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

[ "polyunsaturated phospatidyl-choline ( ppc ) has been shown to reduce serum aminotransferases in experimental hepatitis .", "this multi-center , randomized , double-blind , placebo-controlled trial evaluated the effects of ppc in patients with chronic hepatitis b and c in combination with interferon alpha @a or @b .", "the diagnosis of chronic viral hepatitis was based on an abnormal serum alanine aminotransferase ( alt ) value ( more than twice the upper value of normal ) , viral replication and chronic hepatitis found on liver biopsy .", "patients received @ million i.u. ( hepatitis b ) and @ million i.u. ( hepatitis c ) interferon s.c. thrice weekly for @ weeks , respectively , and were randomly assigned to additional oral medication with either @ capsules of ppc ( total daily dose : @ g ) or @ capsules of placebo per day for @ weeks .", "biochemical response to therapy was defined as a reduction of alt by more than @ % of pre-treatment values .", "the responders were treated for further @ weeks after cessation of interferon therapy with either ppc or placebo .", "@ patients completed the study protocol ( per-protocol population : @ in the ppc and @ in the placebo group ) .", "a biochemical response ( > @ % alt reduction ) was seen in @ % of patients who were treated with ppc , but only in @ % of patients who received placebo ( p < @ ) .", "ppc increased the response rate in particular in patients with hepatitis c : @ % of those patients responded in the ppc group versus @ % in the placebo group ( p < @ ) .", "prolonged ppc therapy given to responders beyond the cessation of interferon therapy tended to increase the rate of sustained responders at week @ in patients with hepatitis c ( @ % versus @ % in the control group ; p = @ ) .", "in contrast , ppc did not alter the biochemical response to interferon in patients with hepatitis b. ppc did not accelerate elimination of hbv-dna , hbeag and hcv-rna .", "in conclusion , ppc may be recommended in patients with chronic hepatitis c in combination with interferon and after termination of interferon in order to reduce the high relapse rate .", "ppc may not be recommended for patients with chronic hepatitis b.", "in contrast to ifn and other antiviral agents ppc does not carry major risks and is tolerated very well ." ]

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

[ "the subjective and psychomotor effects of remifentanil have not been evaluated .", "accordingly , the authors used mood inventories and psychomotor tests to characterize the effects of remifentanil in healthy , non-drug-abusing volunteers .", "alfentanil was used as a comparator drug .", "ten healthy volunteers were enrolled in a randomized , double-blinded , placebo-controlled , crossover trial in which they received an infusion of saline , remifentanil , or alfentanil for @ min .", "the age - and weight-adjusted infusions ( determined with stanpump , a computer modeling software package ) were given to achieve three predicted constant plasma levels for @ min each of remifentanil ( @ , @ , and @ ng/ml ) and alfentanil ( @ , @ , and @ ng/ml ) .", "mood forms and psychomotor tests were completed , and miosis was assessed , during and after the infusions .", "in addition , analgesia was tested at each dose level using a cold-pressor test .", "remifentanil had prototypic micro-like opioid subjective effects , impaired psychomotor performance , and produced analgesia .", "alfentanil at the dose range tested had more mild effects on these measures , and the analgesia data indicated that a @:@ potency ratio , rather than the @:@ ratio we used , may exist between remifentanil and alfentanil .", "a psychomotor test administered @ min after the remifentanil infusion was discontinued showed that the volunteers were still impaired , although they reported feeling no drug effects .", "the notion that the pharmacodynamic effects of remifentanil are extremely short-lived after the drug is no longer administered must be questioned given our findings that psychomotor effects were still apparent @ h after the infusion was discontinued ." ]

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

[ "radical radiotherapy is commonly used to treat localised prostate cancer .", "late chronic side-effects limit the dose that can be given , and may be linked to the volume of normal tissues irradiated .", "conformal radiotherapy allows a smaller amount of rectum and bladder to be treated , by shaping the high-dose volume to the prostate .", "we assessed the ability of this new technology to lessen the risk of radiation-related effects in a randomised controlled trial of conformal versus conventional radiotherapy .", "we recruited men with prostate cancer for treatment with a standard dose of @ gy in daily @ gy fractions .", "the men were randomly assigned conformal or conventional radiotherapy treatment .", "the primary endpoint was the development of late radiation complications ( > @ months after treatment ) measured with the radiation therapy and oncology group ( rtog ) score .", "indicators of disease ( cancer ) control were also recorded .", "in the @ men treated , significantly fewer men developed radiation-induced proctitis and bleeding in the conformal group than in the conventional group ( @ vs @ % > or = rtog grade @ , p = @ ; @ vs @ % > or = rtog grade @ , p = @ ) .", "there were no differences between groups in bladder function after treatment ( @ vs @ % > or = grade @ , p = @ ; @ vs @ % > or = grade @ , p = @ ) .", "after median follow-up of @ years there was no significant difference between groups in local tumour control ( conformal @ % [ @ % ci @-@ ] , conventional @ % [ @-@ ] ) .", "conformal techniques significantly lowered the risk of late radiation-induced proctitis after radiotherapy for prostate cancer .", "widespread introduction of these radiotherapy treatment methods is appropriate .", "our results are the basis for dose-escalation studies to improve local tumour control ." ]

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

[ "antiretroviral therapy is complicated by drug interactions and contraindications .", "novel regimens are needed .", "this open label study randomly assigned treatment-naive , human immunodeficiency virus ( hiv ) - infected subjects to receive tenofovir-emtricitabine with efavirenz ( arm i ) , with ritonavir-boosted atazanavir ( arm ii ) , or with zidovudine/abacavir ( arm iii ) .", "pair-wise comparisons of differences in time-weighted mean change from baseline plasma hiv-rna to week @ formed the primary analysis .", "treatment arms were noninferior if the upper limit of the @ % confidence interval ( ci ) was < @ log ( @ ) copies/ml .", "secondary objectives included virologic , immunologic and safety end points .", "the intention-to-treat population comprised @ patients ( arm i , n = @ ; arm ii , n = @ ; and arm iii , n = @ ) .", "noninferiority for the primary end point was established .", "analysis for superiority showed that arm iii was significantly less potent than arm i ( -@ log ( @ ) copies/ml ; @ % ci , -@ to -@ log ( @ ) copies/ml ; p = @ ) .", "the proportions of patients on each of arm i ( @ % ) and arm ii ( @ % ) with < @ copies/ml were not different ( p = @ ) , but the percentage of patients in arm iii with < @ copies/ml ( @ % ) was significantly lower ( p = @ ) .", "cd@ + cell counts did not differ .", "serious adverse events were more frequent in arm iii ( n = @ ) than in arm i or arm ii ( n = @ for each ; p = @ ) .", "a novel quadruple nucleo ( t ) side combination demonstrated significantly less suppression of hiv replication , compared with the suppression demonstrated by standard antiretroviral therapy regimens , although it did meet the predetermined formal definition of noninferiority .", "secondary analyses indicated statistically inferior virologic and safety performance .", "efavirenz and ritonavir-boosted atazanavir arms were equivalent in viral suppression and safety ." ]

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

[ "the aim of this study was to describe blood pressure responses during resistance exercise in hypertensive subjects and to determine whether an exercise protocol alters these responses .", "resistance exercise has been recommended as a complement for aerobic exercise for hypertensive patients .", "however , blood pressure changes during this kind of exercise have been poorly investigated in hypertensives , despite multiple studies of normotensives demonstrating significant increases in blood pressure .", "ten hypertensive and ten normotensive subjects performed , in random order , two different exercise protocols , composed by three sets of the knee extension exercise conducted to exhaustion : @ % of the @-repetition maximum ( @rm ) with a @-s rest between sets , and @ % of @rm with a @-s rest between sets .", "radial intra-arterial blood pressure was measured before and throughout each protocol .", "compared with normotensives , hypertensives displayed greater increases in systolic bp during exercise at @ % ( +@ + / -@ vs. +@ + / -@ mmhg , p < @ ) and at @ % of @rm ( +@ + / -@ vs. +@ + / -@ mmhg , p < @ ) .", "in both exercise protocols , systolic blood pressure returned to baseline during the rest periods between sets in the normotensives ; however , in the hypertensives , bp remained slightly elevated at @ % of @rm .", "during rest periods , diastolic blood pressure returned to baseline in hypertensives and dropped below baseline in normotensives .", "resistance exercise increased systolic blood pressure considerably more in hypertensives than in normotensives , and this increase was greater when lower-intensity exercise was performed to the point of exhaustion ." ]

