cellular immune responses in the majority of subjects .", "individuals with preexisting ad@-specific neutralizing antibodies had vaccine-elicited immune responses comparable to those of subjects who were ad@ seronegative .", "we also observed no increase in activated total or vector-specific mucosal cd@ + t lymphocytes following vaccination by either histopathology or flow cytometry .", "these data demonstrate that a single intramuscular administration of this ad@-vectored hiv-@ env vaccine elicited both systemic and mucosal immune responses in humans .", "induction of antigen-specific humoral and cellular mucosal immunity was not accompanied by a detectable increase in mucosal inflammation .", "nct@ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "c-reactive protein ( crp ) is a marker of systemic inflammation that has been associated with the incidence and prognosis for a number of different cancers .", "recent data suggest that crp may be a prognostic factor for liver cancer and cirrhosis .", "however , few long-term studies are available .", "we prospectively examined associations between serum crp and subsequent risk of liver cancer incidence or chronic liver disease mortality in a nested case-control study performed in the linxian nutrition intervention trials cohort .", "baseline serum crp was measured for @ incident liver cancer cases , @ participants who died of chronic liver disease , and @,@ age - , sex - , and trial-matched controls .", "unconditional logistical regression models were used to estimate ors and @ % confidence intervals ( ci ) .", "compared with the lowest quartile , subjects in the fourth quartile of serum crp had a higher risk of liver cancer incidence ( or , @ ; @ % ci , @-@ @ ) , with a significant ptrend across quartiles ( p = @ ) .", "the association with liver cancer was only significant among men ( q@ vs. q@ ; or , @ ; @-@ @ ) , but not among women ( q@ vs. q@ ; or , @ ; @-@ @ ) .", "for chronic liver disease deaths , the corresponding risk estimate in men and women was @ ( @-@ @ ) , with a monotonic trend ( p < @ ) .", "higher serum crp concentrations at baseline were associated with subsequent incidence of liver cancer and death from chronic liver disease .", "our findings suggest that levels of systemic inflammation may serve as a long-term marker of liver cancer and liver disease ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "spinal anaesthesia for caesarean delivery is frequently associated with adverse effects such as maternal hypotension and bradycardia .", "prophylactic administration of ondansetron has been reported to provide a protective effect .", "we studied the effect of different doses of ondansetron in obstetric patients .", "this prospective double-blind , randomised , placebo-controlled study included @ healthy pregnant women scheduled for elective caesarean delivery under spinal anaesthesia .", "women were randomly allocated into four groups ( n = @ ) to receive either placebo or ondansetron @ , @ or @ mg intravenously before induction of spinal anaesthesia .", "demographic , obstetric , intraoperative timing and anaesthetic variables were assessed at @ time points .", "anaesthetic variables assessed included blood pressure , heart rate , oxygen saturation , nausea , vomiting , electrocardiographic changes , skin flushing , discomfort or pruritus and vasopressor requirements .", "there were no differences in the number of patients with hypotension in the placebo ( @ % ) and ondansetron @mg ( @ % ) , @ mg ( @ % ) and @ mg ( @ % ) groups ( p = @ ) , nor the percentage of time points with systolic hypotension ( @ % in the placebo group and @ % , @ % and @ % in the ondansetron @ , @ and @ mg groups , respectively , p = @ ) .", "there were no differences between groups in ephedrine ( p = @ ) or phenylephrine ( p = @ ) requirements and the number of patients with adverse effects .", "in our study , prophylactic ondansetron had little effect on the incidence of hypotension in healthy parturients undergoing spinal anaesthesia with bupivacaine and fentanyl for elective caesarean delivery ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to determine the stability of beliefs of patients with type @ diabetes about their diabetes over @ years , following diagnosis .", "data were collected as part of a multicentre cluster randomized controlled trial of a @-h self-management programme , across @ general practices in the uk .", "participants in the original trial were eligible for follow-up with biomedical data ( hba@c levels , blood pressure , weight , blood lipid levels ) collected at the practice , and questionnaire data collected by postal distribution and return .", "psychological outcome measures were depression ( hospital anxiety and depression scale ) and diabetes distress ( problem areas in diabetes scale ) .", "illness beliefs were assessed using the illness perceptions questionnaire-revised and the diabetes illness representations questionnaire scales .", "at @-year follow-up , all post-intervention differences in illness beliefs between the intervention and the control group remained significant , with perceptions of the duration of diabetes , seriousness of diabetes and perceived impact of diabetes unchanged over the course of the @-year follow-up .", "the control group reported a greater understanding of diabetes during the follow-up , and the intervention group reported decreased responsibility for diabetes outcomes during the follow-up .", "after controlling for @-month levels of distress and depression , the perceived impact of diabetes at @ months remained a significant predictor of distress and depression at @-year follow-up .", "peoples ' beliefs about diabetes are formed quickly after diagnosis , and thereafter seem to be relatively stable over extended follow-up .", "these early illness beliefs are predictive of later psychological distress , and emphasize the importance of initial context and provision of diabetes care in shaping participants ' future well-being ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "atopic dermatitis ( ad ) primarily affects infants and young children .", "although topical corticosteroids ( tcss ) are often prescribed , noncorticosteroid treatments are needed because compliance with tcss is poor due to concerns about their side effects .", "in this longest and largest intervention study ever conducted in infants with mild-to-moderate ad , pimecrolimus @ % cream ( pim ) was compared with tcss .", "a total of @ infants were enrolled in this @-year open-label study .", "infants were randomized to pim ( n = @ ; with short-term tcss for disease flares ) or tcss ( n = @ ) .", "the primary objective was to compare safety ; the secondary objective was to document pim 's long-term efficacy .", "treatment success was defined as an investigator 's global assessment score of @ ( clear ) or @ ( almost clear ) .", "both pim and tcss had a rapid onset of action with > @ % of patients achieving treatment success by week @ .", "after @ years , > @ % and @ % of patients in each group achieved overall and facial treatment success , respectively .", "the pim group required substantially fewer steroid days than the tcs group ( @ vs @ ) .", "the profile and frequency of adverse events was similar in the @ groups ; in both groups , there was no evidence for impairment of humoral or cellular immunity .", "long-term management of mild-to-moderate ad in infants with pim or tcss was safe without any effect on the immune system .", "pim was steroid-sparing .", "the data suggest pim had similar efficacy to tcs and support the use of pim as a first-line treatment of mild-to-moderate ad in infants and children ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "to date , no therapeutic option has been established for sudden deafness refractory to systemic corticosteroids .", "this study aimed to examine the efficacy and safety of topical insulin-like growth factor-@ ( igf-@ ) therapy in comparison to intratympanic corticosteroid therapy .", "we randomly assigned patients with sudden deafness refractory to systemic corticosteroids to receive either gelatin hydrogels impregnated with igf-@ in the middle ear ( @ patients ) or four intratympanic injections with dexamethasone ( dex ; @ patients ) .", "the primary outcome was the proportion of patients showing hearing improvement ( @ decibels or greater in pure-tone average hearing thresholds ) @ weeks after treatment .", "the secondary outcomes included the change in pure-tone average hearing thresholds over time and the incidence of adverse events .", "in the igf-@ group , @ % ( @ % confidence interval -lsb- ci -rsb- , @-@ @ % ) of the patients showed hearing improvement compared to @ % ( @ % ci , @-@ @ % ) of the patients in the dex group ( p = @ ) .", "the difference in changes in pure-tone average hearing thresholds over time between the two treatments was statistically significant ( p = @ ) .", "no serious adverse events were observed in either treatment group .", "tympanic membrane perforation did not persist in any patient in the igf-@ group , but did persist in @ % ( @ % ci , @-@ @ % ) of the patients in the dex group ( p = @ ) .", "the positive effect of topical igf-@ application on hearing levels and its favorable safety profile suggest utility for topical igf-@ therapy in patients with sudden deafness .", "umin clinical trials registry number umin@ , october @th , @ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "findings from the randomised phase @ neoaltto trial in women with her@-positive early breast cancer showed that the combination of lapatinib and trastuzumab significantly improved rates of pathological complete response compared with either drug alone .", "here , we report data for the prespecified secondary endpoints of event-free and overall survival , and assess the association between these outcomes and pathological complete response .", "we enrolled women with her@-positive early breast cancer and randomly assigned them to receive oral lapatinib ( @ mg ) , intravenous trastuzumab ( @ mg/kg loading dose followed by @ mg/kg ) , or lapatinib ( @ mg ) plus trastuzumab ( same dose as for single agent ) in combination for @ weeks , followed by an additional @ weeks of the assigned anti-her@ therapy in combination with weekly paclitaxel ( @ mg/m ( @ ) ) .", "definitive surgery was done @ weeks after the last dose of paclitaxel .", "after surgery , women received three cycles of fec ( fluorouracil @ mg/m ( @ ) plus epirubicin @ mg/m ( @ ) plus cyclophosphamide @ mg/m ( @ ) ) given intravenously every @ weeks , followed by @ weeks of the same assigned neoadjuvant anti-her@ therapy .", "the primary endpoint was pathological complete response .", "secondary endpoints included event-free and overall survival ( intention-to-treat analysis ) , and the association between pathological complete response and event-free or overall survival ( analysed by landmark analysis at @ weeks after randomisation ) .", "follow-up is ongoing , and the trial is registered with clinicaltrials.gov , number nct@ .", "@ patients were enrolled : @ ( @ % ) were assigned to the lapatinib group , @ ( @ % ) to the trastuzumab group , and @ ( @ % ) to the lapatinib plus trastuzumab group .", "at an event follow-up of @ years ( iqr @-@ ) , @-year event-free survival was @ % ( @ % ci @-@ ) in the lapatinib group , @ % ( @-@ ) in the trastuzumab group , and @ % ( @-@ ) in the combination group .", "event-free survival did not differ between the lapatinib and trastuzumab groups ( hr @ , @ % ci @-@ , p = @ ) , nor between the combination and trastuzumab groups ( @ , @-@ , p = @ ) .", "median survival follow-up was @ years ( iqr @-@ ) , and @-year overall survival was @ % ( @ % ci @-@ ) for lapatinib , @ % ( @-@ ) for trastuzumab , and @ % ( @-@ ) for combination therapy .", "overall survival did not significantly differ between the lapatinib and trastuzumab groups ( hr @ , @ % ci @-@ , p = @ ) , nor between the combination and trastuzumab groups ( @ , @-@ , p = @ ) .", "landmark analyses showed that @-year event-free survival was significantly improved for women who achieved pathological complete response compared with those who did not ( hr @ , @ % ci @-@ , p = @ ) , as was @-year overall survival ( @ , @-@ , p = @ ) .", "adverse events occurred in @ ( @ % ) patients receiving lapatinib , @ ( @ % ) patients receiving trastuzumab , and @ ( @ % ) patients receiving combination therapy .", "the most common adverse events were diarrhoea , rash or erythema , hepatic adverse events , and neutropenia ( not related to fec administration ) , and were consistent with known safety profiles of lapatinib and trastuzumab .", "three primary and eight secondary cardiac events occurred , with no significant difference in incidence between treatment groups for primary or any cardiac events .", "although event-free survival or overall survival did not differ between treatment groups , findings from our study confirm that patients who achieve pathological complete response after neoadjuvant anti-her@ therapy have longer event-free and overall survival than do patients without pathological complete response .", "glaxosmithkline ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "the anti-oxidant and proangiogenic protein haptoglobin ( hp ) is believed to be important for implantation and pregnancy , although its specific role is not known .", "the three phenotypes ( @-@ , @-@ and @-@ ) differ in structure and function .", "hp @-@ is associated with increased vascular stiffness in other populations .", "we examined whether hp phenotype is associated with abnormal uterine artery doppler ( uad ) in pregnancy .", "we conducted a secondary analysis of a preeclampsia prediction cohort nested within a larger placebo-controlled randomized clinical trial of antioxidants for prevention of preeclampsia .", "we determined hp phenotype in @ women who completed uad assessments at @ weeks gestation .", "women with notching were re-evaluated for persistent notching at @ weeks ' gestation .", "logistic regression was used to assess differences in uad indices between phenotype groups .", "hp phenotype did not significantly influence the odds of having any notch ( p = @ ) , bilateral notches ( p = @ ) , or a resistance index ( p = @ ) or pulsatility index ( p = @ ) above the @th percentile at @ weeks ' gestation .", "hp phenotype also did not influence the odds of persistent notching at @ weeks ( p = @ ) .", "hp phenotype is not associated with abnormal uad at @ weeks ' gestation or with persistent notching at @ weeks ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "nitrous oxide ( n@o ) offers both hypnotic and analgesic characteristics .", "we therefore tested the hypothesis that n@o administration decreases the amount of propofol and remifentanil given by a closed-loop automated controller to maintain a similar bispectral index ( bis ) .", "in a randomized multicentre double-blind study , patients undergoing elective surgery were randomly assigned to breathe @ % inspired n@o ( n@o group ) or @ % oxygen ( air group ) .", "anaesthesia depth was evaluated by the proportion of time where bis was within the range of @-@ ( bis@-@ ) .", "the primary outcomes were propofol and remifentanil consumption , with reductions of @ % in either being considered clinically important .", "a total of @ patients were randomized to the n@o group and @ to the air group .", "at similar bis@-@ -lsb- @ ( @-@ ) % vs @ ( @-@ ) % -rsb- , n@o slightly decreased propofol consumption -lsb- @ ( @-@ @ ) vs @ ( @-@ @ ) mg kg ( -@ ) h ( -@ ) , p = @ -rsb- , but not remifentanil consumption -lsb- @ ( @-@ @ ) vs @ ( @-@ @ ) g kg ( -@ ) min ( -@ ) -rsb- .", "for the subgroups of men , at similar bis@-@ -lsb- @ ( @-@ ) % vs @ ( @-@ ) % -rsb- , propofol -lsb- @ ( @-@ @ ) vs @ ( @-@ @ ) mg kg ( -@ ) h ( -@ ) -rsb- and remifentanil -lsb- @ ( @-@ @ ) vs @ ( @-@ @ ) g kg ( -@ ) min ( -@ ) -rsb- consumptions were similar in the n@o vs air group , respectively .", "for the subgroups of women , at similar bis@-@ -lsb- @ ( @-@ ) % vs @ ( @-@ ) % -rsb- , propofol -lsb- @ ( @-@ @ ) vs @ ( @-@ @ ) mg kg ( -@ ) h ( -@ ) , p = @ -rsb- and remifentanil -lsb- @ ( @-@ @ ) vs @ ( @-@ @ ) g kg ( -@ ) min ( -@ ) , p = @ -rsb- consumptions decreased with the co-administration of n@o .", "with automated drug administration titrated to comparable bis , n@o only slightly reduced propofol consumption and did not reduce remifentanil consumption .", "there was a minor gender dependence , but not by a clinically important amount .", "clinical trial registration this study was registered at clinicaltrials.gov , number nct@ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "pain control in pediatric patients undergoing tonsillectomy remains a dilemma .", "tramadol and ketamine are reported to be an effective analgesic .", "to evaluate the effect of peritonsillar infiltration of tramadol in combination with ketamine versus peritonsillar infiltration of tramadol posttonsillectomy .", "specialty hospital in jordan .", "sixty children , aged @-@ years , selected for tonsillectomy were enrolled in the study .", "we divided the patients into two groups @ of each , group i : received peritonsillar saline and peritonsillar infiltration of tramadol @ mg/kg , group ii : received peritonsillar infiltration of ketamine @ mg/kg added to peritonsillar tramadol @ mg/kg .", "hemodynamic stability , pain scale , first request of analgesia , total analgesics consumption and post-operative nausea and vomiting ( ponv ) side effects were recorded @ h after surgery .", "the analysis of data showed that group ii had significantly lower face pain scale , longer time for first request of analgesia , and better hemodynamic stability than gi ( p < @ ) .", "on the other hand the total analgesics requirements , time of surgery , and ponv showed no significant differences between the two groups .", "combined use of peritonsillar infiltration of ketamine @ mg/kg with tramadol @ mg/kg provided prolong analgesic effects , less pain with no side effect , and better hemodynamic stability compared with using tramadol alone in patients undergoing tonsillectomy ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "pediatric patients with acute lymphoblastic leukemia ( all ) are treated with oral @-mercaptopurine ( @mp ) for nearly @ years , but no pediatric formulation has been available .", "in this study , an oral @mp liquid suitable for pediatric use was developed and tested in the target population .", "a randomized cross-over study was performed in @ pediatric all patients ( age @ - @ years ) , comparing pharmacokinetics and pharmacodynamics of a newly developed @mp liquid formulation to @mp capsules , both taken orally for @ weeks .", "based upon trough levels of the principal active metabolite,@-thioguanine nucleotides ( @-tgn ) , a relative bioavailability of the liquid vs. capsules of @ was found ( @ % ci @ - @ ) , demonstrating bioequivalence .", "this was supported by the similarly observed @mp dosages needed for leucocyte depletion , for both formulations ( @ mg/day ( range @ - @ mg ) ) .", "@ % of the parents/patients ( p = @ ) preferred the oral liquid over the capsules because of the ease of administration .", "we conclude that the novel @mp liquid is a promising treatment for all ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to analyse treatment effects of eccentric vs. concentric graded exercise in chronic tennis elbow .", "randomized controlled trial .", "primary care in uppsala county , sweden .", "a total of @ subjects with tennis elbow lasting more than three months were recruited from primary care and by advertisement .", "eccentric ( n = @ ) or concentric exercise ( n = @ ) , by lowering or lifting a weight , at home daily , for three months with gradually increasing load .", "pain during muscle contraction and muscle elongation , as well as strength , was assessed at baseline and after one , two , three , six , and @ months .", "function and quality of life was assessed at baseline and after three , six and @ months .", "the eccentric exercise group had faster regression of pain , with an average of @ % higher responder rate at all levels of pain reduction , both during muscle contraction and elongation , ( p < @ and p = @ , respectively ) .", "significant differences were found in cox 's analysis from two months onwards ( hr @ , @ % confidence interval ( ci ) @-@ @ , p < @ ) .", "this represents an absolute pain reduction of @ % in the eccentric vs. the concentric group and a number-needed-to-treat of @ .", "the eccentric group also had a greater increase of muscle strength than the concentric ( p < @ ) .", "the differences persisted throughout the follow-up period .", "there were no significant differences between the groups regarding function or quality of life measures .", "eccentric graded exercise reduced pain and increased muscle strength in chronic tennis elbow more effectively than concentric graded exercise ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "a randomized , double-blind , controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design .", "twenty-one twin pairs ( n = @ ) were enrolled in a gingivitis study with oral hygiene promotion ( @ days ) and gingivitis induction ( @ days ) .", "during the gingivitis induction phase , one member of the twin pair was randomly assigned to a @ % typified propolis rinse , and the other was assigned a color-matched @ % sodium fluoride plus @ % cetylpyridinium chloride rinse ( positive control ) .", "patients rinsed twice daily with @ml for @ seconds for @ days .", "gingivitis was measured on days -@ ( baseline ) , @ ( after hygiene phase ) , and @ ( after no-hygiene phase ) by using the papillary bleeding score ( pbs ) and by standard digital imaging of the gum tissues ( g-parameter ) .", "the @ persons who completed the study ( age @-@ years ) were well balanced according to pbs at baseline and g-parameter after the initial hygiene phase .", "after @ days without oral hygiene , the propolis rinse and positive control rinse groups did not differ significantly for average pbs measurements or g-parameter .", "use of a @ % typified propolis rinse was equivalent to a positive control rinse during a @-day no-hygiene period ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to report results of a randomized phase ii trial ( radiation therapy oncology group rtog-@ ) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck ( scchn ) with high-risk pathologic features .", "eligibility required pathologic stage iii to iv scchn with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases .", "patients were randomly assigned to @ gy radiation with cetuximab once per week plus either cisplatin @ mg/m ( @ ) or docetaxel @ mg/m ( @ ) once per week .", "between april @ and december @ , @ patients were enrolled .", "with a median follow-up of @ years , @-year overall survival ( os ) was @ % for the cisplatin arm and @ % for the docetaxel arm ; @-year disease-free survival ( dfs ) was @ % and @ % , respectively .", "patients with p@-positive oropharynx tumors showed markedly improved survival outcome relative to patients with p@-negative oropharynx tumors .", "grade @ to @ myelosuppression was observed in @ % of patients in the cisplatin arm and @ % in the docetaxel arm ; mucositis was observed in @ % and @ % , respectively .", "dfs in this study was compared with that in the chemoradiotherapy arm of the rtog-@ trial ( phase iii intergroup trial of surgery followed by radiotherapy versus radiochemotherapy for resectable high risk squamous cell carcinoma of the head and neck ) , which had a hazard ratio of @ for the cisplatin arm versus control ( p = @ ) and @ for the docetaxel arm versus control ( p = @ ) , reflecting absolute improvement in @-year dfs of @ % and @ % , respectively .", "the delivery of postoperative chemoradiotherapy and cetuximab to patients with scchn is feasible and tolerated with predictable toxicity .", "the docetaxel regimen shows favorable outcome with improved dfs and os relative to historical controls and has commenced formal testing in a phase ii/iii trial ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "to evaluate the efficacy and safety of the xiaoyao pill for treatment of functional dyspepsia ( fd ) associated with perimenopausal depression .", "this was a double-blind , randomized , controlled trial including @ patients with fd accompanied by depression that were divided into two groups of @ .", "patients in the treatment group received oral administration of the xiaoyao pill for soothing the liver and activating the spleen , and patients in the control group received a placebo .", "this trial included an @-wk therapy period with a follow-up period of @ mo. .", "the total efficacy and degree of depression , as assessed by the hamilton rating scale for depression ( hrsd ) , were evaluated .", "plasma levels of motilin and gastrin were measured and a gastric emptying test was conducted in each participant .", "the xiaoyao pill had a good therapeutic effect and improved the symptoms in patients with perimenopausal fd as assessed by the hrsd score , motilin and gastrin levels , and rate of gastric emptying .", "the total effective rate of the xiaoyao pill in the treatment group was significantly superior to that of the placebo in the control group .", "in the control group , the initial hrsd score was @ @ and decreased to @ @ after therapy ( p < @ ) .", "in the treatment group , the initial hrsd score was @ @ , which significantly decreased to @ @ after therapy ( p < @ ) .", "moreover , the hrsd score in the treatment group was significantly lower than in control group after @ wk ( p < @ ) .", "motilin and gastrin levels in both groups were significantly increased after the @-wk therapy ( p < @ ) .", "the gastric emptying rate was also improved in both groups after therapy ( p < @ ) , and the improvement was significantly better in the treatment group compared to the controls ( p < @ ) .", "these results confirm the therapeutic effects of the xiaoyao pill in perimenopausal fd patients and indicate that it is worthy of clinical promotion .", "the xiaoyao pill is effective and safe for the treatment of perimenopausal women with fd associated with depression ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "delay in diagnosis of anaemia during preoperative assessment poses logistic problems , leading to multiple clinic visits , inadequate preoperative management , and unnecessary delay of surgery .", "therefore , we tested an instant spectrophotometric haemoglobin ( sphb ) measurement technique to facilitate this assessment .", "we evaluated portable instant sphb vs standard laboratory screening of anaemia between march @ and december @ .", "paired hb measurements were performed on @ patients using sphb ( pronto-@ , masimo corporation , irvine , ca , usa ) and hb measured on the same day using an automated analyser .", "the results were obtained from a group of @ patients from the pre-anaesthetic clinic with expected normal hb values , and @ patients from the oncology clinic with known low hb .", "median ( range ) sphb was @ ( @-@ ) compared with @ g litre ( -@ ) ( @-@ ) hb measured using the automated system .", "identifying hb below a threshold of @ g litre ( -@ ) for males had a high sensitivity ( @ % ) , while identifying a threshold of @ g litre ( -@ ) for females had lower sensitivity ( @ % ) .", "the specificity for males ( @ % ) and females ( @ % ) was similar .", "mean measurement bias and agreement : tolerability interval ratio was -@ g litre ( -@ ) and @ for men and -@ g litre ( -@ ) and @ for women .", "sphb was sensitive as a preliminary screening tool for detecting true low hb values in males , but less sensitive in females .", "instant sphb measurement may enable prompt routine preoperative anaemia management , but its precision was lower than expected .", "this study is approved by the tasmanian human ethics committee , australia and was registered prospectively in the australian and new zealand clinical trials registry ( http://www.anzctr.org.au/ actrn@ ) and the world health organization clinical trials registry ( http://apps.who.int/trialsearch/trial.aspx?trialid=actrn@ ) ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "hyperhomocysteinemia is a well-known risk factor for vascular disease .", "however , its action , mechanism , and role in the acute phase of stroke have not been determined .", "we tried to determine whether an association existed between elevated serum homocysteine levels and early neurological deterioration ( end ) in patients with acute ischemic stroke .", "we performed a secondary analysis from the cilostazol in acute ischemic stroke treatment ( caist ) trial , which was a double-blinded , randomized , multicenter trial , assessing the noninferiority of cilostazol over aspirin within @ hours of an acute ischemic stroke .", "end was defined as an increase of @ point in motor power or an increase of @ points in the total national institute of health stroke scale score within @ days .", "the mean ( sd ) serum homocysteine level was @ mol/l .", "of the @ patients studied , @ ( @ % ) patients worsened during the @ days after inclusion .", "most ( @ % ) of the end cases occurred within the first @ hours after treatment .", "high levels ( > @ mol/l ) of serum homocysteine were independent predictors for end ( third quartile odds ratio , @ ; @ % confidence intervals , @-@ @ ; p = @ ; fourth quartile odds ratio , @ ; @ % confidence intervals @-@ @ ; p = @ ) in multivariate analysis .", "patients with acute stroke with elevated serum homocysteine levels are at an increased risk for end ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "obesity amongst children is a growing problem worldwide .", "in contrast to adults , little is known on the effects of controlled weight loss on components of the metabolic syndrome in children .", "the primary aim of the study was to evaluate the effects of a @-week exercise and diet guidance intervention on body mass index ( bmi ) in a group of overweight children .", "our hypothesis was an observed reduction in bmi and secondarily in body fat content , insulin insensitivity , and other components of the metabolic syndrome in the intervention group .", "school children from copenhagen were randomly allocated to an intervention group ( n = @ ) or a control group ( n = @ ) .", "anthropometric assessment , whole body dual-energy x-ray absorptiometry scan , two hours oral glucose tolerance test , steps measured by pedometer , and fitness tests were measured at baseline and at @weeks .", "thirty-seven children ( @ girls ) participated at baseline , aged @ years with a bmi of @ kg/m@ ( meansd ) , and @ children completed the study .", "the intervention group decreased their bmi ( the intervention effect is the difference in change between the groups adjusted for the respective baseline values ( delta ) = -@ kg/m@ , @ % ci : -@ ; -@ , p < @ ) , total body mass ( delta = -@ kg , @ % ci : -@ ; -@ , p < @ ) , and fat mass ( delta = -@ kg , @ % ci : -@ ; -@ , p < @ ) compared to the control group after the intervention .", "the intervention group displayed decreased waist , hip and waist-to-height ratio ( whtr ) ( all three variables ; p < @ ) , area under curve for plasma insulin ( p < @ ) , and increased mean and minimum steps/day ( p < @ and p < @ , respectively ) .", "the multicomponent intervention had significant favorable effects on bmi , weight , whtr , mean and minimum steps/day , and fat mass .", "in addition , similar beneficial metabolic effects were found in the children as shown in adults , e.g. increase in peripheral insulin sensitivity .", "clinicaltrials.gov identifier number nct@ ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "hyperaminotransferasemia is an important problem in obese patients .", "we decide to examine the changes in hyperaminotransferasemia after weight reduction in obese patients with and without nafld secondary to a high monounsaturated fat vs. a high polyunsaturated fat hypocaloric diets .", "a population of @ obese patients was randomly allocated to two groups : diet m ( high monounsaturated fat hypocaloric diet ) and diet p ( high polyunsaturated fat hypocaloric diet ) .", "patients were classified as group i ( obese subjects ; n = @ ) when serum alt activity was normal or group ii ( nafld patients ; n = @ ) when serum alt activity was ( @ ui/l ) .", "in nafld group with diet m , bmi , weight , fat mass , waist circumference , systolic blood pressure , total cholesterol , ldl cholesterol ) , insulin and homa-r decreased .", "in nafld group with diet p , bmi , weight , fat mass , waist circumference , systolic blood pressure , total cholesterol , ldl cholesterol ) , insulin and homa-r decreased , too .", "in nafld group , alanine aminotransferase -lsb- ( diet m ) -@ ui/l vs. ( diet p ) -@ ui/l -rsb- , aspartate aminotransferase -lsb- ( diet m ) -@ ui/l vs. ( diet p ) -@ ui/l -rsb- , and gammaglutamyl transferase -lsb- ( diet m ) -@ ui/l vs. ( diet p ) -@ ui/l -rsb- improved with both diets .", "we showed that weight reduction secondary to two hypocaloric diets was associated with improvement in hypertransaminasemia and insulin resistance in nafld patients ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to assess whether customised mobile phone reminders would improve adherence to therapy and thus decrease virological failure among hiv infected patients starting antiretroviral treatment ( art ) .", "randomised controlled trial among hiv infected patients initiating antiretroviral treatment .", "three diverse healthcare delivery settings in south india : two ambulatory clinics within the indian national programme and one private hiv healthcare clinic .", "@ hiv infected , art nave , adult patients eligible to initiate first line art were randomly assigned to mobile phone intervention ( n = @ ) or standard care ( n = @ ) and followed for @ weeks .", "the intervention consisted of customised , interactive , automated voice reminders , and a pictorial message that were sent weekly to the patients ' mobile phones for the duration of the study .", "the primary outcome was time to virological failure ( viral load > @ copies/ml on two consecutive measurements ) .", "secondary outcomes included art adherence measured by pill count , death rate , and attrition rate .", "suboptimal adherence was defined as mean adherence < @ % .", "using an intention-to-treat approach we found no observed difference in time to virological failure between the allocation groups : failures in the intervention and standard care arms were @/@ ( @ % ) and @/@ ( @ % ) respectively ( unadjusted hazard ratio @ , @ % confidence interval @ to @ , p = @ ) .", "the rate of virological failure in the intervention and standard care groups were @ and @ per @ person years respectively .", "comparison of suboptimal adherence was similar between both groups ( unadjusted incidence rate ratio @ , @ % ci @ to @ , p = @ ) .", "incidence proportion of patients with suboptimal adherence was @/@ ( @ % ) in the intervention arm and @/@ ( @ % ) in the standard care arm .", "the results of analyses adjusted for potential confounders were similar , indicating no significant difference between the allocation groups .", "other secondary outcomes such as death and attrition rates , and subgroup analysis also showed comparable results across allocation groups .", "in this multicentre randomised controlled trial among art nave patients initiating first line art within the indian national programme , we found no significant effect of the mobile phone intervention on either time to virological failure or art adherence at the end of two years of therapy.trial registration current controlled trials isrctn@ ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to investigate the changes of b and t lymphocyte attenuator ( btla ) , reactive oxygen species ( ros ) , reactive nitrogen species ( rns ) , malondialdehyde ( mda ) , superoxide dismutase ( sod ) , catalase ( cat ) , total antioxidative capacity ( taoc ) in the patients with ankylosing spondylitis ( as ) and the effect of xinfeng capsule ( xfc ) on them .", "as patients ( n = @ ) were randomly divided into two groups , xfc group ( @ tablets each time , tid , n = @ ) and salicylazosulfapyridine ( sasp ) group ( @ pills each time , bid , n = @ ) .", "continuous treatment lasts @ months .", "the study also enrolled @ healthy volunteers as a control group .", "flow cytometry was used to test btla expression .", "elisa was performed to detect the oxidative stress indicators ( ros , rns , mda , sod , cat , taoc ) and cytokines ( il-@ , il-@ , il-@ , tnf - ) .", "western blotting was adopted to examine the blood sedimentation ( esr ) .", "hitachi @ automatic biochemical analyzer was used to determine the level of high sensitive c-reactive protein ( hs-crp ) .", "clinical efficacy of xfc group was significantly better than that of sasp group ( p < @ ) .", "compared with the healthy control group , as patients had significantly lower btla expression in cd@ ( + ) t cells and cd@ ( + ) t cells from the peripheral blood ( p < @ or p < @ ) , the decreased levels of sod , cat and taoc , and significantly increased ros , rns and mda values ( p < @ or p < @ ) .", "in addition , the levels of serum il-@ , tnf - , esr and hs-crp were significantly higher ( p < @ ) and il-@ , il-@ were significantly lower in as patients ( p < @ or p < @ ) .", "compared with pre-treatment , both xfc and sasp significantly elevated the expressions of btla ( + ) cd@ ( + ) t , btla ( + ) cd@ ( + ) t , btla , sod , taoc , il-@ , sf-@ ( pf , sf , rp , re , bp , mh , vt , gh ) eight dimension scores , and reduced ros , mda , tnf - , esr , hs-crp , vas , basdai , basfi and bas-g in the peripheral blood ( p < @ or p < @ ) .", "the differences between xfc group and sasp group were statistically significant ( p < @ or p < @ ) .", "pearson correlation analysis showed that btla expression level in the peripheral blood was positively correlated with sod , rp , bp , sf and re .", "btla ( + ) cd@ ( + ) t cells and btla * cd@ ( + ) t cells were significantly negatively correlated