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

[ "the purpose of this study was to explore the amount of family contact among older persons with serious mental illnesses ( smi ) , and to examine its relationship to health and mental health .", "an analysis of baseline data was conducted from a treatment study including @ adults age @ and older .", "the amount of family contact was examined with descriptive statistics .", "differences in health and mental health were examined between participants with low , moderate , or high levels of family contact .", "analyses also compared these groups on health and mental health functioning , controlling for psychiatric symptoms and the number and severity of medical diseases , respectively .", "over three-quarters of respondents ( @ % ) reported speaking on the phone with a relative and two-thirds ( @ % ) reported seeing a relative at least once during the past month .", "older adults who lived with a family member had more severe mood symptoms and poorer mental health functioning .", "those who lived with family or had moderate levels of family contact had more comorbid diseases and more disease severity than those with less family contact .", "these relationships remained significant after controlling for medical conditions or psychiatric symptoms .", "the majority of older persons have regular family contact and those with the highest levels of family contact appear to have more compromised physical and mental health .", "study findings provide new knowledge for practitioners regarding the importance of using family interventions to target physical health and mental illness management for older consumers who may need assistance to access medical care and treatment .", "further research on the role of families in psychiatric and physical health management will provide a foundation for family interventions aimed at supporting community living among older adults ." ]

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

[ "pharmacological benefits of glutamine supplementation have been shown in athletically and clinically stressed human subjects .", "in the horse , infection and intense exercise have also been shown to significantly decrease plasma glutamine concentrations , but little is known on how best to supplement .", "to evaluate whether ingestion of different foodstuffs , with or without l-glutamine ( g ) or a peptide ( pep ) containing @ % w/w g in a water-stable form , could affect plasma glutamine concentrations ( p-gc ) .", "nine feeds ( molassed sugar beet-pulp ( msb ) ; naked oats ( no ) ; commercial mix ( cm ) ; msb with @ or @ mg/kg bwt g or the g-molar equivalent of pep ; and cm with @ mg/kg bwt g or equivalent pep ) were offered to @ healthy mature horses on different days following overnight food restriction .", "the changes in p-gc were monitored for @ h post feeding .", "after @ h mean + / - s.d. ap-gc were -@ + / - @ % ( msb ) , +@ + / - @ % ( no ) and +@ + / - @ % ( cm ; p < @ ) .", "deltap-gc with msb supplemented with g was +@ + / - @ % ( @ mg ; p < @ ) and +@ + / - @ % ( @ mg ; p < @ ) at @ h ; deltap-gc with pep was @ + / - @ % ( @ mg equivalent , p < @ ) and +@ + / - @ % ( @ mg equivalent , p < @ ) at @ h.", "after @ days of supplementation with @ mg/kg bwt g , ap-gc following a further @ mg/kg bwt g challenge showed a similar increase at @ h of +@ + / - @ % ; prevalues were unchanged .", "g and pep added to cm , increased p-gc by @ + / - @ ( +@ % ) and @ + / - @ micromol/l ( @ % ) at @ h with concentrations still above prevalues at @ h ( p < @ ) .", "apart from the cm ( with or without supplement ) , pre p-gc was always regained by @ h. plasma nh@ and plasma protein concentrations were unaffected by supplementation with g or pep .", "p-gc may be modified by appropriate supplementation with no apparent adverse effects .", "increasing p-gc through appropriate supplementation may be of benefit in the athletically or clinically stressed horse with lowered plasma glutamine concentrations ." ]

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

[ "develop and validate limited-sampling strategy ( lss ) models for estimating the area under the plasma concentration versus time curve ( auc ) of amlodipine , using data from a bioequivalence study .", "sixteen healthy volunteers received single @-mg oral doses of amlodipine , as reference or test formulation , at a @-day interval , in a randomized , crossover protocol .", "plasma concentrations of amlodipine ( n = @ ) , measured by mass spectrometry , were used to develop lss models .", "linear regression analysis of the auc@-@ and a `` jack-knife '' validation procedure revealed that lss models based on two sampling times ( @ h and @ h ) predict accurately ( r@ = @ ; bias < @ % ; precision = @ % ) the auc@-@ of amlodipine for each formulation .", "validation tests indicate that the @-point lss model developed for the reference formulation predicts accurately ( r@ > @ ) : ( a ) the individual auc@-@ for the test formulation in the same group of volunteers ; ( b ) the individual auc@-@ for the same reference formulation in another bioequivalence study in brazilian volunteers ; ( c ) the average auc@-@ reported in seven additional international studies performed under protocols similar to the present investigation ; ( d ) the individual auc@-@ corresponding to concentration data points provided by a first-order compartmental pharmacokinetic model , when the relative values of either the absorption rate ( kabs ) or the bioavailability ( f ) model parameters were set at @ or @ , of their respective original values .", "the @-point lss models developed in the current study predict accurately the auc of amlodipine under a variety of experimental conditions and , thus , may be valuable for exploring the relationships between the pharmacokinetics and pharmacodynamics of this calcium antagonist , at reduced costs of sample acquisition and analysis , and avoiding sampling at `` unsociable '' hours ." ]

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

[ "few strategies are available for the prevention of cognitive impairment in elderly persons .", "serum lipoprotein levels may be important predictors of cognitive function , and drugs that lower cholesterol may be effective for the prevention of cognitive impairment .", "to determine whether serum lipoprotein levels , the @-year change in serum lipoprotein levels , and the use of statin drugs are associated with cognition in older women without dementia .", "an observational study of @ postmenopausal women with coronary heart disease enrolled in the heart and estrogen/progestin replacement study ( participants at @ of @ centers ) .", "the modified mini-mental state examination was administered at the end of the study after @ years of follow-up .", "women whose score was less than @ points ( > @ sds below the mean ) were classified as having cognitive impairment .", "lipoprotein levels ( total , high-density lipoprotein , and low-density lipoprotein [ ldl ] cholesterol and triglycerides ) were measured at baseline and at the end of the study ; statin use was documented at each visit .", "compared with women in the lower quartiles , women in the highest ldl cholesterol quartile at cognitive testing had worse mean plus minus sd modified mini-mental state examination scores ( @ plus minus @ vs @ plus minus @ ; p = @ ) and an increased likelihood of cognitive impairment ( adjusted odds ratio , @ ; @ % confidence interval , @-@ @ ) .", "a reduction in the ldl cholesterol level during the @ years tended to be associated with a lower odds of impairment ( adjusted odds ratio , @ ; @ % confidence interval , @-@ @ ) compared with women whose levels increased .", "higher total and ldl cholesterol levels , corrected for lipoprotein ( a ) levels , were also associated with a worse modified mini-mental state examination score and a higher likelihood of impairment , whereas high-density lipoprotein cholesterol and triglyceride levels were not associated with cognition .", "compared with nonusers , statin users had higher mean plus minus sd modified mini-mental state examination scores ( @ plus minus @ vs @ plus minus @ ; p = @ ) and a trend for a lower likelihood of cognitive impairment ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , findings that seemed to be independent of lipid levels .", "high ldl and total cholesterol levels are associated with cognitive impairment , and lowering these lipoprotein levels may be a strategy for preventing impairment .", "the association between statin use and better cognitive function in women without dementia requires further study ." ]

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

[ "analysing and presenting data on different outcomes after sick-leave is challenging .", "the use of extended statistical methods supplies additional information and allows further exploitation of data .", "four hundred and fifty-seven patients , sick-listed for @-@ weeks for low back pain , were randomized to intervention ( n = @ ) or control ( n = @ ) .", "outcome was measured as : `` sick-listed '' , `` returned to work '' , or `` disability pension '' .", "the individuals shifted between the three states between one and @ times ( mean @ times ) .", "in a multi-state model , shifting between the states was set up in a transition intensity matrix .", "the probability of being in any of the states was calculated as a transition probability matrix .", "the effects of the intervention were modelled using a non-parametric model .", "there was an effect of the intervention for leaving the state sick-listed and shifting to returned to work ( relative risk ( rr ) = @ , @ % confidence interval ( ci ) @ - @ ) .", "the nonparametric estimates showed an effect of the intervention for leaving sick-listed and shifting to returned to work in the first @ months .", "we found a protective effect of the intervention for shifting back to sick-listed between @ and @ months .", "the analyses showed that the probability of staying in the state returned to work was not different between the intervention and control groups at the end of the follow-up ( @ years ) .", "we demonstrate that these alternative analyses give additional results and increase the strength of the analyses .", "the simple intervention did not decrease the probability of being on sick-leave in the long term ; however , it decreased the time that individuals were on sick-leave ." ]

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

[ "the purpose of this study was to compare the cost of percutaneous coronary intervention ( pci ) using bivalirudin with provisional platelet glycoprotein ( gp ) iib/iiia inhibition with that of heparin + routine gp iib/iiia inhibition .", "although gp iib/iiia inhibition has been shown to reduce ischemic complications in a broad range of patients undergoing pci , many patients currently do not receive such therapy because of concerns about bleeding complications or cost .", "recently , bivalirudin with provisional gp iib/iiia inhibition has been validated as an alternative to heparin + routine gp iib/iiia inhibition for patients undergoing pci .", "however , the cost-effectiveness of this novel strategy is unknown .", "in the randomized evaluation in pci linking angiomax to reduced clinical events ( replace ) -@ trial , @,@ u.s. patients undergoing non-emergent pci were randomized to receive bivalirudin with provisional gp iib/iiia ( n = @,@ ) versus heparin + routine gp iib/iiia ( n = @,@ ) .", "resource utilization data were collected prospectively through @-day follow-up on all u.s. patients .", "medical care costs were estimated using standard methods including bottom-up accounting ( for procedural costs ) , the medicare fee schedule ( for physician services ) , hospital billing data ( for @,@ of @,@ admissions ) , and regression-based approaches for the remaining hospitalizations .", "among the bivalirudin group , @ % required provisional gp iib/iiia .", "thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and gp iib/iiia groups , but bivalirudin resulted in lower rates of major bleeding ( @ % vs. @ % , p = @ ) and minor bleeding ( @ % vs. @ % , p < @ ) .", "compared with routine gp iib/iiia , in-hospital and @-day costs were reduced by $ @ ( @ % confidence interval [ ci ] $ @ to $ @ ) and $ @ ( @ % ci $ @ to $ @ ) per patient with bivalirudin ( p < @ for both ) .", "regression modeling demonstrated that , in addition to the costs of the anticoagulants themselves , hospital savings were due primarily to reductions in major bleeding ( cost savings = $ @/patient ) , minor bleeding ( $ @/patient ) , and thrombocytopenia ( $ @/patient ) .", "compared with heparin + routine gp iib/iiia inhibition , bivalirudin + provisional gp iib/iiia inhibition resulted in similar acute ischemic events and cost savings of $ @ to $ @/patient depending on the analytic perspective ." ]

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

[ "to explore the effect of isoflurane preconditioning on the plasma concentration of matrix metalloproteinase ( mmp ) -@ and myocardial ultramicrostructure in patients undergoing cardiac valve replacement .", "thirty patients undergoing elective cardiac valve replacement with cardiopulmonary bypass ( cpb ) were randomly assigned to a control group ( n@ ) and an isoflurane group ( n@ ) .", "in the isoflurane group , isoflurane of @ minimum alveolar concentration end-tidal ( @ % approximately @ % ) was administered for @ min followed by a @ min washout period before the cpb .", "the control group did not inhale isofurane , and there was no difference in the other drugs in the @ groups .", "blood samples for mmp-@ were obtained before incision ( t ( @ ) ) and at @ min ( t ( @ ) ) ,@ h ( t ( @ ) ) ,@ h ( t ( @ ) ) , and @ h ( t ( @ ) ) after the reperfusion .", "right atrial biopsies were collected before and after the cpb to observe the myocardial ultramicrostructure .", "compared with t ( @ ) , the mean mmp-@ level significantly increased at t ( @ ) , t ( @ ) and t ( @ ) in the control group ( p < @ ) , while the mmp-@ level only at t ( @ ) significantly increased in the isoflurane group ( p < @ ) .", "the mean mmp-@ level was significantly reduced in the isoflurane group at t ( @ ) compared with each time point in the control group .", "the difference in mmp-@ levels between t ( @ ) , t ( @ ) , t ( @ ) and t ( @ ) was significantly lower in the isoflurane group than that in the control group ( p < @ ) .", "the ultramicrostructure injury of myocardium under electron microscope in the control group was worse than that in the isoflurane group .", "the plasma concentration of mmp-@ is inhibited by isoflurane preconditioning in patients undergoing cardiac valve replacement after cpb , which might be part of its protective mechanism against myocardium injury after cpb ." ]

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

[ "frame-based stereotactic surgical planning systems ( sspss ) have been used for deep brain stimulation and radioneurosurgery .", "here , we evaluated the feasibility , safety and efficacy of using a ssps to aid spontaneous intracerebral haematoma ( ich ) treatment .", "patients with moderate spontaneous putamen haematomas were randomized into two groups : treatment ( group a ) and control ( group b ) .", "in group b , the catheter for evacuating haematomas was inserted into a target point , located at the centre of the haematoma , using conventional frame-based stereotactics ; urokinase thrombolysis was subsequently delivered through the catheter .", "in group a , this procedure was assisted by a ssps , which designed both the target point and trajectory in the haematoma through virtual reality .", "duration of evacuating haematomas and number of urokinase injections was compared between groups .", "in total , @ patients were recruited : in group a ( n = @ ) , the duration of evacuating haematomas ( @ h ) was shorter than in group b ( n = @ ; @ h ) .", "there were fewer urokinase injections in group a ( @ ) than in group b ( @ ) .", "the feasibility , efficacy and safety of spontaneous ich treatment were optimized by the use of a frame-based ssps ." ]

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

[ "displacement of the heart to expose the posterior vessels during off-pump coronary artery bypass ( opcab ) may cause hemodynamic instability .", "deep pericardial traction suture ( dpts ) and vacuum-assisted apical suction ( vas ) with the starfish positioning device help to provide good exposure without relevant hemodynamic changes .", "our aim was to compare these two methods in patients undergoing multivessel opcab .", "we prospectively randomized @ patients undergoing multivessel opcab to the use of vas or dpts .", "the octopus device was used in both groups to stabilize the target vessel .", "hemodynamic parameters , including venous oxygen content ( svo ( @ ) ) , cardiac index ( ci ) , central venous pressure ( cvp ) , mean arterial pressure ( map ) , pulmonary artery pressure ( pap ) , and pulmonary capillary wedge pressure ( pcwp ) , were measured before grafting ( baseline ) , after heart positioning , and during performance of peripheral anastomoses .", "perioperative data for the two groups were similar .", "during exposure of the lateral wall , there were fewer hemodynamic changes in the dpts group ( increase in cvp ) than in the vas group ( increases in cvp , pap , and pcwp ) ; the cvp was significantly higher in the dpts group ( p < @ ) .", "during exposure of the posterior wall , significant hemodynamic changes occurred only in the dpts group ( increase in pcwp ) .", "values for all other parameters were similar , including anastomosis time , graft flow , postoperative myocardial enzymes , and inotropic support .", "heart positioning during opcab with either vas or dpts is a safe and effective maneuver for exposure of coronary arteries .", "in our study , the use of the vas device produced less hemodynamic impairment during exposure of the lateral and posterior walls ." ]