with ros , mda , il-@ , tnf - , esr , vas and basdai , and they were positively correlated with taoc , il-@ and il-@ .", "btla ( + ) cd@ ( + ) t cells were significantly negatively correlated with rns , hs-crp and basfi ; btla ( + ) cd@ ( + ) t cells were positively correlated with cat .", "xfc can improve btla expression in the peripheral blood of as patients and regulate negatively the activation and proliferation of t cells ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "hemolysis , occurring during cardiopulmonary bypass , is associated with lipid peroxidation and postoperative acute kidney injury .", "acetaminophen inhibits lipid peroxidation catalyzed by hemeproteins and in an animal model attenuated rhabdomyolysis-induced acute kidney injury .", "this pilot study tests the hypothesis that acetaminophen attenuates lipid peroxidation in children undergoing cardiopulmonary bypass .", "single-center prospective randomized double-blinded study .", "university-affiliated pediatric hospital .", "thirty children undergoing elective surgical correction of a congenital heart defect .", "patients were randomized to acetaminophen ( ofirmev -lsb- acetaminophen -rsb- injection ; cadence pharmaceuticals , san diego , ca ) or placebo every @ hours for four doses starting before the onset of cardiopulmonary bypass .", "markers of hemolysis , lipid peroxidation ( isofurans and f@-isoprostanes ) , and acute kidney injury were measured throughout the perioperative period .", "cardiopulmonary bypass was associated with a significant increase in free hemoglobin ( from a prebypass level of @ @ mg/dl to a peak of @ @ mg/dl postbypass ) .", "plasma and urine isofuran and f@-isoprostane concentrations increased significantly during surgery .", "the magnitude of increase in plasma isofurans was greater than the magnitude in increase in plasma f@-isoprostanes .", "acetaminophen attenuated the increase in plasma isofurans compared with placebo ( p = @ for effect of study drug ) .", "there was no significant effect of acetaminophen on plasma f@-isoprostanes or urinary makers of lipid peroxidation .", "acetaminophen did not affect postoperative creatinine , urinary neutrophil gelatinase-associated lipocalin , or prevalence of acute kidney injury .", "cardiopulmonary bypass in children is associated with hemolysis and lipid peroxidation .", "acetaminophen attenuated the increase in plasma isofuran concentrations .", "future studies are needed to establish whether other therapies that attenuate or prevent the effects of free hemoglobin result in more effective inhibition of lipid peroxidation in patients undergoing cardiopulmonary bypass ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "propofol , a short-acting hypnotic drug , is increasingly administered by a diverse group of specialists ( e.g. , cardiologists , gastroenterologists ) during diagnostic and therapeutic procedures .", "standard monitoring during sedation comprises continuous pulse oximetry with visual assessment of the patient 's breathing pattern .", "because undetected hypoventilation is a common pathway for complications , capnographic monitoring of exhaled carbon dioxide has been advocated .", "we examined whether the use of capnography reduces the incidence of hypoxemia during nonanesthesiologist-administered propofol sedation in patients who did not receive supplemental oxygen routinely .", "an open , stratified , randomized controlled trial was conducted in @ healthy adult women during minor gynecology procedures in an outpatient clinic in the netherlands .", "patients were randomly assigned to receive either standard respiratory monitoring ( standard care ) or standard respiratory monitoring combined with capnography ( capnography group ) .", "to replicate usual clinical practice , capnography monitoring was performed by the same medical team that provided sedation .", "the primary end point was the incidence of hypoxemia , defined as oxygen saturations < @ % .", "from april @ to january @ , @ patients were enrolled .", "in the capnography group , @ patients and in the standard care group , @ patients were analyzed .", "the percentage of patients with a hypoxemic episode was @ % ( @ of @ ) in the capnography group and @ % ( @ of @ ) in the standard care group , resulting in an absolute difference of @ % ( -@ to @ % ) .", "we were unable to confirm an additive role for capnography in preventing hypoxemia during elective nonanesthesiologist-administered propofol ( monotherapy ) sedation in healthy women in whom supplemental oxygen is not routinely administered .", "based on the confidence interval , the benefit of adding capnography is at most an absolute hypoxemia reduction of @ % , suggesting that adding it in this practice setting to the routine monitoring strategy does not necessarily improve patient safety in daily practice ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "long-term pharmacokinetics after supplementation with vitamin d@ or calcifediol ( the @-hydroxyvitamin d@ metabolite ) is not well studied .", "additionally , it is unclear whether bolus doses of vitamin d@ or calcifediol lead to @ ( oh ) d@ plasma concentrations considered desirable for fracture prevention ( @ ng/ml ) .", "we therefore investigated plasma pharmacokinetics of @ ( oh ) d@ during different vitamin d@ and calcifediol supplementation regimens .", "in this seven-arm , randomized , double-blind , controlled parallel-group study , @ healthy females aged @ years ( @ per group ) received @ g calcifediol or vitamin d ( @ ) daily , @ g calcifediol or vitamin d ( @ ) weekly , for @ weeks , or a single bolus of either @ g calcifediol , or vitamin d ( @ ) , or both .", "@ ( oh ) d@ plasma concentrations were quantified using lcms/ms in @ clinical visits among all participants .", "for daily ( weekly ) dosing , the area under the concentrationtime curve ( auc@h ) , which is the measure for exposure , was @ % ( @ % ) higher after the first dose of calcifediol than after the first dose of vitamin d@ .", "after @ weeks , this difference was @ % ( @ % ) .", "all women in the daily and weekly calcifediol groups achieved @ ( oh ) d@ concentrations > @ ng/ml ( mean , @ days ) , but only @ % in the vitamin d@ daily or weekly groups reached this concentration ( mean , @ days ) .", "a single dose of @ g calcifediol led to @ % higher @ ( oh ) d@ auc@h values than @ g vitamin d@ , while the simultaneous intake of both did not further increase exposure .", "calcifediol given daily , weekly , or as a single bolus is about @ times more potent in increasing plasma @ ( oh ) d@ concentrations than vitamin d@ .", "plasma @ ( oh ) d@ concentrations of @ ng/ml were reached more rapidly and reliably with calcifediol ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "many patients with severe asthma require regular treatment with oral glucocorticoids despite the use of high-dose inhaled therapy .", "however , the regular use of systemic glucocorticoids can result in serious and often irreversible adverse effects .", "mepolizumab , a humanized monoclonal antibody that binds to and inactivates interleukin-@ , has been shown to reduce asthma exacerbations in patients with severe eosinophilic asthma .", "in a randomized , double-blind trial involving @ patients with severe eosinophilic asthma , we compared the glucocorticoid-sparing effect of mepolizumab ( at a dose of @ mg ) with that of placebo administered subcutaneously every @ weeks for @ weeks .", "the primary outcome was the degree of reduction in the glucocorticoid dose ( @ to @ % reduction , @ to less than @ % reduction , @ to less than @ % reduction , more than @ to less than @ % reduction , or no decrease in oral glucocorticoid dose , a lack of asthma control during weeks @ to @ , or withdrawal from treatment ) .", "other outcomes included the rate of asthma exacerbations , asthma control , and safety .", "the likelihood of a reduction in the glucocorticoid-dose stratum was @ times greater in the mepolizumab group than in the placebo group ( @ % confidence interval , @ to @ ; p = @ ) .", "the median percentage reduction from baseline in the glucocorticoid dose was @ % in the mepolizumab group , as compared with no reduction in the placebo group ( p = @ ) .", "despite receiving a reduced glucocorticoid dose , patients in the mepolizumab group , as compared with those in the placebo group , had a relative reduction of @ % in the annualized rate of exacerbations ( @ vs. @ , p = @ ) and a reduction of @ points with respect to asthma symptoms ( p = @ ) , as measured on the asthma control questionnaire @ ( in which the minimal clinically important difference is @ points ) .", "the safety profile of mepolizumab was similar to that of placebo .", "in patients requiring daily oral glucocorticoid therapy to maintain asthma control , mepolizumab had a significant glucocorticoid-sparing effect , reduced exacerbations , and improved control of asthma symptoms .", "( funded by glaxosmithkline ; sirius clinicaltrials.gov number , nct@ . )" ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "longer duration of first-line chemotherapy for patients with metastatic breast cancer is associated with prolonged overall survival and improved progression-free survival .", "we investigated capecitabine added to maintenance bevacizumab after initial treatment with bevacizumab and docetaxel in this setting .", "we did this open-label randomised phase @ trial at @ hospitals in brazil , china , egypt , france , hong kong , india , italy , poland , spain , and turkey .", "we enrolled patients with her@-negative measurable metastatic breast cancer ; each received three to six cycles of first-line bevacizumab ( @ mg/kg ) and docetaxel ( @-@ mg/m ( @ ) ) every @ weeks .", "progression-free patients were randomly assigned with an interactive voice-response system by block ( size four ) randomisation ( @:@ ) to receive either bevacizumab and capecitabine or bevacizumab only ( bevacizumab @ mg/kg on day @ ; capecitabine @ mg/m ( @ ) twice per day on days @-@ , every @ weeks ) until progression , stratified by oestrogen receptor status ( positive vs negative ) , visceral metastases ( present vs absent ) , response status ( stable disease vs response vs non-measurable ) , and lactate dehydrogenase concentration ( @ vs > @upper limit of normal ) .", "neither patients nor investigators were masked to allocation .", "the primary endpoint was progression-free survival ( from randomisation ) in the intention-to-treat population .", "this trial is registered with clinicaltrials.gov , nct@ .", "between july @ , @ , and march @ , @ ( when enrolment was prematurely terminated ) , @ patients received initial bevacizumab and docetaxel ; @ ( @ % ) were randomly assigned ( @ to bevacizumab and capecitabine versus @ to bevacizumab only ) .", "progression-free survival was significantly longer in the bevacizumab and capecitabine group than in the bevacizumab only group ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; stratified hazard ratio @ -lsb- @ % ci @-@ -rsb- ; two-sided log-rank p < @ ) , as was overall survival ( median @ months -lsb- @ % ci @-not reached -rsb- vs @ months -lsb- @-@ -rsb- ; stratified hr @ -lsb- @ % ci @-@ -rsb- ; two-sided log-rank p = @ ) .", "results for time to progression were consistent with those for progression-free survival .", "@ ( @ % ) patients in the bevacizumab and capecitabine group and @ ( @ % ) in the bevacizumab only group had an objective response .", "clinical benefit was recorded in @ ( @ % ) patients in the bevacizumab alone group and @ ( @ % ) in the bevacizumab and capecitabine group .", "mean change from baseline in global health score did not differ significantly between groups .", "grade @ or worse adverse events during the maintenance phase were more common with bevacizumab and capecitabine than with bevacizumab only ( @ -lsb- @ % -rsb- of @ patients vs @ -lsb- @ % -rsb- of @ patients ) .", "the most common grade @ or worse events were hand-foot syndrome ( @ -lsb- @ % -rsb- in the bevacizumab and capecitabine group vs none in the bevacizumab alone group ) , hypertension ( eight -lsb- @ % -rsb- vs three -lsb- @ % -rsb- ) , and proteinuria ( three -lsb- @ % -rsb- vs four -lsb- @ % -rsb- ) .", "serious adverse events were reported by ten ( @ % ) patients in the bevacizumab and capecitabine group and seven ( @ % ) patients in the bevacizumab only group .", "despite prematurely terminated accrual and the lack of information about post-progression treatment , both progression-free survival and overall survival were significantly improved with bevacizumab and capecitabine compared with bevacizumab alone as maintenance treatment .", "these results might inform future maintenance trials and current first-line treatment strategies for her@-negative metastatic breast cancer .", "f hoffmann-la roche ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "facial exercises are a noninvasive alternative to medical approaches to facial rejuvenation .", "logopedists could be involved in providing these exercises .", "little research has been conducted , however , on the effectiveness of exercises for facial rejuvenation .", "this study assessed the effectiveness of @ exercises purportedly reducing wrinkles and sagging of the facial skin .", "a control group study was conducted with @ participants , @ of whom ( the experimental group ) underwent daily training for @ weeks .", "pictures taken before and after @ weeks of @ facial areas ( forehead , nasolabial folds , area above the upper lip , jawline and area under the chin ) were evaluated by a panel of laypersons .", "in addition , the participants of the experimental group evaluated their own pictures .", "evaluation included the pairwise presentation of pictures before and after @ weeks and scoring of the same pictures by means of visual analogue scales in a random presentation .", "only one significant difference was found between the control and experimental group .", "in the experimental group , the picture after therapy of the upper lip was more frequently chosen to be the younger-looking one by the panel .", "it can not be concluded that facial exercises are effective .", "more systematic research is needed ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "reactive oxygen species are markedly increased after ischemia and play important roles in the mechanism of ischemia-reperfusion injury .", "regulating the oxidative stress response after brain ischemia provides a potential therapeutic strategy .", "quercetin is a natural flavonoid that exhibits antioxidant properties .", "however , the mechanisms by which it protects cells are not fully understood .", "exercise training also reduces oxidative stress and enhances brain recovery .", "the purpose of this study was to determine whether combined exercise training with quercetin treatment could result in better neuroprotection and functional recovery in rats subjected to brain ischemia .", "rats were randomly assigned to the following groups : middle cerebral artery occlusion ( mcao ) with rest control , mcao with quercetin , mcao with exercise , or mcao with exercise and quercetin .", "to determine the effect of pi@k/akt pathway in quercetin and exercise-mediated neuroprotection , two additional groups , a group of mcao with quercetin and pi@k/akt inhibitor ( ly@ ) and a group of mcao with exercise , quercetin , and pi@k/akt inhibitor , were added in this study .", "motor function was examined at the @th hour and @th day post-mcao .", "brain samples were used to measure the expression of antioxidative and antiapoptotic proteins as well as to measure the infarct volume .", "treatment with either exercise or quercetin significantly decreased oxidative stress and infarct volume , increased antioxidative and antiapoptotic signaling , and improved motor function .", "exercise training combined with quercetin treatment resulted in better outcomes than either treatment alone .", "pi@k/akt inhibition eliminated the protective effects of exercise training and quercetin treatment .", "quercetin enhances exercise-mediated functional recovery after brain ischemia via up-regulation of pi@k/akt activity to promote antioxidative and antiapoptotic signaling ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "diclofenac dosing in children for analgesia is currently extrapolated from adult data .", "oral diclofenac @ mgkg ( -@ ) is recommended for children aged @-@years .", "analgesic effect from combination diclofenac/acetaminophen is unknown .", "children ( n = @ ) undergoing tonsillectomy ( c. @ ) were randomized to receive acetaminophen elixir @mgkg ( -@ ) before surgery and @mgkg ( -@ ) rectally at the end of surgery with diclofenac suspension @ mgkg ( -@ ) , @ mgkg ( -@ ) , or @ mgkg ( -@ ) before surgery or placebo .", "a further @ children were randomized to receive diclofenac @ mgkg ( -@ ) , @ mgkg ( -@ ) , or @ mgkg ( -@ ) only .", "postoperative pain was assessed ( visual analogue score , vas @-@ ) at half-hourly intervals from waking until discharge .", "data were pooled with those from a further @ children and @ adults .", "one-compartment models with first-order absorption and elimination described the pharmacokinetics of both medicines .", "combined drug effects were described using a modified emax model with an interaction term .", "an interval-censored model described the hazard of study dropout .", "analgesia onset had an equilibration half-time of @ h for acetaminophen and @ h for diclofenac .", "the maximum effect ( emax ) was @ .", "the concentration resulting in @ % of emax ( c@ ) was @ mgl ( -@ ) for diclofenac and @ mgl ( -@ ) for acetaminophen .", "a peak placebo effect of @ occurred at @h .", "drug effects were additive .", "the hazard of dropping out was related to pain ( hazard ratio of @ per unit change in pain ) .", "diclofenac @ mgkg ( -@ ) with acetaminophen @mgkg ( -@ ) achieves equivalent analgesia to acetaminophen @mgkg ( -@ ) .", "combination therapy can be used to achieve similar analgesia with lower doses of both drugs ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "the firis study previously demonstrated non-inferiority of iris ( irinotecan plus s-@ ) to folfiri ( @-fluorouracil/leucovorin with irinotecan ) for progression-free survival as the second-line chemotherapy for metastatic colorectal cancer ( mcrc ) as the primary endpoint .", "the overall survival ( os ) data were immature at the time of the primary analysis .", "between @ january @ and @ january @ , @ patients with mcrc who failed in first-line chemotherapy were randomly assigned to receive either folfiri or iris .", "after the primary analysis , the follow-up survey was cut off on @ july @ , and the final os data were analysed .", "with a median follow-up of @ months , the median os was @ months in the folfiri group and @ months in the iris group -lsb- hazard ratio ( hr ) @ ; @ % confidence interval ( ci ) @-@ @ -rsb- .", "in the pre-planned subgroup of patients who received prior chemotherapy containing oxaliplatin , the median os was @ months in the folfiri group and @ months in the iris group ( hr @ ; @ % ci @-@ @ ) .", "iris is non-inferior to folfiri for os as second-line chemotherapy for mcrc .", "iris can be an option for second-line chemotherapy of mcrc .", "( clinicaltrials.gov number : nct@ ) ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "hydrocodone/acetaminophen combination analgesics are frequently prescribed for chronic pain management ; however , acetaminophen presents potential hepatotoxicity to patients and thus dose limitations .", "these opioid medications are also widely abused .", "once-daily , single-entity hydrocodone ( hysingla er tablets -lsb- hyd -rsb- ) is a novel formulation with abuse-deterrent properties for the management of chronic pain and represents a suitable option for those patients receiving analgesics containing the same opioid analgesic , hydrocodone .", "this post-hoc analysis evaluated the efficacy and safety of hyd in patients whose primary pre-study analgesic was hydrocodone/acetaminophen analgesics ( @-@ % of the study populations ) .", "data were analyzed from two phase iii trials , a @-week randomized , placebo-controlled trial ( rct ) and an open-label , @-week trial .", "in both trials , a dose-titration period with hyd was followed by respective periods of fixed-dose double-blind ( randomized controlled trial -lsb- rct -rsb- ) or open-label , flexible-dose maintenance treatment .", "pain intensity was assessed using a numerical rating scale ( @-@ , @ = no pain ) .", "for the rct , primary and sensitivity analyses of pain scores used different approaches to handle missing data .", "safety data for both studies were summarized .", "in the rct , the mean baseline pain score was @ .", "pain relief was greater with hyd than placebo during double-blind treatment .", "in the open-label , flexible-dose trial , the majority of patients were maintained on their titrated dose .", "mean baseline pain score was @ , about @ % of patients completed the @-year maintenance period , and mean pain scores were between @ and @ during the maintenance period .", "use of supplemental pain medication decreased or was maintained during the maintenance treatment with hyd .", "adverse events in both trials were typical of those associated with opioid analgesics .", "in patients whose primary pretrial analgesic was hydrocodone/acetaminophen combination tablets , single-entity hyd was effective in reducing pain intensity and in maintaining analgesia over time without need for continued dose increase .", "hyd 's safety and tolerability profiles were similar to other opioid analgesics ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "stability between internal and external biological regulators are essential to stable mood states .", "however , the literature needs studies investigating the effect of brief psychotherapies in the biological rhythm regularization .", "to verify the capacity regulation of biological rhythms in two models of brief psychotherapy for the remission of depressive symptoms .", "we conducted a randomized clinical trial with young adults aged @-@ years old who met diagnostic criteria for depression according to the structured clinical interview for dsm ( scid ) .", "in order to evaluate the biological rhythm the biological rhythm of assessment in neuropsychiatry ( brian ) interview was used ; whereas the severity of depression was assessed by the hamilton depression rating scale ( hdrs ) .", "the psychotherapy models consisted of two cognitive psychotherapies : cognitive narrative therapy ( cnt ) and cognitive-behavioral therapy ( cbt ) .", "the sample consisted of @ randomized into two models of brief psychotherapy .", "the patients regulated the biological rhythm from baseline to post-intervention ( p = @ ) and follow up ( p = @ ) .", "we also found a positive moderate correlation between biological rhythm regularization and remission of the depressive symptoms ( r = @ ; p < @ ) .", "the two models of brief psychotherapies were effective in the remission of depressive symptoms as well as the regulation of biological rhythms in the follow-up of @ months .", "we did not assess genetic , hormonal and neurochemical factors .", "also , we did not include patients in pharmaceutical treatment , and with severe symptomatology ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases .", "systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk .", "we hypothesise that roux-en-y gastric bypass ( rygb ) surgery , a procedure that effectively reduces body weight , can also positively impact blood pressure control in obese and hypertensive individuals .", "a unicentric , randomised , controlled , unblinded clinical trial .", "sixty obese ( body mass index between @ and @ ) and moderately well controlled hypertensive patients , in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses , will be randomly allocated , using an online , electronic and concealed method , to receive either rygb plus optimised clinical treatment ( oct ) or oct alone .", "the primary end point is the reduction of antihypertensive medication at @ and @ years of follow-up .", "data analysis will primarily be conducted on an intention-to-treat basis .", "the study was approved by the local institutional review board that works in total compliance with the latest version of the helsinki declaration , the good clinical practices ( gcp ) , the ` america 's document ' and the national regulatory laws .", "before the beginning of any study-related activities , each study participant is asked to provide a signed informed consent .", "nct@ ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]

[ "we showed in a previous study that pylorus-resecting pancreaticoduodenectomy ( prpd ) , which divides the stomach adjacent to the pylorus ring , preserves more than @ % of the stomach and significantly reduced the incidence of delayed gastric emptying ( dge ) compared with pylorus-preserving pancreaticoduodenectomy ( pppd ) .", "however , long-term outcomes of prpd and the adverse effect of early postoperative dge on long-term outcomes remain unclear .", "a total of @ patients enrolled in a previous study were followed for @ months after surgery .", "primary endpoint was whether prpd is a better surgical procedure than pppd regarding long-term outcomes .", "weight loss > grade @ ( common terminology criteria for adverse events , version @ ) at @ months after surgery was significantly better in group prpd ( @ % ) than in group pppd ( @ % ) ( p = @ ) .", "nutritional status and late postoperative complications were similar for the two groups .", "the incidence of weight loss > grade @ at @ months was @ % in dge patients with dge and @ % in non-dge patients ( p = @ ) .", "t max ( time to peak ( @ ) co@ content in ( @ ) c-acetate breath test ) at @ months in dge patients was significantly delayed compared with that in non-dge patients ( @ @ vs. @ @ min , p = @ ) .", "serum albumin level at @ months was higher in non-dge patients than in those with dge ( @ @ vs. @ @ g/dl , p = @ ) .", "prpd offers long-term outcomes similar to those of pppd .", "dge may be associated with weight loss and poor nutritional status in patients with long-term outcomes ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "we previously developed a surface-controlled water-dispersible form of curcumin and named it theracurmin ( ) ( theracurmin ; theravalues , tokyo , japan ) .", "the area under the blood concentration-time curve of theracurmin in humans was @-fold higher than that of curcumin powder .", "we determined the clinical effects of orally administered theracurmin in patients with knee osteoarthritis during @ weeks of treatment .", "fifty patients with knee osteoarthritis of kellgren-lawrence grade ii or iii and who were aged more than @ years were enrolled in this randomized , double-blind , placebo-controlled , prospective clinical study .", "placebo or theracurmin containing @ mg/day of curcumin was administered orally every day for @ weeks .", "to monitor adverse events , blood biochemistry analyses were performed before and after @ weeks of each intervention .", "the patients ' knee symptoms were evaluated at @ , @ , @ , @ , and @ weeks by the japanese knee osteoarthritis measure , the knee pain visual analog scale ( vas ) , the knee scoring system of the japanese orthopedic association , and the need for nonsteroidal anti-inflammatory drugs .", "at @ weeks after treatment initiation , knee pain vas scores were significantly lower in the theracurmin group than in the placebo group , except in the patients with initial vas scores of @ or less .", "theracurmin lowered the celecoxib dependence significantly more than placebo .", "no major side effects were observed with theracurmin treatment .", "theracurmin shows modest potential for the treatment of human knee osteoarthritis ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "in recent years the video game industry has surpassed both the music and video industries in sales .", "currently violent video games are among the most popular video games played by consumers , most specifically first-person shooters ( fps ) .", "technological advancements in game play experience including the ability to play online has accounted for this increase in popularity .", "previous research , utilising the general aggression model ( gam ) , has identified that violent video games increase levels of aggression .", "little is known , however , as to the effect of playing a violent video game online .", "participants ( n = @ ) were randomly assigned to one of four experimental conditions ; neutral video game -- offline , neutral video game -- online , violent video game -- offline and violent video game -- online .", "following this they completed questionnaires to assess their attitudes towards the game and engaged in a chilli sauce paradigm to measure behavioural aggression .", "the results identified that participants who played a violent video game exhibited more aggression than those who played a neutral video game .", "furthermore , this main effect was not particularly pronounced when the game was played online .", "these findings suggest that both playing violent video games online and offline compared to playing neutral video games increases aggression ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "mindfulness based stress reduction ( mbsr ) is a secular form of meditation training .", "the vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons .", "previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention .", "we used a visual continuous performance task ( cpt ) to test the effects of eight weeks of mindfulness training on sustained attention by comparing mbsr to the health enhancement program ( hep ) , a structurally equivalent , active control condition in a randomized , longitudinal design ( clinicaltrials.gov , nct@ ) focusing on a non-clinical population typical of mbsr participants .", "researchers were blind to group assignment .", "@ community participants were randomized to either mbsr ( n = @ ) or hep ( n = @ ) .", "cpt analyses were conducted on @ mbsr participants and @ hep participants .", "we predicted that mbsr would improve visual discrimination ability and sustained attention over time on the cpt compared to hep , with more home practice associated with greater improvements .", "our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research .", "our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance .", "one of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable .", "attentional sensitivity is not affected by mindfulness practice as taught in mbsr , but it is unclear whether mindfulness might positively affect another aspect of attention , vigilance .", "these results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in similar samples .", "clinicaltrials.gov , nct@ ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "there is scarce and inconsistent information about gender-related differences in the hydration of sports persons , as well as about the effects of hydration on performance , especially during indoor sports .", "to determine the physiological differences between genders during in indoor physical exercise , with and without hydration .", "@ spinning sportspeople ( @ men and @ women ) participated in three controlled , randomly assigned and non-sequential hydration protocols , including no fluid intake and hydration with plain water or a sports drink ( volume adjusted to each individual every @ min ) , during @ min of spinning exercise .", "the response variables included body mass , body temperature , heart rate and blood pressure .", "during exercise without hydration , men and women lost ~ @ % of body mass , and showed higher body temperature ( ~ @ c ) , blood pressure ( ~ @ mmhg ) and heart rate ( ~ @ beats/min ) compared to exercises with hydration .", "body temperature and blood pressure were higher for men than for women during exercise without hydration , differences not observed during exercise with hydration .", "between @-@ % of variance in body temperature , blood pressure and heart rate could be explained by the physical characteristics of subjects and the work done .", "during exercise with hydration ( either with water or sport drink ) , the physiological response was similar for both genders .", "exercise without hydration produced physical stress , which could be prevented with either of the fluids ( plain water was sufficient ) .", "gender differences in the physiological response to spinning ( body temperature , mean blood pressure and heart rate ) can be explained in part by the distinct physical characteristics of each individual ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "higher serum urate concentrations predict more favorable prognosis in individuals with parkinson disease ( pd ) .", "the purpose of this study was to test the causality of this association using a mendelian randomization approach .", "the study was conducted among participants in datatop and precept , @ randomized trials among patients with early pd .", "the @ patients with available dna were genotyped for @ slc@a@ single nucleotide polymorphisms ( snps ) that identify an allele associated with lower urate concentrations , and for selected snps in other genes encoding urate transporters that have modest or no effect on serum urate levels .", "an slc@a@ score was created based on the total number of minor alleles at the @ slc@a@ loci .", "primary outcome was disability requiring dopaminergic treatment .", "serum urate concentrations were @ mg/dl lower among individuals with @ slc@a@ minor alleles as compared to those with @ ( p = @ ) .", "the hazard ratio ( hr ) for progression to disability requiring dopaminergic treatment increased with increasing slc@a@ score ( hr = @ , @ % confidence interval -lsb- ci -rsb- = @-@ @ , p = @ ) .", "in a comparative analysis , the hr was @ ( @ % ci = @-@ @ , p = @ ) for a @ mg/dl genetically conferred decrease in serum urate , and @ ( @ % ci = @-@ @ , p = @ ) for a @ mg/dl decrease in measured serum urate .", "no associations were found between polymorphisms in other genes associated with urate that do not affect serum urate and pd progression .", "this mendelian randomization analysis adds to the evidence of a causal protective effect of high urate levels ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to examine the relationship between perceived discrimination and medication adherence among black people with hypertension and the role of stress and depressive symptoms in this relationship .", "perceived racial discrimination has been associated with poor health outcomes in blacks ; its relationship to medication adherence among hypertensive patients remains untested .", "we measured perceived racial discrimination at baseline , stress and depressive symptoms at @ months , and medication adherence at @ months among patients enrolled in a @-site cluster-randomized controlled trial testing a patient and physician-targeted intervention to improve blood pressure .", "a mediational method with bootstrapping ( stratified by site ) confidence intervals was used to estimate the indirect association between perceived discrimination and medication adherence through stress and depression .", "of @ patients from @ sites enrolled in the trial , @ had complete data on all four measures at @ and @ months and were included in the analyses .", "adjusting for clustering , perceived discrimination was associated with poor medication adherence ( b = @ , p = @ ) at @ months , and with stress ( b = @ , p = @ ) and depression ( b = @ , p = @ ) at @ months .", "when stress and depression were included in the model , there was a @ % reduction in the total association of perceived discrimination with medication adherence , and the relationship was no longer significant ( b = @ , p = @ ) .", "perceived discrimination is associated with poor medication adherence among hypertensive blacks , and stress and depressive symptoms may account for this relationship .", "clinicaltrials.gov identifier : nct@ ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "the objective was to evaluate a configural vital signs ( cvs ) display designed to support rapid detection and identification of physiological deterioration by graphically presenting patient vital signs data .", "current display technology in the intensive care unit ( icu ) is not optimized for fast recognition and identification of physiological changes in patients .", "to support nurses more effectively , graphical or configural vital signs displays need to be developed and evaluated .", "a cvs display was developed based on findings from studies of the cognitive work of icu nurses during patient monitoring .", "a total of @ icu nurses interpreted data presented either in a traditional , numerical format ( n = @ ) or on the cvs display ( n = @ ) .", "response time and accuracy in clinical data interpretation ( i.e. , identification of patient status ) were assessed across four scenarios .", "data interpretation speed and accuracy improved significantly in the cvs display condition ; for example , in one scenario nurses required only half of the time for data interpretation and showed up to @ times higher accuracy in identifying the patient state compared to the numerical display condition .", "providing patient information in a configural display with readily visible trends and data variability can improve the speed and accuracy of data interpretation by icu nurses .", "although many studies , including this one , support the use of configural displays , the vast majority of icu monitoring displays still present clinical data in numerical format .", "the introduction of configural displays in clinical monitoring has potential to improve patient safety ." ]

[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "this study aims to observe the impact of the temperature of blood transfusion and infusion toward the perioperative cerebral oxygen metabolism and the postoperative cognitive recovery .", "eighty patients of knee replacement under epidural and general anesthesia were randomly divided into warming blood transfusion and infusion ( wbi ) group ( n = @ ) and control group ( n = @ ) .", "the changes of nasopharyngeal temperature , middle cerebral artery blood flow , cero , and sjvo of the two groups were recorded at each time point for the assessment of the postoperative overall quality of recovery and cognitive recovery situation .", "the nasopharyngeal temperatures of the two groups at different time points after transfusion were significantly lower than that at t@ , and there was a significant difference between the two groups ( p < @ ) .", "the cero values of the two groups at t@ were significantly higher than at t@ , while the sjvo values were significantly decreased ( p < @ ) .", "the wbi can significantly reduce the occurrence of the perioperative hypothermia , while it has no significant effect toward cerebral oxygen metabolism , postoperative overall recovery , and recovery of cognitive function ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to assess the effect of a screening tool of older persons potentially inappropriate prescriptions/screening tool to alert doctors to right treatment ( stopp/start ) medication intervention on clinical and economic outcomes .", "parallel-group randomized trial .", "chronic care geriatric facility .", "residents aged @ and older prescribed with at least one medication ( n = @ ) were randomized to receive usual pharmaceutical care or undergo medication intervention .", "screening medications with stopp/start criteria followed up with recommendations to the chief physician .", "the outcome measures assessed at the initiation of the intervention and @year later were number of hospitalizations and falls , functional independence measure ( fim ) , quality of life ( measured using the medical outcomes study @-item short-form health survey ) , and costs of medications .", "the average number of drugs prescribed was significantly lower in the intervention than in the control group after @year ( p < @ ) .", "the average drug costs in the intervention group decreased by @ shekels ( us$ @ ) per participant per month ( p < @ ) .", "the average number of falls in the intervention group dropped significantly ( p = @ ) .", "rates of hospitalization , fim scores , and quality of life measurements were similar for both groups .", "implementation of stopp/start criteria reduced the number of medications , falls , and costs in a geriatric facility .", "their incorporation in those and similar settings is recommended ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the combination melphalan-prednisone-thalidomide ( mpt ) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation .", "however , emerging data on the use of lenalidomide and low-dose dexamethasone warrant a prospective comparison of the two approaches .", "we randomly assigned @ patients to lenalidomide and dexamethasone in @-day cycles until disease progression ( @ patients ) , to the same combination for @ weeks ( @ cycles ; @ patients ) , or to mpt for @ weeks ( @ patients ) .", "the primary end point was progression-free survival with continuous lenalidomide-dexamethasone versus mpt .", "the median progression-free survival was @ months with continuous lenalidomide-dexamethasone , @ months with @ cycles of lenalidomide-dexamethasone , and @ months with mpt ( hazard ratio for the risk of progression or death , @ for continuous lenalidomide-dexamethasone vs. mpt and @ for continuous lenalidomide-dexamethasone vs. @ cycles of lenalidomide-dexamethasone ; p < @ for both comparisons ) .", "continuous lenalidomide-dexamethasone was superior to mpt for all secondary efficacy end points , including overall survival ( at the interim analysis ) .", "overall survival at @ years was @ % with continuous lenalidomide-dexamethasone , @ % with @ cycles of lenalidomide-dexamethasone , and @ % with mpt .", "grade @ or @ adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with mpt ( @ % vs. @ % ) .", "as compared with mpt , continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events , a moderate increase in infections , and fewer second primary hematologic cancers .", "as compared with mpt , continuous lenalidomide-dexamethasone given until disease progression was associated with a significant improvement in progression-free survival , with an overall survival benefit at the interim analysis , among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation .", "( funded by intergroupe , francophone du mylome and celgene ; first clinicaltrials.gov number , nct@ ; european union drug regulating authorities clinical trials number , @-@-@ . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "to determine the effect of implementation of the integrated management of neonatal and childhood illness strategy on treatment seeking practices and on neonatal and infant morbidity .", "cluster randomised trial .", "haryana , india .", "@,@ births in nine intervention clusters and @,@ births in nine control clusters .", "the pre-specified outcome was the effect on treatment seeking practices .", "post hoc exploratory analyses assessed morbidity , hospital admission , post-neonatal infant care , and nutritional status outcomes .", "the integrated management of neonatal and childhood illness intervention included home visits by community health workers , improved case management of sick children , and strengthening of health systems .", "outcomes were ascertained through interviews with randomly selected caregivers : @ , @ , and @ in intervention clusters and @ , @ , and @ in control clusters at ages @ days , @ months , and @ months , respectively .", "in the intervention cluster , treatment was sought more often from an appropriate provider for severe neonatal illness ( risk ratio @ , @ % confidence interval @ to @ ) , for local neonatal infection ( @ , @ to @ ) , and for diarrhoea at @ months ( @ , @ to @ ) and @ months ( @ , @ to @ ) and pneumonia at @ months ( @ , @ to @ ) and @ months ( @ , @ to @ ) .", "intervention mothers reported fewer episodes of severe neonatal illness ( risk ratio @ , @ to @ ) and lower prevalence of diarrhoea ( @ , @ to @ ) and pneumonia ( @ , @ to @ ) in the two weeks preceding the @ month interview and of diarrhoea ( @ , @ to @ ) and pneumonia ( @ , @ to @ ) in the two weeks preceding the @ month interview .", "infants in the intervention clusters were more likely to still be exclusively breast fed in the sixth month of life ( risk ratio @ , @ to @ ) .", "implementation of the integrated management of neonatal and childhood illness programme was associated with timely treatment seeking from appropriate providers and reduced morbidity , a likely explanation for the reduction in mortality observed following implementation of the programme in this study.trial registration clinical trials nct@ ; icmr clinical trial registry ctri/@/@ / @ ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "we have already reported that , for patients undergoing elective colon cancer operations , perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented .", "synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations .", "the effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial .", "three hundred ten patients with colon cancer randomly were assigned to one of three groups .", "all patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation .", "probiotics were administered in group a ; oral antibiotics were administered in group b ; and neither probiotics nor oral antibiotics were administered in group c. stool samples were collected @ and @ days before and @ and @ days after the procedure .", "clostridium difficile toxin and the number of bacteria in the intestine were determined .", "the rates of incisional surgical-site infection were @ % , @ % , and @ % in groups a , b , and c , and the rates of leakage were @ % , @ % , and @ % in groups a , b , and c , respectively , indicating that both rates were lesser in group b than in groups a and c ( p = @ and p = @ , respectively ) .", "the detection rates of c. difficile toxin were not changed among the three groups .", "we recommend oral antibiotics , rather than probiotics , as bowel preparation for elective colon cancer procedures to prevent surgical-site infections ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "orthodontic appliances can promote accumulation of dental plaque , with associated enamel decalcification or gingival inflammation .", "the aim of this study was to examine longer-term microbiological changes during orthodontic treatment with fixed appliances .", "twenty-four orthodontic patients aged @-@ years undergoing fixed appliance therapy were recruited into the study .", "each was randomized for cross-mouth assignment of molar bands and bonded molar tubes to contralateral quadrants of the mouth .", "all patients received self-ligating brackets , but again using randomization , one upper lateral incisor bracket ( left or right ) also received an elastomeric ligature .", "plaque samples from the molars and upper lateral incisors were obtained at intervals during treatment and up to @ year after appliance removal .", "denaturing gradient gel electrophoresis and @s rdna microarray were used to compare plaque microbial fingerprints .", "plaque populations changed within @ months of commencing treatment at all sites .", "the greatest differences in plaque composition were seen with self-ligating brackets with an elastomeric ligature .", "post-treatment plaque associated with both types of molar attachment contained increased levels of periodontal pathogens porphyromonas gingivalis , tannerella forsythia , and eubacterium nodatum , while campylobacter rectus , parvimonas micra , and actinomyces odontolyticus were also elevated with bonds .", "the results suggest that orthodontic treatment may cause sustained changes in plaque microbiotas and that molar bond-associated plaque may have raised disease potential ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "oral corticosteroids were used to control stable chronic obstructive pulmonary disease ( copd ) decades ago .", "however , recent guidelines do not recommend long-term oral corticosteroids ( ltoc ) use for stable copd patients , partly because it causes side-effects such as respiratory muscle deterioration and immunosuppression .", "nonetheless , the impact of ltoc on life prognosis for stable copd patients has not been clarified .", "we used the data of patients randomized to non-surgery treatment in the national emphysema treatment trial .", "severe and very severe stable copd patients who were eligible for volume reduction surgery were recruited at @ clinical centers in the united states and randomized during @-@ .", "patients were followed-up for at least five years .", "hazard ratios for death by ltoc were estimated by three models using cox proportional hazard analysis and propensity score matching .", "the pre-matching cohort comprised @ patients ( prescription of ltoc : @ % .", "age : @ year old .", "female : @ % .", "percent predicted forced expiratory volume in one second : @ % .", "mortality during follow-up : @ % ) .", "hazard ratio using a multiple-variable cox model in the pre-matching cohort was @ ( p = @ ) .", "propensity score matching was conducted with @ parameters ( c-statics : @ ) .", "the propensity-matched cohort comprised of @ ltoc ( + ) cases and @ ltoc ( - ) cases ( prescription of ltoc : @ % .", "age : @ year old .", "female : @ % .", "percent predicted forced expiratory volume in one second : @ % .", "mortality during follow-up : @ % ) .", "no parameters differed between cohorts .", "the hazard ratio using a single-variable cox model in the propensity-score-matched cohort was @ ( p = @ ) .", "the hazard ratio using a multiple-variable cox model in the propensity-score-matched cohort was @ ( p = @ ) .", "ltoc may increase the mortality of stable severe and very severe copd patients ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "induction methods for therapeutic cooling are under investigated .", "we compared the effectiveness and safety of cold infusions ( ci ) and nasopharyngeal cooling ( npc ) for cooling induction in stroke patients .", "a prospective , open-label , randomised ( @:@ ) , single-centre pilot trial with partially blinded safety endpoint assessment was conducted at the neurointensive care unit of heidelberg university .", "intubated stroke patients with an indication for therapeutic cooling and an intracranial pressure ( icp ) / temperature brain probe were randomly assigned to ci ( @c , @l at @l/h ) or npc ( @l/min for @ h ) .", "previous data suggested a maximum decrease of tympanic temperature for ci ( @ l within @ min ) after @ min .", "therefore the study period was @ hour ( @ min subperiods i-iv ) .", "the brain temperature course was the primary endpoint .", "secondary measures included continuous monitoring of neurovital parameters and extracerebral temperatures .", "statistical analysis based on repeated-measures analysis of variance .", "of @ patients screened , @ were randomized within @ months .", "infusion time of @l ci was @ min in @ patients and @ patients received npc for @ min .", "during active treatment ( first @ min ) , brain temperature decreased faster with ci than during npc ( i : -@ @ versus -@ @ c , p = @ ; ii : -@ @ versus -@ @ c , p = @ ) .", "in the ci-group , after the infusion was finished , the intervention no longer decreased brain temperature , which increased after @ min .", "oesophageal temperature correlated best with brain temperature during ci and npc .", "tympanic temperature reacted similarly to relative changes of brain temperature during ci , but absolute values slightly differed .", "ci provoked three severe adverse events during subperiods ii-iv ( two systolic arterial pressure ( sap ) , one shivering ) compared with four in the npc-group , all during subperiod i ( three sap , one icp ) .", "classified as possibly intervention-related , two cases of ventilator failure occurred during npc .", "in intubated stroke patients , brain cooling is faster during ci than during npc .", "importantly , contrary to previous expectations , brain cooling stopped soon after ci cessation .", "oesophageal but neither bladder nor rectal temperature is suited as surrogate for brain temperature during ci and npc .", "several severe adverse events in ci and in npc demand further studying of safety .", "clinicaltrials.gov nct@ .", "registered @ march @ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "despite widespread popularity , text messaging has rarely been used for data collection in clinical research .", "this paper reports on the development , feasibility , acceptability , validity , and discriminant utility of a single item depression rating scale , delivered weekly via an automated sms system , as part of a large randomised controlled trial .", "@ depressed patients ( bdi-ii score @ ) were recruited from primary care into a randomised trial of acupuncture versus counselling or usual care , and invited to opt into a repeated-measures text messaging sub-study .", "two weeks following random allocation , trial participants were sent a weekly text message for @ weeks .", "texts were a single question asking , on a scale from @ to @ , the extent to which they felt depressed .", "feasibility and acceptability of the automated sms system were evaluated according to cost , ease of implementation , proportion consenting , response rates , and qualitative feedback .", "concurrent validity was estimated by correlating sms responses with the patient health questionnaire ( phq-@ ) .", "sms responses were compared between groups over time to explore treatment effects .", "@ ( @ % ) trial participants consented to the texting sub-study , of whom @ ( @ % ) responded to at least one message .", "participants provided a valid response to an average of @ messages .", "invalid responses accounted for @ % of texts .", "the automated sms system was quick to set-up , inexpensive , and well received .", "comparison of phq-@ and sms responses at @ months demonstrated a moderate to high degree of agreement ( kendall 's tau-b = @ , p < @ , n = @ ) .", "sms depression scores over the @ weeks differed significantly between trial arms ( p = @ ) , with participants allocated to the acupuncture and counselling arms reporting improved depression outcomes compared to usual gp care alone , which reached statistical significance ten weeks after randomisation .", "overall , the single item sms scale also appeared more responsive to changes in depression , resulting from treatment , than the phq-@ .", "automated sms systems offer a feasible and acceptable means of monitoring depression within clinical research .", "this study provides clear evidence to support the regular use of a simple sms scale as a sensitive and valid outcome measure of depression within future randomised controlled trials .", "current controlled trials - isrctn@ http://www.controlled-trials.com/isrctn@/acudep date of registration : @/@/@ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "to explore the effectiveness and safety of transcutaneous electrical acupoint stimulation ( teas ) combined with infusion of propofol in anodynia bronchoscopy .", "ninety patients who received selective bronchoscopy were randomized into a group of compound teas with infusion of propofol ( group a ) , a group of compound fentanyl with propofol ( group b ) and a group of simple propofol ( group c ) .", "in group a , the plaster electrode stimulation was applied at bilateral hegu ( li @ ) , laogong ( pc @ ) , neiguan ( pc @ ) and waiguan ( te @ ) .", "the anesthesia was induced after @ min of stimulation till the end of examination .", "in group b and group c , the electric stimulation was not adopted .", "in group b , before anesthesia , fentanyl @ microg/kg was injected intravenously .", "afterwards , the intravenous infusion of propofol was used in the the three groups for anesthesia .", "the mean arterial pressure ( map ) , heart rate ( hr ) , saturation of pulse oximetry ( spo@ ) and respiratory rate ( rr ) were recorded at different time points .", "the induced dosage and total dosage of propofol , examination time , the awakening time and adverse reactions were observed in the patients of each group .", "the difference in examination time was not significant among the three groups ( p > @ ) .", "the postoperative awakening time in group a was earlier than that in group b and group c -lsb- ( @ + / - @ ) s vs ( @ + / - @ ) s , ( @ + / - @ ) s , both p < @ -rsb- .", "the total dosage of propofol in group c was larger than those in group a and group b -lsb- ( @ + / - @ ) mg vs ( @ + / - @ ) mg , ( @ + / - @ ) mg , both p < @ -rsb- .", "the induced dosage in group c was larger than those in group a and group b -lsb- ( @ + / - @ ) mg vs ( @ + / - @ ) mg , ( @ + / - @ ) mg , both p < @ -rsb- .", "every life physical sign in group a during examination was more stable as compared with that in group b and group c.", "the incidence of hypotension and bradycardia in group a were lower than those in group c -lsb- @ % ( @/@ ) vs @ % ( @/@ ) , @ % ( @/@ ) vs @ % ( @/@ ) , both p < @ -rsb- .", "the adverse incidence of oxygen supply in group a was lower than that in group b -lsb- @ % ( @/@ ) vs @ % ( @/@ ) , p < @ -rsb- .", "intraoperative awareness and improper memory did not happen in postoperative investigation .", "in the transcutaneous electrical acupoint stimulation combined with infusion of propofol in anodynia bronchoscopy , the physical sign of patient is stable with less adverse reactions .", "this method reduces anesthetic dosage and shortens the postoperative awakening time , which can be effectively applied in bronchoscopy ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the purpose of this study was to assess the association between positive post-radiation therapy ( rt ) biopsy results and subsequent clinical outcomes in males with localized prostate cancer .", "radiation therapy oncology group study @-@ analyzed @ males with prostate cancer , stage t@b-t@b and prostate-specific antigen concentrations of @ ng/dl , to investigate whether @ months of total androgen suppression ( tas ) added to rt improved survival compared to rt alone .", "patients randomized to receive tas received flutamide with luteinizing hormone releasing hormone ( lhrh ) agonist .", "according to protocol , patients without evidence of clinical recurrence or initiation of additional endocrine therapy underwent repeat prostate biopsy @ years after rt completion .", "statistical analysis was performed to evaluate the impact of positive post-rt biopsy results on clinical outcomes .", "a total of @ patients underwent post-rt biopsy , @ were treated with rt alone and @ with rt plus tas .", "patients with positive post-rt biopsy results had higher rates of biochemical failure ( hazard ratio -lsb- hr -rsb- = @ ; @ % confidence interval -lsb- ci -rsb- = @-@ @ ) and distant metastasis ( hr = @ ; @ % ci = @-@ @ ) and inferior disease-specific survival ( hr = @ ; @ % ci = @-@ @ ) .", "positive biopsy results remained predictive of such outcomes after correction for potential confounders such as gleason score , tumor stage , and tas administration .", "prior tas therapy did not prevent elevated risk of adverse outcome in the setting of post-rt positive biopsy results .", "patients with gleason score @ with a positive biopsy result additionally had inferior overall survival compared to those with a negative biopsy result ( hr = @ ; @ % ci = @-@ @ ) .", "positive post-rt biopsy is associated with increased rates of distant metastases and inferior disease-specific survival in patients treated with definitive rt and was associated with inferior overall survival in patients with high-grade tumors ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to compare the extent of bleeding and patient discomfort during packing removal of three different polyvinyl alcohol ( pva ) packs : @ ) a standard pva sponge ( s-pva ) ( mondocel standard @ cm ; mondomed nv , hamont-achel , belgium ) ; @ ) a pva sponge with oxidized cellulose ( oc-pva ) ( merocel hemox @ cm ; medtronic xomed surgical products , jacksonville , fl ) ; and @ ) a pva sponge with polyethylene film ( pf-pva ) ( merocel @ @ cm ; medtronic xomed surgical products , jacksonville , fl ) , after functional endoscopic sinus surgery and inferior turbinoplasty .", "a prospective , randomized , blinded , controlled trial .", "ninety consecutive patients were enrolled and randomized to receive in each side one pack in the middle meatus and another pack of the same material in the nasal fossa .", "the patients were equally divided in three groups of @ patients each .", "group a received the pf-pva ; group b received oc-pva ; and group c received s-pva .", "postoperatively , bleeding after removal of the entire nasal packing was evaluated by an observer , whereas the severity of pain was rated by patients with visual analog scales .", "our study evaluated three nasal packing materials , demonstrating that the pf-pva is less painful than the others but with intermediate bleeding ratio .", "however , the oc-pva has an intermediate pain score but minimum bleeding .", "the s-pva showed the worst pain and bleeding results .", "considering that removal of the second pack ( middle meatus ) is more painful than the first ( nasal fossa ) , our results suggest that a pf-pva can be placed in the middle meatus and a oc-pva in the nasal fossa in order to reduce patient 's discomfort in terms of pain and bleeding .", "@b ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]

[ "to compare patency and overall survival achieved with covered versus uncovered metallic stents among patients with inoperable malignant extrahepatic biliary obstruction .", "there were @ patients enrolled in this prospective randomized study between january @ and july @ .", "mean age of patients was @ years ( range , @-@ y ) .", "the malignancies causing extrahepatic biliary obstruction were pancreatic cancer ( n = @ ) , stomach cancer ( n = @ ) , gallbladder cancer ( n = @ ) , common bile duct cancer ( n = @ ) , and other cancer types ( n = @ ) .", "uncovered ( n = @ ) and covered ( n = @ ) stents were used .", "stent patency , overall survival , and complications were evaluated and statistically compared .", "mean patency of uncovered stents ( @ d @ ) was significantly longer than mean patency of covered ones ( @ d @ ; p = @ ) .", "mean overall survival was @ days @ for uncovered stents , which was statistically similar to survival of @ days @ for covered stents ( p = @ ) .", "causes of recurrent obstruction included tumor ingrowth ( n = @ ) , tumor overgrowth ( n = @ ) , debris or food material ( n = @ ) , and stent migration ( n = @ ) .", "one case of acute cholecystitis occurred in covered stent group .", "uncovered metallic stents had superior patency duration than covered stents for patients with malignant extrahepatic biliary obstruction .", "however , the overall complication and survival rates achieved with covered and uncovered stents were similar ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "to evaluate the clinical and microbiological effects of neodymium : yttrium-aluminum-garnet laser therapy as an adjunct to scaling and root planing during the hygienic phase .", "in eight patients , sites with a mean probing pocket depth ( ppd ) of @ mm were treated by either scaling and root planing ( n = @ ) ( control ) or by scaling and root planing and adjunctive laser therapy ( n = @ ) ( power : @w ) .", "re-evaluation was at @-@ weeks .", "thereafter , remaining pockets ( mean ppd @ mm ) were eliminated by either laser surgery ( power : @ w ) or gingivectomy ( control ) .", "at baseline , the mean ppd of sites originally presenting with a mean ppd @ mm were @ and @ mm in the test and control sites , respectively .", "six months following surgery , there was a similar average mean ppd reduction in the test ( @ mm , p < @ ) and control sites ( @ mm , p < @ ) .", "also , the reduction in bleeding on probing in both groups was statistically significant ( p < @ , paired t-tests ) .", "no statistically-significant differences between the test and control sites were found for any clinical or microbiological parameters at baseline , after initial , and @ or @ months ' post-surgical therapy .", "during the hygienic phase , neodymium : yttrium-aluminum-garnet ( @ nm ) laser treatment yielded no superiority in clinical efficacy compared to conventional debridement .", "laser gingivectomy resulted in similar treatment outcomes ( mean ppd and bleeding on probing reduction ) , as did conventional gingivectomy ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "a pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program .", "a randomized , single-blind cross-over design .", "ten ambulant children with bilateral spastic cerebral palsy , age four to nine years .", "participants were randomly assigned into a ten-week individually defined , targeted or a general program , followed by a cross-over .", "evaluation was performed using the gross motor function measure-@ and three-dimensional gait analysis .", "general outcome parameters were gross motor function measure-@ scores , time and distance parameters , gait profile score and movement analysis profiles .", "individual goal achievement was evaluated using z-scores for gait parameters and goal attainment scale for gross motor function .", "no significant changes were observed regarding gross motor function .", "only after individualized therapy , step - and stride-length increased significantly ( p = @ ; p = @ ) .", "change in step-length was higher after the individualized program ( p = @ ) .", "within-group effects were found for the pelvis in transversal plane after the individualized program ( p = @ ) and in coronal plane after the general program ( p = @ ) .", "between-program differences were found for changes in the knee in sagittal plane , in the advantage of the individual program ( p = @ ) .", "a median difference in z-score of @ and @ was measured after the general and individualized program , respectively .", "functional goal attainment was higher after the individual therapy program compared with the general program ( @ to @ ) .", "the results indicate slightly favorable effects towards the individualized program .", "to detect clinically significant changes , future studies require a minimal sample size of @ to @ participants ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "mental illness stigma is a serious societal problem and a critical impediment to treatment seeking for mentally ill people .", "to improve the understanding of mental illness stigma , this study focuses on the simultaneous analysis of people 's aetiological beliefs , attitudes ( i.e. perceived dangerousness and social distance ) , and recommended treatments related to several mental disorders by devising an over-arching latent structure that could explain the relations among these variables .", "three hundred and sixty university students randomly received an unlabelled vignette depicting one of six mental disorders to be evaluated on the four variables on a likert-type scale .", "a one-factor latent class analysis ( lca ) model was hypothesized , which comprised the four manifest variables as indicators and the mental disorder as external variable .", "the main findings were the following : ( a ) a one-factor lca model was retrieved ; ( b ) alcohol and drug addictions are the most strongly stigmatized ; ( c ) a realistic opinion about the causes and treatment of schizophrenia , anxiety , bulimia , and depression was associated to lower prejudicial attitudes and social rejection .", "beyond the general appraisal of mental illness an individual might have , the results generally point to the acknowledgement of the specific features of different diagnostic categories .", "the implications of the present results are discussed in the framework of a better understanding of mental illness stigma ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "we examined data from a phase @ trial -lcb- nct@ -rcb- of ivacaftor , a cftr potentiator , in cystic fibrosis ( cf ) patients with ag@d mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference ( npd ) to estimate cftr activity .", "sweat chloride and npd were secondary endpoints in this placebo-controlled , multicenter trial .", "standardization of sweat collection , processing , and analysis was employed for the first time .", "sweat chloride and chloride ion transport ( npd ) were integrated into a model of cftr activity .", "within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects .", "analysis of changes in sweat chloride and npd demonstrated that patients treated with ivacaftor achieved cftr activity equivalent to approximately @ % @ % of normal .", "sweat chloride is useful in multicenter trials as a biomarker of cftr activity and to test the effect of cftr potentiators ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "this study aims to determine whether vitamin d levels are associated with menopause-related symptoms in older women .", "a randomly selected subset of @,@ women , among @,@ potentially eligible participants of the women 's health initiative calcium and vitamin d trial of postmenopausal women aged @ to @ years , had @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- levels measured at the women 's health initiative calcium and vitamin d trial baseline visit .", "information about menopause-related symptoms at baseline was obtained by questionnaire and included overall number of symptoms and composite measures of sleep disturbance , emotional well-being , and energy/fatigue , as well as individual symptoms .", "after exclusions for missing data , @ women ( mean -lsb- sd -rsb- age , @ -lsb- @ -rsb- y ) were included in these analyses .", "borderline significant associations between @ ( oh ) d levels and total number of menopausal symptoms were observed ( with p values ranging from @ to @ for fully adjusted models ) ; however , the effect was clinically insignificant and disappeared with correction for multiple testing .", "no associations between @ ( oh ) d levels and composite measures of sleep disturbance , emotional well-being , or energy/fatigue were observed ( p 's > @ for fully adjusted models ) .", "there is no evidence for a clinically important association between serum @ ( oh ) d levels and menopause-related symptoms in postmenopausal women ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "hypothermia in patients undergoing major clean surgery results in higher incidence of perioperative complications .", "the aim of this study was to evaluate whether the additional use of a thermal reflective blanket can prevent hypothermia in patients undergoing primary unilateral total hip or knee replacement surgery .", "a randomized , single-blinded study design was used .", "a total of @ patients were randomized , @ received a thermal reflective blanket , and @ did not .", "outcome measures included core temperature , thermal comfort , and shivering .", "the mean of the lowest core temperature was below @c in both the groups ( @ c vs @ c ) ; thermal comfort and shivering were not significantly different between the groups .", "a thermal reflective blanket did not prevent hypothermia in this group of patients ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "labelling of food from fast food restaurants at point-of-purchase has been suggested as one strategy to reduce population energy consumption and contribute to reductions in obesity prevalence .", "the aim of this study was to examine the effects of energy and single traffic light labelling systems on the energy content of child and adult intended food purchases .", "the study employed a randomised controlled trial design .", "english speaking parents of children aged between three and @ years were recruited from an existing research cohort .", "participants were mailed one of three hypothetical fast food menus .", "menus differed in their labelling technique either energy labels , single traffic light labels , or a no-label control .", "participants then completed a telephone survey which assessed intended food purchases for both adult and child .", "the primary trial outcome was total energy of intended food purchase .", "a total of @ participants completed the follow-up telephone interview .", "eighty-two percent of the energy labelling group and @ % of the single traffic light labelling group reported noticing labelling information on their menu .", "there were no significant differences in total energy of intended purchases of parents , or intended purchases made by parents for children , between the menu labelling groups , or between menu labelling groups by socio-demographic subgroups .", "this study provided no evidence to suggest that energy labelling or single traffic light labelling alone were effective in reducing the energy of fast food items selected from hypothetical fast food menus for purchase .", "additional complementary public health initiatives promoting the consumption of healthier foods identified by labelling , and which target other key drivers of menu item selection in this setting may be required ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the local anaesthetics used in day-case spinal anaesthesia should provide short recovery times .", "we aimed to compare hyperbaric prilocaine and bupivacaine in terms of sensory block resolution and time to home readiness in day-case spinal anaesthesia .", "methods : fifty patients undergoing perianal surgery were randomized into two groups .", "the bupivacaine-fentanyl group ( group b ) received @ mg , @ % hyperbaric bupivacaine + @ g fentanyl in total @ ml .", "the prilocaine-fentanyl group ( group p ) received @ mg , @ % hyperbaric prilocaine + @ g fentanyl in the same volume .", "time to l@ block and maximum block was shorter in group p than in group b ( group p @ @ min versus group b @ @ min , p = @ , and group p @ @ min versus group b @ @ min , p = @ ) .", "the time to l@ regression and s@ regression of the sensorial block was significantly shorter in group p than in group b ( @ @ min versus @ @ min , p = @ , and @ @ min versus @ @ min , p < @ ) .", "the mean time to home readiness was shorter for group p than for group b ( @ @ min versus @ @ min ( p < @ ) ) .", "day-case spinal anaesthesia with hyperbaric prilocaine + fentanyl is superior to hyperbaric bupivacaine in terms of earlier sensory block resolution and home readiness and the surgical conditions are comparable for perianal surgery ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "the present randomized study was designed to compare the efficacy between two active vitamin d analogs , alfacalcidol ( acd ) and maxacalcitol ( oct ) , for the management of mild secondary hyperparathyroidism ( shpt ) in dialysis patients .", "shpt in all @ patients analyzed in the study was initially treated with oct. .", "once patients ' intact pth levels decreased to the target range of @ - @ pg/ml , they were randomized either to switch to acd at @ g/day ( n = @ ) , or to remain on an effectively unchanged dose of oct ( n = @ ) .", "phosphate , calcium , and intact pth levels were measured every @ weeks for @ weeks and vitamin d doses were changed according to target ranges of phosphate ( @ - @ mg/dl ) , calcium ( albuminadjusted calcium : @ - @ mg/dl ) , and intact parathyroid hormone ( @ - @ pg/ml ) .", "achievement rates of the target ranges of the parameters were estimated .", "baseline calcium levels in the oct group were significantly higher than in the acd group .", "changes in achievement rates of target ranges of intact pth and calcium during the study did not differ significantly between the vitamin d drugs .", "changes in calcium levels in the oct and acd groups were similar during the study .", "achievement rates of the target range of phosphate in both groups were also similar until @ weeks , although the rate in the oct group declined at @ weeks .", "the efficacy and safety of oct for the treatment of mild shpt are similar to those of acd in hemodialysis patients ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "trimetazidine