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

[ "the prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy .", "we did the stomach cancer adjuvant multi-institutional group trial ( samit ) to assess the superiority of sequential treatment ( paclitaxel then tegafur and uracil [ uft ] or paclitaxel then s-@ ) compared with monotherapy ( uft or s-@ ) and also the non-inferiority of uft compared with s-@ .", "we did this randomised phase @ trial with a two-by-two factorial design at @ hospitals in japan .", "we enrolled patients aged @-@ years with t@a or t@b gastric cancer , who had had d@ dissection and a ecog performance score of @-@ .", "patients were randomly assigned to one of four treatment groups with minimisation for tumour size , lymph node metastasis , and study site .", "patients received uft only ( @ mg/m ( @ ) per day ) , s-@ only ( @ mg/m ( @ ) per day ) for @ days , with a @-day rest period or three courses of intermittent weekly paclitaxel ( @ mg/m ( @ ) ) followed by either uft , or s-@ .", "treatment lasted @ weeks in monotherapy groups and @ weeks in the sequential treatment groups .", "the primary endpoint was disease-free survival assessed by intention to treat .", "we assessed whether uft was non-inferior to s-@ with a non-inferiority margin of @ .", "this trial was registered at umin clinical trials registry , number c@ .", "we randomly assigned @ patients between aug @ , @ , and sept @ , @ patients were assigned to receive uft alone , @ to receive s-@ alone , @ to received paclitaxel then uft , and @ to receive paclitaxel then s-@ .", "we included @ patients in the primary analysis after at least @ years of follow-up ( @ , @ , @ , and @ in each group respectively ) .", "protocol treatment was completed by @ ( @ % ) patients in the uft group , @ ( @ % ) in the s-@ group , @ ( @ % ) in the paclitaxel then uft group , and @ ( @ % ) in the paclitaxel then s-@ group .", "@-year disease-free survival for monotherapy was @ % ( @ % ci @-@ ) and that of sequential treatment was @ % ( @-@ ; hazard ratio [ hr ] @ , @ % ci @-@ , p = @ ) .", "@-year disease-free survival for the uft group was @ % ( @ % ci @-@ ) and that of the s-@ group was @ % ( @-@ ; hr @ , @ % ci @-@ , p = @ ; pnon-inferiority = @ ) .", "the most common grade @-@ haematological adverse event was neutropenia ( @ [ @ % ] of @ patients in the uft group , @ [ @ % ] of @ in the s-@ group , @ [ @ % ] of @ in the paclitaxel then uft group , and @ [ @ % ] of @ in the paclitaxel then s-@ group ) .", "the most common grade @-@ non-haematological adverse event was anorexia ( @ [ @ % ] , @ [ @ % ] , seven [ @ % ] , and @ [ @ % ] , respectively ) .", "sequential treatment did not improve disease-free survival , and uft was not non-inferior to s-@ ( and s-@ was superior to uft ) , therefore s-@ monotherapy should remain the standard treatment for locally advanced gastric cancer in japan .", "epidemiological and clinical research information network ." ]

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

[ "to evaluate the effects of a lifestyle intervention programme in primary healthcare , targeted to patients with moderate to high risk of cardiovascular disease in terms of cardiovascular risk factors , physical activity , and quality of life .", "randomized controlled trial with one-year follow-up , carried out in a primary healthcare centre in northern sweden .", "a total of @ middle-aged men and women , with hypertension , dyslipidemia , type @ diabetes , or obesity were enrolled .", "the subjects were randomized to either the intervention ( n = @ ) or the control group ( n = @ ) .", "a total of @ subjects completed the one-year follow-up .", "exercise : supervised endurance and circuit training in groups three times a week for three months .", "diet : five group sessions of diet counselling with a dietitian .", "follow - up meetings with a physiotherapist were conducted monthly thereafter .", "primary outcomes were changes in anthropometry , maximal oxygen uptake , health-related quality of life , and self-reported physical activity .", "the secondary outcomes were changes in blood pressure and metabolic variables .", "after one year the intervention group significantly increased maximal oxygen uptake , physical activity , and quality of life and significantly decreased body weight , waist and hip circumference , body mass index , waist-hip ratio , systolic and diastolic blood pressure , triglycerides , and glycosylated haemoglobin .", "there were significant differences between groups , mean changes ( and their @ % confidence intervals , ci ) in waist circumference -@ cm ( -@ to -@ ; p < @ ) , in waist-hip ratio -@ ( -@ to -@ ; p < @ ) and in diastolic blood pressure -@ mmhg ( -@ to -@ ; p < @ ) .", "a prevention programme in primary healthcare with a focus on physical activity and diet counselling followed by structured follow-up meetings can favourably influence several risk factors for cardiovascular diseases and quality of life in high-risk subjects for at least one year ." ]

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

[ "to assess the impact of two methods of brief nurse-delivered brief interventions in reducing drinking variables in hazardous drinkers with alcohol-related facial injuries .", "a randomised controlled trial of two brief interventions involving hazardous drinkers with facial trauma in three oral and maxillofacial surgery outpatient clinics in the west of scotland ; @ patients were recruited and randomised to have either a nurse-led brief motivational intervention ( intervention group ) or a leaflet about alcohol misuse ( control group ) .", "patients were followed up at @ and @ months after the intervention and drinking variables reassessed .", "a brief motivational intervention for alcohol provided by a nurse was more effective than a leaflet in helping some patients with facial trauma to reduce their alcohol consumption @ months after the intervention ( p < @ ) .", "facial trauma in the west of scotland is strongly associated with alcohol misuse and is a recurrent disease , particularly among those who drink heavily .", "a nurse-delivered brief motivational intervention is effective in helping patients with high scores in the alcohol use disorders identification test to reduce their drinking , and this effect was apparent @ months after the intervention ." ]

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

[ "procedural burn pain is the most intense acute pain and most likely type of burn injury pain to be undertreated due to the physician 's fear of the adverse effect of analgesia and lack of anesthetist present .", "at our institution , in most of the cases , local burn detersion and debridement were performed at the ward level without any analgesics .", "this article describes a study designed to test the analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain .", "the experiment was carried out in three centers .", "the patients were given a number from @ to @ .", "a randomization list was produced by a statistician according to our preliminary study .", "due to the severity of the pain suffered , ethically it was decided to help as many as possible , so patients given the letters a , b or c were treated using a canister with the appropriate letter containing preprepared nitrous oxide/oxygen mixture ( noom ) .", "those with d were given oxygen only , from an identical-looking canister labeled d. neither patients , nor doctors , nor nurses , nor data collector knew what was in each canister , thus they were all blind .", "the nursing officer who implemented the intervention handed the doctors envelopes containing the patients ' name and allocation of a , b , c or d. thus , patients receiving noom or oxygen were in the ratio @:@ .", "parameters , including pain severity , blood pressure , heart rate , digital oxygen saturation and the chinese version of the burn specific pain anxiety scale ( c-bspas ) , were taken before , during and after dressing for each group .", "a video and audio record was taken individually for later communication coding and outcome analysis .", "rescue analgesic was recorded .", "based on the findings from our previous qualitative study that physician 's reluctance to order narcotic analgesia is due to its adverse effect and from our pilot experiment , this study aims to test the hypothesis that a fixed nitrous oxide/oxygen mixture will promote better burn dressing pain alleviation and outcomes .", "analyses will focus on the effects of the experimental intervention on pain severity during dressing ( primary outcomes ) ; physiological parameters , c-bspas and acceptance of both health care professionals and patients ( secondary outcomes ) .", "if this model of analgesia for burn pain management implemented by nurses proves successful , it could potentially be implemented widely in hospital and prehospital settings and improve patients ' satisfaction and quality of life .", "( clinical trials identifier : chictr-trc@ ) ." ]