has been shown to improve angina pectoris and left ventricular ( lv ) function in diabetic patients with ischaemic cardiomyopathy .", "the objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and lv structure after drug-eluting stent ( des ) implantation in elderly multivessel coronary heart disease ( chd ) patients with diabetes mellitus ( dm ) and a left ventricular ejection fraction ( lvef ) of @ % .", "this was a single-centre , prospective , randomized , double-blind evaluation study .", "between january @ and september @ , @ chd patients with dm who were aged @ years and undergoing coronary angiography at an zhen hospital ( beijing , china ) were recruited and prospectively randomized to receive trimetazidine ( @ mg three times daily ) or placebo after des implantation as an addition to conventional chd treatment .", "the primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters , which included lvef .", "at @-year follow-up , patients in the trimetazidine group ( n = @ ) showed significant improvements in the incidence ( p = @ ) and severity of angina pectoris , compared with the control group , as well as silent myocardial ischaemia ( p = @ ) and angina pectoris-free survival ( p = @ ) .", "lv function and structure in trimetazidine-treated patients were relatively stable at @-year follow-up , while they deteriorated in the control group ( n = @ ) with a significant difference between groups ( all p < @ ) .", "the e peak to a peak ( e/a ) ratio in trimetazidine-treated patients and in the control group decreased after @ years ; the e/a ratio in trimetazidine-treated patients was slightly better than that in the control group , without a significant difference ( p = @ ) .", "there was no significant difference in event-free survival for the composite end point including death , myocardial infarction , cerebrovascular accident ( p = @ ) and subsequent revascularization ( p = @ ) .", "adjunctive therapy with trimetazidine after des implantation can have a beneficial effect on recurrent angina pectoris as well as lv function and structure in elderly multivessel chd patients with dm ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to study the factors affecting long-term treatment results of displaced intraarticular calcaneal fractures ( diacfs ) .", "a post hoc analysis .", "tertiary care teaching hospitals .", "eight to twelve years of results from a randomized controlled multicenter trial of operative versus nonoperative treatment ( n = @ ) were divided into @ groups : the superior @ % results ( n = @ ) and the inferior @ % results ( n = @ ) , regardless of the treatment given .", "the determinant of this division was a visual analog score for pain and function .", "the operative treatment consists of open reduction and internal fixation , whereas the nonoperative treatment consists of nonweight bearing and early range of motion exercise .", "a visual analog score for pain and function , the short-form @ ( sf-@ ) general health outcome questionnaire , the american orthopaedic foot & ankle society ( aofas ) hindfoot scale , and olerud-molander score .", "we compared age , sex , fracture type ( sanders classification ) , treatment given , bhler angle , residual articular surface step-off at healing , type of occupation , and injury insurance between the @ groups .", "patients of the superior group had higher physical sf-@ , aofas , and olerud-molander score than in the inferior group .", "operative treatment , better bhler angle and articular surface restoration , light labor/retirement , and absence of injury insurance were more common in the superior group .", "age , sex , pretreatment bhler angle , and fracture type were comparable in the superior and inferior groups .", "the decision making for definitive treatment of intraarticular calcaneal fractures is multifactorial with a spectrum of results and trends such as patient demographic features that should be considered in choosing the best treatment option .", "prognostic level ii .", "see instructions for authors for a complete description of levels of evidence ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS", "METHODS" ]

[ "this phase ii study examined the efficacy of mapatumumab in combination with paclitaxel and carboplatin in patients with non-small-cell lung cancer ( nsclc ) .", "patients with stage iiib or stage iv advanced primary nsclc were randomly assigned ( @:@:@ ) to receive up to @ courses of standard-dose paclitaxel and carboplatin or a combination of paclitaxel , carboplatin , and mapatumumab ( @ mg/kg or @ mg/kg ) .", "primary efficacy end points were overall response rate and median progression-free survival ( pfs ) .", "secondary efficacy end points included disease control rate , overall survival ( os ) , time to response , and duration of response .", "exploratory studies included evaluation of historical biopsy materials for trail-r@ expression by immunohistochemical analysis and serum levels of m@ , a marker of apoptosis , before and after the first @ doses of mapatumumab .", "safety parameters , including adverse events ( aes ) , laboratory tests , and immunogenicity , were assessed .", "the majority of patients had stage iv disease ( @ % ) and an eastern cooperative oncology group ( ecog ) performance status of @ ( @ % ) ; baseline characteristics were similar across treatment arms .", "no improvements in response or disease control rates , pfs , or os were gained from the addition of mapatumumab .", "adverse events in the mapatumumab arms were generally consistent with toxicities seen in the carboplatin and paclitaxel control arm .", "levels of m@ were highly variable , and consistent patterns were not seen across treatment arms .", "this study showed no clinical benefit from adding mapatumumab to carboplatin and paclitaxel in unselected patients with nsclc .", "the combination was generally well tolerated .", "the possibility of subgroups sensitive to mapatumumab is discussed ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "in the context of a group randomized field trial , we evaluated whether parents who participated in a workplace intervention , designed to increase supervisor support for personal and family life and schedule control , reported significantly more daily time with their children at the @-month follow-up compared with parents assigned to the usual practice group .", "we also tested whether the intervention effect was moderated by parent gender , child gender , or child age .", "the support-transform-achieve-results intervention was delivered in an information technology division of a us fortune @ company .", "participants included @ parents ( @ % mothers ) of a randomly selected focal child aged @ to @ years ( @ % daughters ) who completed daily telephone diaries at baseline and @ months after intervention .", "during evening telephone calls on @ consecutive days , parents reported how much time they spent with their child that day .", "parents in the intervention group exhibited a significant increase in parent-child shared time , @ minutes per day on average , between baseline and the @-month follow-up .", "by contrast , parents in the usual practice group averaged @ fewer minutes with their child per day at the @-month follow-up .", "intervention effects were evident for mothers but not for fathers and for daughters but not sons .", "the hypothesis that the intervention would improve parents ' daily time with their children was supported .", "future studies should examine how redesigning work can change the quality of parent-child interactions and activities known to be important for youth health and development ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "otolaryngology residents need concise , easily accessible modules to expand educational opportunities between surgical cases .", "these modules should be inexpensive to create and improve learning outcomes .", "the purpose of this pilot study was to assess whether otolaryngology residents at multiple institutions used online video modules to supplement their studying for the otolaryngology training exam , whether the modules had any effect on their otolaryngology training examination scores , and to obtain survey feedback about the modules .", "this randomized trial was conducted in @ academic departments of otolaryngology in the united states among @ residents enrolled in @ otolaryngology residency programs .", "residents were randomized into @ groups , one with access to the educational modules and the other with no access .", "otolaryngology training examination scores were obtained from the year prior to the intervention ( @ ) and the year following module access ( @ ) .", "residents with access to the modules were also surveyed to assess use and obtain feedback about the modules .", "otolaryngology training examination scores improved significantly from @ to @ among both residents who had access to the modules and those who did not in the sections of head and neck , laryngology , and sleep medicine .", "however , scores in the sections of pediatric otolaryngology ( @ % increase , p = @ ) , otology ( @ % increase , p = @ ) , and facial plastic surgery ( @ % increase , p = @ ) improved from @ to @ only among residents with access to the modules .", "all respondents rated the videos as very helpful , with a rating of @ of @ on a likert scale .", "online otolaryngology educational modules are an inexpensive way to expand resident learning opportunities .", "despite the lack of quantifiable improvement in otolaryngology training examination scores in this study , use of online modules sends a message to otolaryngology residents that their education is a priority ; self-study outside the hospital and clinics is necessary and expected ; and that instructors are willing to try more nontraditional or progressive forms of education to increase resident knowledge ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the aim of the present prospective , randomized , controlled , clinical study was to compare the outcomes of periradicular surgery of the maxillary first molar tooth using the vestibular approach between @ preoperative radiologic evaluation methods : cone beam computed tomography ( cbct ) and conventional radiography .", "periradicular surgery was applied to the maxillary first molar tooth in @ patients .", "the patients were divided into @ groups .", "the patients in group @ underwent examination and preoperative planning with cbct , and the patients in group @ underwent examination and preoperative planning with conventional radiography .", "the outcomes of the treatment were evaluated radiographically and clinically , and the data were analyzed statistically .", "the mean operative time was significantly shorter in group @ than in group @ .", "according to the radiographic and clinical healing criteria used in the present study , the healing of patients in group @ was rated as a success in @ % , an improvement in @ % , and a failure in @ % .", "in the group @ patients , healing was rated as a success in @ % , an improvement in @ % , and a failure in @ % .", "sinus membrane elevation was performed in @ % of all patients .", "sinus membrane perforation occurred in @ % of the patients in group @ and @ % of the patients in group @ .", "periradicular surgery of maxillary first molars using a vestibular approach is a viable treatment method with a low complication rate .", "preoperative cbct examination demonstrated positive contributions to the treatment outcomes ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "to evaluate safety and visual outcomes after proton beam irradiation ( pbi ) therapy for subfoveal choroidal neovascularisation ( cnv ) secondary to causes other than age-related macular degeneration ( amd ) .", "this study is a prospective , unmasked and randomised clinical trial using two dosage regimens , conducted in the massachusetts eye and ear infirmary .", "the study included @ patients with cnv secondary to non-amd and best-corrected visual acuity of @/@ or better .", "patients were randomly assigned to receive @ or @ cobalt gray equivalents ( cge ) of pbi in two equal fractions .", "complete ophthalmological examinations , fundus photography and fluorescein angiography were performed at baseline and @ , @ , @ and @months after treatment .", "at @year after treatment , @ % and @ % lost fewer than @ lines of vision in the @ cge and in @ cge groups , respectively .", "at @years after therapy , @ % in the lower dose group and @ % in the higher dose group lost fewer than @ lines of vision .", "mild radiation complications such as radiation vasculopathy developed in @ % of patients .", "pbi is a safe and efficacious treatment for subfoveal cnv not due to amd .", "the data with respect to visual outcomes and radiation complications trend in favour of the @ cge group , although differences do not reach statistical significance .", "pbi may be considered as an alternative to current therapies ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "recently , rimabotulinumtoxinb has been increasingly used as an off-label treatment of primary axillary hyperhidrosis ( pah ) .", "however , the optimal conversion ratios for onabotulinumtoxina and rimabotulinumtoxinb remain to be determined .", "to compare effectiveness , satisfaction level , and safety of rimabotulinumtoxinb with onabotulinumtoxina at a conversion ratio of @:@ for the treatment of pah .", "adults with pah were enrolled in this bilaterally paired single-subject study .", "each patient was randomly treated with @,@ u rimabotulinumtoxinb on @ axilla and @ u onabotulinumtoxina contralaterally .", "hyperhidrosis disease severity scale was assessed before and after treatment up to @ weeks .", "a @-cm visual analog scale representing improvement of hidrotic symptom and starch-iodine test were also used to assess therapeutic efficacy .", "twenty-four patients completed the study .", "both groups showed comparable and efficacious anhidrotic effects through @ weeks for any variable .", "there were no significant differences in terms of the onset of action or mean duration of action between the @ groups .", "overall satisfaction with the treatment was equally high in both groups .", "both toxins showed comparable anhidrotic effect for the treatment of axillary hyperhidrosis at a conversion ratio of @:@ ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "video capsule endoscopy ( vce ) is recommended as the first exploration in obscure digestive bleeding .", "the efficiency of the pillcam sb@ ( given imaging ) has been widely reported .", "the capsocam capsule ( capsovision ) has four cameras allowing the exploration of the small bowel through @ lateral viewing .", "this system does not include a recording system so the capsule has to be retrieved by the patient after expulsion in order for the film to be downloaded .", "the aim of this study was to evaluate diagnostic concordance ( kappa value ) of the pillcam sb@ and capsocam capsules in the same patients .", "this was a prospective comparative study in four french referral endoscopy units .", "consecutive patients ingested the two capsules @ hour apart and in a randomized order .", "in the @ included patients there were @ technical issues ( @ capsocam , @ pillcam sb@ ) .", "of the @ patients with analyzable data , and following expert review of all discordant cases , a concordant positive diagnosis was obtained in @ ( @ % ) and a negative diagnosis was obtained and @ patients ( @ % ) .", "concordance was good , with a kappa value of @ in analyzable patients , and @ % diagnosis with capsocam vs. @ % with pillcam sb@.capsocam and pillcam sb@ procedures identified @ % ( @/@ ) and @ % ( @/@ ) of positive patients , respectively ( p = @ ) .", "in a per lesion analysis , the capsocam capsule detected significantly more lesions ( @ vs. @ lesions ; p = @ ) .", "reading time was longer for capsocam procedures ( @ vs. @ minutes ; p = @ ) .", "this study shows comparable efficiency of the capsocam and pillcam sb@ capsule systems in terms of diagnostic yield and image quality ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "the impact of omega-@ polyunsaturated fatty acids ( pufas ) for prevention of atrial fibrillation ( af ) is still part of a lively debate .", "the present study evaluates the impact of orally administered omega-@ ethyl ester concentrate ( omega-@ pufa ) on postoperative onset of af in patients with recent myocardial infarction ( @ months ) undergoing isolated coronary artery bypass grafting ( cabg ) .", "patients and", "the study included a total of @ patients with recent ( @ months ) myocardial infarction .", "the treatment group consisted of @ prospectively and randomly assigned patients .", "a matched control group was generated out of the entirety of patients undergoing isolated cabg during the same time period , being not treated with omega-@ pufa .", "primary endpoint was onset of postoperative af .", "patients of the treatment group received a daily dose of @g omega-@ pufa , initiated @ days before surgery .", "effective serum levels were confirmed by laboratory testing .", "patients of the treatment group had less frequently postoperative af ( treatment : @ % vs. control : @ % ; p = @ ) .", "the reduction in relative risk was @ % in the treatment group , which conforms a number needed to treat ( nnt ) of @ patients .", "a more pronounced effect with a nnt of @ was observed in patients@ years ( p = @ ) .", "besides , patients of the treatment group had a shorter intensive care unit stay ( p = @ ) and suffered less frequently from impaired wound healing by trend ( p = @ ) .", "one patient out of treatment group and two out of control group died during hospital stay ( p = @ ) .", "preoperative administration of @g omega-@ pufa reduces incidence of postoperative af in patients with recent ( @ months ) myocardial infarction undergoing isolated cabg ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "magnesium enhances the effect of rocuronium .", "sugammadex reverses rocuronium-induced neuromuscular block .", "the authors investigated whether magnesium decreased the efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular block .", "thirty-two male patients were randomized in a double-blinded manner to receive magnesium sulfate ( mgso@ ) @ mg/kg or placebo intravenously before induction of anesthesia with propofol , sufentanil , and rocuronium @ mg/kg .", "neuromuscular transmission was monitored using tof-watch sx acceleromyography ( organon ltd. , dublin , ireland ) .", "in @ patients , sugammadex @ mg/kg was administered intravenously at reappearance of the second twitch of the train-of-four ( moderate block ) .", "in @ further patients , sugammadex @ mg/kg was administered intravenously at posttetanic count @ to @ ( deep block ) .", "primary endpoint was recovery time from injection of sugammadex to normalized train-of-four ratio @ .", "secondary endpoint was recovery time to final t@ .", "average time for reversal of moderate block was @ min ( sd , @ ) in patients pretreated with mgso@ and @ min ( @ ) in those pretreated with placebo ( p = @ ) .", "average time for reversal of deep block was @ min ( @ ) in patients pretreated with mgso@ and @ min ( @ ) in those pretreated with placebo ( p = @ ) .", "times to final t@ were longer compared with times to normalized train-of-four ratio @ , without any difference between patients pretreated with mgso@ or placebo .", "pretreatment with a single intravenous dose of mgso@ @ mg/kg does not decrease the efficacy of recommended doses of sugammadex for the reversal of a moderate and deep neuromuscular block induced by an intubation dose of rocuronium ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "systemic glucocorticoids reduce the incidence of bronchopulmonary dysplasia among extremely preterm infants , but they may compromise brain development .", "the effects of inhaled glucocorticoids on outcomes in these infants are unclear .", "we randomly assigned @ infants ( gestational age , @ weeks @ days to @ weeks @ days ) to early ( within @ hours after birth ) inhaled budesonide or placebo until they no longer required oxygen and positive-pressure support or until they reached a postmenstrual age of @ weeks @ days .", "the primary outcome was death or bronchopulmonary dysplasia , confirmed by means of standardized oxygen-saturation monitoring , at a postmenstrual age of @ weeks .", "a total of @ of @ infants assigned to budesonide for whom adequate data were available ( @ % ) , as compared with @ of @ infants assigned to placebo for whom adequate data were available ( @ % ) , died or had bronchopulmonary dysplasia ( relative risk , stratified according to gestational age , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) .", "the incidence of bronchopulmonary dysplasia was @ % in the budesonide group versus @ % in the placebo group ( relative risk , stratified according to gestational age , @ ; @ % ci , @ to @ ; p = @ ) ; death occurred in @ % and @ % of the patients , respectively ( relative risk , stratified according to gestational age , @ ; @ % ci , @ to @ ; p = @ ) .", "the proportion of infants who required surgical closure of a patent ductus arteriosus was lower in the budesonide group than in the placebo group ( relative risk , stratified according to gestational age , @ ; @ % ci , @ to @ ; p = @ ) , as was the proportion of infants who required reintubation ( relative risk , stratified according to gestational age , @ ; @ % ci , @ to @ ; p = @ ) .", "rates of other neonatal illnesses and adverse events were similar in the two groups .", "among extremely preterm infants , the incidence of bronchopulmonary dysplasia was lower among those who received early inhaled budesonide than among those who received placebo , but the advantage may have been gained at the expense of increased mortality .", "( funded by the european union and chiesi farmaceutici ; clinicaltrials.gov number , nct@ . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "to observe the impact of xinkeshu on top of standard medication on psychological stress-related emotional and biophysiological parameters in patients with mental stress-induced myocardial ischemia ( msimi ) .", "a randomized controlled clinical trial was conducted on @ patients with msimi and patients were randomized into treatment group ( n = @ ) and control group ( n = @ ) by random number table method .", "patients in the treatment group received xinkeshu ( @ capsules/d ) on top of standard therapy , and the control group received placebo on top of standard therapy .", "serum homocysteine ( hcy ) , patient health questionnaire-@ ( phq-@ ) , generalized anxiety disorder-@ ( gad-@ ) , left ventricular ejection fraction ( lvef ) and left ventricular fractional shortening ( lvfs ) were compared between the groups at baseline and after @ weeks therapy .", "( @ ) baseline data were similar between the @ groups ( all p > @ ) .", "( @ ) after @ weeks , lvfs was significantly increased ( from ( @ @ ) % to ( @ @ ) % , p = @ ) and serum hcy ( from ( @ @ ) mol/l to ( @ @ ) mol/l ) , phq-@ ( from @ @ to @ @ ) and gad-@ ( from @ @ to @ @ ) were significantly reduced in treatment group ( all p < @ ) compared to baseline .", "in the control group , only gad-@ was significantly reduced ( from @ @ to @ @ , p = @ ) after @ weeks therapy compared to baseline ( p < @ ) while other parameters remained unchanged ( all p > @ ) .", "xinkeshu on the top of standard therapy can improve the emotional state and left ventricular systolic function in patients with msimi ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "to study the effect of protocolized measurement ( three times daily ) of the modified early warning score ( mews ) versus measurement on indication on the degree of implementation of the rapid response system ( rrs ) .", "a quasi-experimental study was conducted in a university hospital in amsterdam between september and november @ .", "patients who were admitted for at least one overnight stay were included .", "wards were randomized to measure the mews three times daily ( `` protocolized '' ) versus measuring the mews `` when clinically indicated '' in the control group .", "at the end of each month , for an entire seven-day week , all vital signs recorded for patients were registered .", "the outcomes were categorized into process measures including the degree of implementation and compliance to set monitoring standards and secondly , outcomes such as the degree of delay in physician notification and rapid response team ( rrt ) activation in patients with raised mews ( mews@ ) .", "mews calculations from vital signs occurred in @ % ( @/@ ) on the protocolized wards versus @ % ( @/@ ) in the control group .", "compliance with the protocolized regime was presents in @ % ( @/@ ) , compliance in the control group was present in @ % ( @/@ ) of the measurements .", "there were @ calls to primary physicians on the protocolized and @ calls on the control wards .", "additionally on protocolized wards , there were twice as much rrt calls per admission .", "vital signs and mews determination three times daily , results in better detection of physiological abnormalities and more reliable activations of the rrt ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "influenza virus infection-induced inflammatory responses are associated with fever and other symptoms .", "although macrolide antibiotics ( macrolides ) provide anti-inflammatory effects , these effects have not been well studied in influenza patients .", "we examined the effects of clarithromycin on influenza symptoms .", "a randomized , prospective , and open-label study was performed between december @ and march @ and between december @ and march @ in patients with pandemic a/h@ @ influenza or seasonal influenza virus infections .", "patients aged > @ years received either neuraminidase inhibitors ( control group ) or clarithromycin plus neuraminidase inhibitors ( clarithromycin group ) .", "body temperature and other symptoms were recorded for @ days after initiating treatment .", "serum interleukin ( il ) -@ and il-@ levels were also measured .", "herein , @ patients were enrolled over the two influenza seasons , and data from @ patients were analyzed .", "all patients showed fever and other symptoms , including rhinorrhea ( n = @ ) , cough ( n = @ ) , sore throat ( n = @ ) , arthralgia or myalgia ( n = @ ) , and general malaise ( n = @ ) .", "fever duration was approximately @ % shorter in patients with temperatures @ c ( p = @ ) , decreasing from @ h to @ h. among patients with pandemic influenza infections ( n = @ ) , the rhinorrhea improvement rate was higher in the clarithromycin group ( p = @ ; @ % vs. @ % ) .", "serum il-@ levels decreased @ days after treatment , but no differences between the two groups were detected .", "clarithromycin may have the additional clinical benefit of improving fever , the main symptom of influenza , in patients treated with neuraminidase inhibitors ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "community-based participatory research ( cbpr ) approaches that involve community and academic partners in activities ranging from protocol design through dissemination of study findings can increase recruitment of medically underserved and underrepresented racial/ethnic minority populations into biomedical research .", "five cancer screening and prevention trials in three national cancer institute ( bethesda , md ) - funded community networks program centers ( cnpc ) , in florida , kansas , and south carolina , were conducted across diverse populations .", "data were collected on total time period of recruitment , ratios of participants enrolled over potential participants approached , selected cbpr strategies , capacity-building development , and systematic procedures for community stakeholder involvement .", "community-engaged approaches used included establishing colearning opportunities , participatory procedures for community-academic involvement , and community and clinical capacity building .", "a relatively large proportion of individuals identified for recruitment was actually approached ( between @ % and @ % ) .", "the proportion of subjects who were eligible among all those approached ranged from @ % to more than @ % ( in the community setting ) .", "recruitment rates were very high ( @ % -@ % of eligible individuals approached ) and the proportion who refused or who were not interested among those approached was very low ( @ % -@ % ) .", "recruitment strategies used by the cnpcs were associated with low refusal and high enrollment ratios of potential subjects .", "adherence to cbpr principles in the spectrum of research activities , from strategic planning to project implementation , has significant potential to increase involvement in biomedical research and improve our ability to make appropriate recommendations for cancer prevention and control programming in underrepresented diverse populations .", "cbpr strategies should be more widely implemented to enhance study recruitment ." ]

[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "affecting mother and child , malaria during pregnancy ( mip ) provokes a double morbidity and mortality burden .", "within a package of interventions to prevent mip in endemic areas , the who currently recommends intermittent preventive treatment ( iptp ) .", "concerns about anti-malarial resistance have however prompted interest in intermittent screening and treating ( ist ) as an alternative approach to iptp .", "ist involves screening for malaria infection at scheduled antenatal care ( anc ) clinic visits and treating malaria cases .", "in light of the need to comprehensively evaluate new interventions prior to roll out , this article explores the acceptability of ist with artemether-lumefantrine ( al ) compared to iptp with sulphadoxine-pyrimethamine ( sp ) and in upper east region , northern ghana .", "data were collected alongside an open-label , randomized , controlled trial of ist-al and iptp-sp in kassena-nankana district .", "thirty pregnant women enrolled in the clinical trial participated in six focus group discussions .", "ten in-depth interviews were carried out with clinical trial staff .", "observations were also made at the health facilities where the clinical trial took place .", "trial participants were generally willing to endure the discomfort of the finger prick necessary for a rapid diagnostic test for malaria and this reflected a wider demand for diagnostic techniques .", "reports of side effects were however linked to both trial anti-malarials .", "direct complaints about sp were particularly severe with regard to women 's experience of vomiting .", "although the follow-up treatment doses of al for ist were not supervised , based on blister inspection and questioning trial , staff were confident about participants ' adherence to the treatment course .", "one case of partial adherence to the al treatment course was reported .", "despite the discomfort of the finger prick required to perform the intermittent malaria screening , trial participants generally expressed more positive sentiments towards ist-al than iptp-sp .", "nonetheless , questions remain about adherence to a multiple dose anti-malarial regimen during pregnancy , particularly in endemic areas where mip is often non-symptomatic .", "any implementation of ist must be accompanied by appropriate health messages on adherence and the necessary training for health staff regarding case management ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "the treatment of patients with varicose veins constitutes a considerable workload and financial burden to the national health service .", "this study aimed to assess the cost-effectiveness of ultrasound-guided foam sclerotherapy ( ugfs ) and endovenous laser ablation ( evla ) compared with conventional surgery as treatment for primary varicose veins .", "participant cost and utility data were collected alongside the uk class multicentre randomized clinical trial , which compared evla , surgery and ugfs .", "regression methods were used to estimate the effects of the alternative treatments on costs to the health service and quality-adjusted life-years ( qalys ) at @ months .", "a markov model , incorporating available evidence on clinical recurrence rates , was developed to extrapolate the trial data over a @-year time horizon .", "compared with surgery at @ months , ugfs and evla reduced mean costs to the health service by @ and @ respectively .", "when additional overhead costs associated with theatre use were included , these cost savings increased to @ and @ respectively .", "ugfs produced @ fewer qalys , whereas evla produced @ additional qalys .", "extrapolating to @ years , evla was associated with increased costs and qalys compared with ugfs ( costing @ per qaly gained ) , and generated a cost saving ( @-@ ) and qaly gain ( @ ) compared with surgery .", "applying a ceiling willingness-to-pay ratio of @ @ per qaly gained , evla had the highest probability ( @ per cent ) of being cost-effective .", "the results suggest , for patients considered eligible for all three treatment options , that evla has the highest probability of being cost-effective at accepted thresholds of willingness to pay per qaly ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "this study investigated whether self-reports of alcohol-related postings on facebook by oneself or one 's facebook friends were related to common motives for drinking and were uniquely predictive of self-reported alcohol outcomes ( alcohol consumption , problems , and cravings ) .", "pacific northwest undergraduates completed a survey of alcohol outcomes , drinking motives , and alcohol-related facebook postings .", "participants completed the survey online as part of a larger study on alcohol use and cognitive associations .", "participants were randomly selected through the university registrar 's office and consisted of @,@ undergraduates ( @ men , @ women , @ transgender , @ declined to answer ) between the ages of @ and @ years ( m = @ , sd = @ ) at a large university in the pacific northwest .", "seven participants were excluded from analyses because of missing or suspect data .", "alcohol-related postings on facebook were significantly correlated with social , enhancement , conformity , and coping motives for drinking ( all ps < @ ) .", "after drinking motives were controlled for , self-alcohol-related postings independently and positively predicted the number of drinks per week , alcohol-related problems , risk of alcohol use disorders , and alcohol cravings ( all ps < @ ) .", "in contrast , friends ' alcohol-related postings only predicted the risk of alcohol use disorders ( p < @ ) and marginally predicted alcohol-related problems ( p = @ ) .", "posting alcohol-related content on social media platforms such as facebook is associated with common motivations for drinking and is , in itself , a strong predictive indicator of drinking outcomes independent of drinking motives .", "moreover , self-related posting activity appears to be more predictive than facebook friends ' activity .", "these findings suggest that social media platforms may be a useful target for future preventative and intervention efforts ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "we aimed to compare the effectiveness of intravenous piracetam with that of intravenous dimenhydrinate in the treatment of acute peripheral vertigo in the emergency department .", "this double-blind study comprised a total of @ patients , aged between @ and @ years , who had presented to the emergency department of ankara training and research hospital and were diagnosed with peripheral vertigo .", "evaluation of the severity of the patients ' vertigo was performed using a visual analogue scale , before and after drug administration .", "both drugs were found to be effective ( p < @ ) and had comparable effects ( p < @ ) .", "dimenhydrinate was also found to have about two times the side effects of piracetam .", "drowsiness was found to be the most common side effect of these two drugs .", "dimenhydrinate and piracetam have similar levels of effectiveness with regard to acute vertigo .", "we conclude that piracetam , which has fewer side effects than dimenhydrinate , better vestibular compensation , and is effective for both acute and chronic vertigo , could be more frequently used in the emergency treatment of acute vertigo ." ]

[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "chronic constipation is frequent in children .", "the objective of this study is to compare the efficacy and safety of peg @ and lactulose for the treatment of chronic constipation in young children .", "this randomised , double-blind study enrolled @ young children aged @ to @ months , who were randomly assigned to receive lactulose ( @ g per day ) or peg @ ( @ g per day ) for four weeks .", "the primary efficacy variable was stool frequency during the fourth week of treatment .", "secondary outcomes were the number and frequency of subjective symptoms associated with defecation at each visit .", "stool frequency was comparable in the two groups at baseline ( lactulose : @ @ ; peg @ : @ @ ) .", "mean stool frequency increased from @ @ stools/day at baseline to @ @ at week @ in the lactulose group and from @ @ to @ @ stools/day in the peg @ group .", "a significant difference was observed in the adjusted mean change from baseline , which was @ stools/day in the lactulose group and @ stools/day in the peg @ group , with a least-squares mean difference of @ stools/day -lsb- @ % ci : @ to @ -rsb- .", "with respect to secondary outcome variables , stool consistency and ease of stool passage improved more in the peg @ group ( p = @ ) .", "the incidence of adverse events was similar in both groups , the majority of which were mild .", "peg @ has superior efficacy to lactulose for the treatment of chronic constipation in young children and is well tolerated .", "us national institute of health clinical trials database ; study nct@ first registered @th november @ ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]