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

[ "whilst there is data to support the use of melatonin in treating disorders of the sleep-wake cycle , so far there is little published evidence on the efficacy of melatonin in treating the prevalent condition of post-tbi sleep disturbance .", "the present work used a randomized double-blind controlled cross-over trial to compare melatonin ( @ mg ) and amitriptyline ( @ mg ) in a small sample of tbi patients presenting with chronic sleep disturbance .", "no differences in sleep latency , duration , quality or daytime alertness were found for either drug compared to baseline using significance testing .", "however , effect sizes revealed some encouraging changes .", "patients on melatonin reported improved daytime alertness compared to baseline .", "on amitriptyline , patients reported increased sleep duration compared to baseline .", "the study provides preliminary evidence for the value of melatonin and amitriptyline in treating sleep disorder post-tbi .", "there were no adverse drug effects .", "suggestions are made for ongoing investigation for the treatment of this prevalent condition ." ]

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

[ "to evaluate the clinical value of two alimentary reconstruction methods after total gastrectomy for gastric cancer .", "thirty - one patients undergoing total gastrectomy for gastric cancer were prospectively randomly divided into two groups : single-canal jejunum interposition ( n = @ , group a ) and p pouch with roux-en-y esophagojejunostomy ( n = @ , group b ) .", "all patients were followed up for one year .", "the serum nutritional parameters , body weight change and clinical effects between the two groups were compared .", "both of the reconstruction types had the replacement of gastric function .", "the hemoglobin level was ( @ + / - @ ) g/l , the total protein level ( @ + / - @ ) g/l , and the body weight loss ( @ + / - @ ) kg in group a , while ( @ + / - @ ) g/l , ( @ + / - @ ) g/l and ( @ + / - @ ) kg in group b.", "there were significant differences between the two groups ( all p < @ ) .", "the single-canal jejunum interposition reconstruction after total gastrectomy ( henley ) is a better surgical method ." ]

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

[ "to assess the efficacy and safety of hemodilution combined with induced hypotension during surgery .", "randomized , nonblinded , controlled study .", "operating room suite and intensive care unit ( icu ) at a university hospital .", "@ asa physical status i and ii patients who underwent general or general plus epidural anesthesia for major orthopedic surgery .", "in group @ ( n = @ ) , mean arterial blood pressure ( map ) was decreased to @ mmhg by increasing the inspired concentration of isoflurane and injecting @ mg of @ % bupivacaine into the epidural catheter .", "hematocrit was decreased to @ % by phlebotomy and simultaneous infusion of crystalloid and colloid .", "in group @ ( n = @ ) , isoflurane was adjusted to maintain map within @ % of baseline values , and no phlebotomy or hemodilution was used .", "efficacy of hemodilution combined with induced hypotension ( group @ ) was compared to standard management of blood volume and pressure ( group @ ) by measuring transfusion volume and length of icu stay .", "safety of hemodilution/hypotension was determined by measuring the electroencephalogram , internal jugular venous oxygen saturation , the electrocardiogram , and central venous oxygen saturation .", "in group @ , both the volume of homologous blood ( @ + / - @ ml ) and total blood ( @ + / - @ ml ) was significantly less than the volume of homologous blood transfused in group @ ( @ + / - @ ml ) .", "no patients in group @ , but all patients in group @ required icu admission ( @ + / - @ days ) for treatment to prevent sequelae from , or progression of , moderate-severe tissue edema and metabolic acidosis .", "cerebral and myocardial measures were not significantly different between groups .", "hemodilution combined with induced hypotension was safe and may reduce the need for transfusion and icu admission ." ]

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

[ "to examine blood pressure circadian rhythm in subjects with chronic fatigue syndrome ( cfs ) and appropriate normal and fatigued controls to correlate parameters of blood pressure regulation with perception of fatigue in an observational cohort study .", "the cause of cfs remains unknown and there are no effective treatments .", "to address whether inactivity was a confounder , we performed a @-hour ambulatory blood pressure monitoring in the following three subject groups : @ ) cfs patients ( fukuda diagnostic criteria ) ( n = @ ) ; @ ) normal controls ( n = @ ) ; and @ ) a fatigue comparison group ( n = @ ) with the autoimmune liver disease primary biliary cirrhosis ( pbc ) .", "all patients completed a measure of fatigue severity ( fatigue impact scale ) .", "in view of the different demographics between the patient groups , patients were age - and sex-matched on a case-by-case basis to normal controls and blood pressure parameters were compared .", "compared with the control population , the cfs group had significantly lower systolic blood pressure ( p < @ ) and mean arterial blood pressure ( p = @ ) and exaggerated diurnal variation ( p = @ ) .", "there was a significant inverse relationship between increasing fatigue and diurnal variation of blood pressure in both the cfs and pbc groups ( p < @ ) .", "lower blood pressure and abnormal diurnal blood pressure regulation occur in patients with cfs .", "we would suggest the need for a randomized , placebo-controlled trial of agents to increase blood pressure such as midodrine in cfs patients with an autonomic phenotype ." ]

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

[ "to compare a single periovulatory intrauterine insemination ( iui ) with a regimen employing two iuis , one before ovulation and one after ovulation , in patients undergoing controlled ovarian hyperstimulation with human menopausal gonadotropins ( hmg ) combined with human chorionic gonadotropin ( hcg ) .", "a randomized , prospective trial .", "thirty-one consecutive patients undergoing @ cycles of controlled ovarian hyperstimulation/iui were studied in a tertiary care setting .", "ovulation was determined sonographically .", "the establishment of a clinical pregnancy was defined by either ultrasonographic verification of cardiac activity within an intrauterine fetus , or histologic confirmation of trophoblast in a surgical specimen .", "clinical pregnancies developed in @ of @ cycles in the single insemination group , compared with @ of the @ cycles in the double insemination group .", "cycle fecundity was significantly higher for group ii ( @ ) than for group i ( @ ) patients ( p = @ ) .", "in hmg/hcg cycles , two iuis timed as described above are superior to one periovulatory insemination ." ]

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

[ "to investigate the safety , tolerability and efficacy of rivastigmine capsules ( @-@ mg/day ) in a @-week , multi-centre , open-label extension of a double-blind study .", "patients with traumatic brain injury ( tbi ) and persistent cognitive impairment who had received rivastigmine ( @-@ mg/day ) or placebo for @ weeks could enter the extension study and receive rivastigmine ( < or = @ mg/day ) .", "patients were assessed using a range of cognitive tests including the hopkins verbal learning test ( hvlt ) and the cambridge neuropsychological test automated battery rapid visual information processing ( cantab rvip ) a ' sub-test .", "safety measures included monitoring of adverse events .", "in the extension study ( n = @ ) , the mean duration of rivastigmine treatment was @ weeks and the mean final dosage was @ mg/day .", "approximately @ % of patients were responders ( > or = @ sd improvement from baseline ) on cantab rvip a ' or hvlt total score at week @ or endpoint .", "statistically significant changes from week @ at week @ were observed for cantab-rvip a ' and hvlt-total word recall for the sub-group of ex-placebo patients with greater severity of initial impairment .", "the safety profile of rivastigmine capsules was consistent with the label .", "treatment with rivastigmine for up to @ weeks was safe in patients with tbi and cognitive impairment ." ]

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

[ "every member of healthcare personnel should be able to perform basic life support including defibrillation ( cpr-d ) .", "the biggest cost of implementation is training and these costs need to be reduced .", "the purpose of this randomized study was to evaluate the applicability of distance learning as a method to teach cpr-d .", "nurses ( n = @ ) working in a geriatric hospital were randomized into three groups .", "the first group was given the internet-based cpr-d course and the second was given a traditional , small-group cpr-d course .", "a third group without specific training in cpr-d served as a control group .", "an objective structured clinical examination ( osce ) was performed @ weeks after the courses with a manikin patient having a cardiac arrest .", "the median score of all participants was @/@ ( range @-@ ) .", "the reliability of the checklist was adequate ( cronbach alpha @ ) .", "nurses receiving traditional cpr-d performed better than those receiving the internet-based course ( median score @ vs. @ , p < @ ) and the control group ( median score @ vs. @ , p < @ ) .", "nurses receiving internet-based course performed similarly as the control group ( median score @ vs. @ , ns ) .", "distance learning can not substitute for traditional small-group learning ." ]

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

[ "to determine if a new , single-sample device ( eswab ; copan diagnostics , inc ) can simplify the traditional multi-sample approach to specimen collection in infectious keratitis .", "prospective , diagnostic test evaluation .", "in this institutional study , patients with suspected infectious keratitis meeting traditional criteria for diagnostic corneal specimen collection and culture were randomized to the order of first specimen collection method : eswab or a sample directly plated for growth on chocolate agar .", "this was followed by standard samples for blood agar , gram stain , sabouraud agar , thioglycolate broth , and brain heart infusion broth in all cases .", "the specimens collected using the @ approaches were analyzed separately by the laboratory in a masked fashion .", "the main outcome measure was positive growth on cultured media .", "eighty-one eyes from @ consecutive patients were sampled .", "culture positivity rate for the multi-sample method and eswab was @ % and @ % , respectively , with a @ % agreement rate .", "eswab sensitivity was @ % ( @ % confidence interval [ ci ] : @ % -@ % ) , with a specificity of @ % ( @ % ci : @ % -@ % ) .", "positive and negative predictive values of the eswab were @ % ( @ % ci : @ % -@ % ) and @ % ( @ % ci : @ % -@ % ) , respectively .", "there was no difference in positive culture reports with respect to the order of specimen collection technique used .", "the single-sample eswab method is a more accessible and less cumbersome approach to corneal culturing for ophthalmologists , particularly those in the community setting who do not have access to the full set of traditional culture materials .", "culture results using this single-sample approach were comparable to the multi-sample method ." ]

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

[ "low levels of vitamin d are associated with asthma severity , airway remodeling , and exacerbation rate increase , especially in nonatopic asthma .", "reduced steroid responsiveness or impaired antimicrobial defense might be underlying mechanisms .", "we sought to evaluate the effect of vitamin d supplementation on eosinophilic and neutrophilic airway inflammation in patients with nonatopic asthma .", "in a double-blind , randomized , placebo-controlled trial , we investigated the effect of long-acting vitamin d@ ( @,@ iu ) on sputum neutrophils and eosinophils in @ patients with nonatopic asthma with neutrophilic ( @ % ) and/or eosinophilic ( @ % ) airway inflammation .", "sputum induction was performed at baseline and after @ weeks .", "other measurements included questionnaires , blood samples , and pulmonary function .", "treatment with vitamin d did not significantly affect sputum neutrophils or eosinophils compared with treatment with placebo in the total group .", "regarding sputum eosinophils , the effect of vitamin d appeared to be dependent on baseline sputum eosinophil levels ( interaction p = @ ) .", "in patients with eosinophil levels of @ % or more ( median in patients with sputum eosinophilia , > @ % ) , eosinophils decreased from a median of @ % to @ % after vitamin d treatment as compared with an increase from @ % to @ % in patients receiving placebo ( p = @ ) .", "vitamin d treatment also resulted in slightly better asthma control questionnaire scores ( p = @ ) .", "vitamin d supplementation reduced eosinophilic airway inflammation in patients with nonatopic asthma with severe eosinophilic airway inflammation , but did not affect sputum neutrophils .", "also , a small effect on asthma control was observed .", "these findings suggest that vitamin d might have potential as an add-on treatment option in eosinophilic asthma ." ]

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

[ "to compare the efficacy of two surgical techniques for controllong nasal width after le fort i osteotomy .", "fifty-five patients who received the le fort i osteotomy have been included in this study .", "they were randomly divided into @ groups .", "the experimental group received extraoral abs , and the control group received traditional intraoral abs .", "@d photos of the patient 's face were taken before operation and at postoperative @ months .", "alar width was measured on the @d photos .", "data was reported as means and standard deviations , and statistic analysis was done by using student t test .", "compared with presurgical data , g. lat-g .", "lat increased by ( @ + / - @ ) mm , al-al increased by ( @ + / - @ ) mm and sbal-sbal increased by ( @ + / - @ ) mm in experimental group .", "g. lat-g .", "lat increased by ( @ + / - @ ) mm , al-al increased by ( @ + / - @ ) mm and sbal-sbal increased by ( @ + / - @ ) mm in the control group .", "there was significant difference between two groups .", "the surgical technique of abs is the most important factor for determining the postoperative alar width .", "both techniques have better effect on the sbal-sbal width control than the g. lat-g .", "lat and al-al width control .", "traditional intraoral abs can more effectively control the alar width .", "both techniques can not completely control the alar base widening after le fort i osteotomy ." ]

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

[ "the involvement of the central cholinergic system in alcohol abuse behavior is well known .", "it is possible that the reinforcing effects of ethanol are partially mediated by nicotinic receptors , which modulate neurotransmitter release .", "it was demonstrated that the application of a cholinesterase inhibitor reduces alcohol consumption in alcohol-preferring rats .", "this suggests that galantamine ( gal ) , a cholinesterase inhibitor , could be effective when seeking to prolong abstinence in recently detoxified alcoholics .", "this study represents the first reported clinical trial of a cholinergic drug in alcohol-relapse prevention .", "we investigated the efficacy and safety of gal by conducting a @-week randomized , placebo-controlled , multicentric clinical trial on @ recently detoxified alcoholics .", "survival analyses ( kaplan-meier ) were performed to reveal evidence of prolonged abstinence periods in patients who received gal .", "our findings did not support our hypothesis .", "gal did not extend the time to first severe relapse .", "however , additional post hoc analyses suggest that relapsed patients treated with gal consume less ethanol per drinking day than patients treated with placebo .", "gal seems to be ineffective when used in relapse prevention of detoxified alcoholics .", "it is possible that alcohol needs to be `` on board '' for gal to be beneficial .", "this could explain why our post hoc analysis showed that gal possibly reduces the alcohol consumption of relapsers .", "if confirmed , gal could play a role in the reduction of harmful alcohol use and at-risk consumption ." ]

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

[ "to describe and to determine the robustness of our study evaluating the efficacy of ok-@ ( picibanil ) as a therapeutic modality for lymphangiomas .", "prospective , randomized trial and parallel-case series at @ us tertiary care referral centers .", "thirty patients diagnosed as having lymphangioma .", "ages in @ ranged from @ months to @ years .", "twenty-nine had lesions located in the head-and-neck area .", "every patient received a @-dose injection series of ok-@ scheduled @ to @ weeks apart unless a contraindication existed or a complete response was observed before completion of all injections .", "a control group was observed for @ months .", "successful outcome of therapy was defined as a complete or a substantial ( > @ % ) reduction in lymphangioma size as determined by calculated lesion volumes on computed tomographic or magnetic resonance imaging scans .", "overall , @ ( @ % ) of the @ patients with predominantly macrocystic lymphangiomas had a successful outcome .", "ok-@ should be efficacious in the treatment of lymphangiomas .", "our study design is well structured to clearly define the role of this treatment agent ." ]

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

[ "the objective of this study is to compare personalized antiplatelet therapy according to cyp@c@ phenotype with conventional antiplatelet therapy in patients after percutaneous coronary intervention ( pci ) .", "a total of @ patients with coronary artery disease ( cad ) undergoing pci randomly received a personalized antiplatelet therapy ( group a ; n = @ ) or conventional antiplatelet treatment ( group b ; n = @ ) .", "for group a , antiplatelet therapy was performed according to cyp@c@ phenotype .", "for group b , the patients received conventional antiplatelet treatment without detected cyp@c@ genotype .", "the primary end point was compared between these two groups .", "this study is registered with the chinese clinical trial registry ( chictr-trc-@ ) .", "the primary end point occurred in @ patients assigned to conventional treatment as compared with @ patients assigned to personalized therapy ( cumulative event rate , @ % vs. @ % ; p < @ ) .", "the composite rate of death , myocardial infarction , or stroke at @ days occurred in @ and @ patients in the two groups , respectively ( cumulative event rate , @ % and @ % , p < @ ) .", "the cumulative @-day incidence of st was significantly lower in group a than in group b ( @ % vs. @ % , p = @ ) .", "the @-day incidence of mi ( @ % vs. @ % , p = @ ) and death ( @ % vs. @ % , p = @ ) was fewer than that in control , respectively .", "we did not find the significant difference in bleeding events between the @ groups .", "personalized antiplatelet therapy according to cyp@c@ genotype after pci can significantly decrease the incidence of major adverse cardiovascular events and the risk of @-day st in chinese population ." ]

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

[ "the rate of adherence to regular colonoscopy screening in individuals at increased familial risk of colorectal cancer ( crc ) is suboptimal , especially among rural and other geographically underserved populations .", "remote interventions may overcome geographic and system-level barriers .", "we compared the efficacy of a telehealth-based personalized risk assessment and communication intervention with a mailed educational brochure for improving colonoscopy screening among at-risk relatives of patients with crc .", "eligible individuals age @ to @ years who were not up-to-date with risk-appropriate screening and were not candidates for genetic testing were recruited after contacting patients with crc or their next of kin in five states .", "enrollees were randomly assigned as family units to either an active , personalized intervention that incorporated evidence-based risk communication and behavior change techniques , or a mailed educational brochure .", "the primary outcome was medically verified colonoscopy within @ months of the intervention .", "of the @ eligible and randomly assigned at-risk relatives , @ % completed the outcome assessments within @ months ; @ % of those in the personalized intervention group and @ % of those in the comparison group obtained a colonoscopy .", "in an intent-to-treat analysis , the telehealth group was almost three times as likely to get screened as the low-intensity comparison group ( odds ratio , @ ; @ % ci , @ to @ ; p < @ ) .", "persons residing in rural areas and those with lower incomes benefitted at the same level as did urban residents .", "remote personalized interventions that consider family history and incorporate evidence-based risk communication and behavior change strategies may promote risk-appropriate screening in close relatives of patients with crc ." ]

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

[ "alcoholic hepatitis is a clinical syndrome characterized by jaundice and liver impairment that occurs in patients with a history of heavy and prolonged alcohol use .", "the short-term mortality among patients with severe disease exceeds @ % .", "prednisolone and pentoxifylline are both recommended for the treatment of severe alcoholic hepatitis , but uncertainty about their benefit persists .", "we conducted a multicenter , double-blind , randomized trial with a @-by-@ factorial design to evaluate the effect of treatment with prednisolone or pentoxifylline .", "the primary end point was mortality at @ days .", "secondary end points included death or liver transplantation at @ days and at @ year .", "patients with a clinical diagnosis of alcoholic hepatitis and severe disease were randomly assigned to one of four groups : a group that received a pentoxifylline-matched placebo and a prednisolone-matched placebo , a group that received prednisolone and a pentoxifylline-matched placebo , a group that received pentoxifylline and a prednisolone-matched placebo , or a group that received both prednisolone and pentoxifylline .", "a total of @ patients underwent randomization , and data from @ were available for the primary end-point analysis .", "mortality at @ days was @ % ( @ of @ patients ) in the placebo-placebo group , @ % ( @ of @ patients ) in the prednisolone-placebo group , @ % ( @ of @ patients ) in the pentoxifylline-placebo group , and @ % ( @ of @ patients ) in the prednisolone-pentoxifylline group .", "the odds ratio for @-day mortality with pentoxifylline was @ ( @ % confidence interval [ ci ] , @ to @ ; p = @ ) , and that with prednisolone was @ ( @ % ci , @ to @ ; p = @ ) .", "at @ days and at @ year , there were no significant between-group differences .", "serious infections occurred in @ % of the patients treated with prednisolone versus @ % of those who did not receive prednisolone ( p = @ ) .", "pentoxifylline did not improve survival in patients with alcoholic hepatitis .", "prednisolone was associated with a reduction in @-day mortality that did not reach significance and with no improvement in outcomes at @ days or @ year .", "( funded by the national institute for health research health technology assessment program ; stopah eudract number , @-@-@ , and current controlled trials number , isrctn@ ) ." ]

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

[ "chronic allograft nephropathy ( can ) represents the most common cause of late graft loss .", "nephrotoxicity from chronic use of calcineurin inhibitors ( cni ) has the potential to contribute to can .", "the present investigation aimed to evaluate the impact of early cni withdrawal on kidney graft function and structure at @ year in sirolimus ( srl ) - treated patients .", "forty consecutive kidney transplant recipients were initially treated with corticosteroids , cyclosporine a ( csa ) , and srl ( @ mg/day ) .", "after @ months , patients were randomly assigned to either continue the same treatment ( group i ) or to withdraw csa and continue srl ( group ii ) .", "all patients underwent kidney graft biopsy immediately after graft reperfusion ( @-hr biopsy ) and @ months after engraftment .", "baseline graft biopsy showed a higher degree of renal damage in group ii patients ( total score , @ + / -@ vs. @ + / -@ ; p < @ ) .", "twelve months after engraftment , can was diagnosed in @ % of all patients , of whom @ % were in group i and @ % in group ii .", "can lesions were scored as moderate to severe in @ % of group i patients but only @ % of group ii patients ( p < @ ) .", "a vascular score greater than or equal to @ occurred in @ % of group i patients and in @ % of group ii patients ( p < @ ) .", "at @ year , group i patients showed a significantly worse kidney graft function ( serum creatinine , @ + / -@ vs. @ + / -@ mg/dl ; creatinine clearance , @ + / -@ vs. @ + / -@ ml/min ; both p < @ ) .", "these results suggest that early withdrawal of csa is a safe option , which allows a significant reduction of chronic histologic damage , particularly vascular injury , of cadaveric kidney allografts ." ]

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

[ "current treatment of ulcerative colitis is imperfect .", "trefoil peptides are known to stimulate repair in many models of injury , including animal models of colitis .", "to assess the efficacy of trefoil factor family-@ enema treatment in a clinical trial .", "a total of @ patients with mild-to-moderate left sided ulcerative colitis were recruited into a double-blind randomized placebo-controlled study .", "patients taking steroids or with proctitis only were excluded .", "patients received @ ml enemas containing either human recombinant trefoil factor family-@ ( @ mg/ml ) or saline alone once a day for @ days .", "all patients also received an oral dose-increment of @ g of mesalazine daily above their normal usage .", "patients were assessed at @ , @ , @ and @ weeks .", "remission was defined as ulcerative colitis disease activity index of @ or @ with no blood in stool .", "individual clinical improvement was defined as a ulcerative colitis disease activity index reduction of > @ .", "data was analysed using chi-square test and anova .", "median ulcerative colitis disease activity index at entry were @ ( trefoil factor family-@ group ) and @ ( placebo group ) .", "analysed on an intention-to-treat basis , only one patient went into remission ( in trefoil factor family-@ group at day @ ) .", "clinical improvement was seen in two trefoil factor family-@ and three placebo patients on day @ and two patients in each group on day @ .", "increasing the dose of @-aminosalicylic acid was moderately effective in reducing the ulcerative colitis disease activity index but was insufficient to induce remission .", "trefoil factor family-@ enemas were well-tolerated but did not provide additional benefit above that of adding additional @-aminosalicylic acid alone ." ]

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

[ "to compare failure-free survival ( ffs ) and survival for patients with local or regional embryonal rhabdomyosarcoma treated on the intergroup rhabdomyosarcoma study ( irs ) - iv with that of comparable patients treated on irs-iii .", "patients were retrospectively classified as low - or intermediate-risk .", "low-risk patients were defined as those with primary tumors at favorable sites , completely resected or microscopic residual , or orbit/eyelid primaries with gross residual disease and tumors less than @ cm at unfavorable sites but completely resected .", "intermediate-risk patients were all other patients with local or regional tumors .", "three-year ffs improved from @ % on irs-iii to @ % on irs-iv for patients with intermediate-risk embryonal rhabdomyosarcoma ( p = @ ) .", "subset analysis revealed two groups that benefited most from irs-iv therapy .", "ffs at @ years for patients with resectable node-positive or unresectable ( group iii ) embryonal rhabdomyosarcoma arising at certain favorable sites ( head and neck [ not orbit/eyelid or parameningeal ] and genitourinary [ not bladder or prostate ] ) improved from @ % on irs-iii to @ % on irs-iv ( p = @ ) .", "similarly , @-year ffs for patients with completely resected tumor or with only microscopic disease remaining ( group i or ii ) at unfavorable sites improved from @ % on irs-iii to @ % on irs-iv ( p = @ ) .", "only patients with unresectable embryonal rhabdomyosarcoma ( group iii ) at unfavorable sites had no improvement in outcome on irs-iv ( @-year ffs for irs-iii and irs-iv , @ % and @ % , respectively ; p = @ ) .", "irs-iv therapy benefited certain subgroups of patients with intermediate-risk embryonal rhabdomyosarcoma .", "a doubling of the intensity of cyclophosphamide ( or ifosfamide equivalent ) dosing per cycle between irs-iii and irs-iv is thought to be a key contributing factor for this improvement ." ]

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

[ "to evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens ( iol ) using a custom-developed software for analysis of slit-lamp photographs .", "in a prospective , multicenter study , @ eyes were implanted with the tecnis toric iol ( abbott medical optics , inc. , santa ana , ca ) .", "a custom-developed software was used to analyze high-resolution slit-lamp photographs of @ eyes taken at day @ ( baseline ) and @ , @ , and @ months postoperatively .", "the software uses iris and sclera landmarks to align the baseline image and later images for comparison .", "validation of software was performed through repeated analyses of protractor images rotated from @ to @ and randomly selected photographs of @ eyes .", "software validation showed precision ( repeatability plus reproducibility variation ) of @ using protractor images and @ using slit-lamp photographs .", "good quality slit-lamp images and clear landmarks were necessary for precise measurements .", "at @ months , @ % of eyes had @ or less change in iol orientation versus baseline ; only @ eyes ( @ % ) had axis shift greater than @ .", "most eyes were within @ or less of rotation between @ and @ months ( @ % ) and @ and @ months ( @ % ) .", "mean absolute axis change ( standard deviation ) from @ day to @ months was @ @ .", "the new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric iol rotation ." ]

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

[ "to determine whether supplementation with vitamin d improves resilience to the adverse effects of earthquakes .", "opportunistic addition to an established randomised double blind placebo controlled trial .", "christchurch , new zealand , where a prolonged series of catastrophic earthquakes beginning on @ september @ occurred , which caused widespread destruction , fatalities , and extensive psychological damage .", "@ healthy adults ( @ women ; @ men ) aged @-@ who were already participating in the vitamin d and acute respiratory infections study ( vidaris ) between february @ and november @ .", "participants were randomised to receive an oral dose of either @,@ iu vitamin d@ monthly for two months then @,@ iu monthly ( n = @ ) or placebo ( n = @ ) for a total of @ months .", "this is a post hoc analysis from the previously published vidaris trial .", "the primary endpoint in the current analysis was the self reported effects and overall adverse impact of the christchurch earthquakes as assessed by questionnaire four months after the most destructive earthquake on @ february @ , which was used as the index event .", "the secondary end point was the number of `` psychological '' adverse events that participants reported at their usual monthly appointments as part of the original vidaris trial .", "@ participants completed the earthquake impact questionnaire ( n = @ in the vitamin d group and @ in the placebo group ) .", "there was no significant difference in the number of self reported adverse effects between those receiving vitamin d supplementation and those receiving placebo .", "there was also no difference in the overall adverse impact score between treatment groups ( ( @ ) p = @ ) .", "the exception was that those in the vitamin d group experienced more adverse effects on family relationships ( @ % v @ % ; ( @ ) p = @ ) .", "the number of psychological adverse events-such as fatigue , stress , anxiety , and insomnia-that participants reported at their usual monthly appointments was significantly higher after the earthquake ( ( @ ) p = @ ) but did not differ between treatment groups .", "in this trial , vitamin d supplementation did not reduce the adverse impact of earthquakes in healthy adults .", "trial registration australian new zealand clinical trials registry ( anzctr.org.au ) actrn@ ." ]

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

[ "to determine the effectiveness of treatment of lactating cows with high somatic cell counts in milk .", "randomised clinical trial .", "single pooled quarter samples of milk were obtained from cows with somatic cell counts above @,@ cells/ml on fifty farms .", "milk samples were cultured for known mastitis bacterial pathogens .", "cows were randomly allocated to treated and untreated groups .", "treated cows received both intramammary cloxacillin and parenteral erythromycin .", "single pooled quarter milk samples were obtained at @ weeks after treatment and were cultured for the presence of pathogenic bacteria .", "the percentage of samples with no growth at the post-treatment culture was used as an estimate of the bacteriological cures for each pathogen type and for each treatment group .", "somatic cell counts of cows were compared between treatment groups and within pathogen group .", "the number of cows that completed a full lactation were compared between each treatment group and within each pathogen group .", "treatment had no effect upon bacteriological cures , irrespective of pathogen present or the presence of bacteria during the previous lactation .", "there was no effect of treatment upon somatic cell count except for cows infected with streptococcus dysgalactiae in which treatment caused a significant lowering of cell counts .", "this effect was not present in the subsequent lactation .", "treatment of chronically infected cows did not alter the probability of a cow completing a full lactation but did improve the probability of newly infected cows being retained for the next lactation .", "twenty-eight of @ treated cows developed clinical mastitis in more than one quarter after treatment , thus indicating a poor technique by farmers for the insertion of intramammary antibiotics .", "treatment during lactation of cows with high somatic cell counts in milk is ineffective in reducing bacterial infections and in reducing somatic cell counts to acceptable numbers ." ]

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

[ "to develop responder definitions for fibromyalgia ( fm ) clinical trials using key symptom and function domains .", "twenty-four candidate responder definitions were developed by expert consensus and were evaluated in @ randomized , placebo-controlled trials of @ medications for the treatment of fm .", "for each definition , the treatment effects of the medication compared with placebo were analyzed using cochran-mantel-haenszel tests or chi-square tests .", "a meta-analysis of the pooled results for the @ medications established risk ratios to determine the definitions that best favored medication over placebo .", "two definitions performed best in the analyses .", "both definitions included @ % reduction in pain and @ % improvement in physical function .", "the definitions differed in that one ( @ % improvement in fm [ fm@ ] short version ) included @ % improvement in sleep or fatigue , and the other ( fm@ long version ) required @ % improvement in @ of the following symptoms : sleep , fatigue , depression , anxiety , or cognition .", "in the analysis of both versions , the response rate was @ % for each medication and was significantly greater compared with placebo .", "the risk ratio favoring drug over placebo in the pooled analysis for fm@ version @ ( short version ) was @ ( @ % confidence interval [ @ % ci ] @-@ @ ; p @ ) ; the risk ratio for fm@ version @ ( long version ) was @ ( @ % ci @-@ @ ; p @ ) .", "among the @ responder definitions tested , @ were identified as most sensitive in identifying response to treatment .", "the identification of responder definitions for fm clinical trials that include assessments of key symptom and function domains may improve the sensitivity of clinical trials to identify meaningful improvements , leading to improved management of fm ." ]

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

[ "to determine the effectiveness of a counseling and support intervention for spouse caregivers in delaying time to nursing home placement of patients with alzheimer disease ( ad ) , and identify the mechanisms through which the intervention accomplished this goal .", "we conducted a randomized controlled trial of an enhanced counseling and support intervention compared to usual care .", "participants were a referred volunteer sample of @ spouse caregivers of community-dwelling patients who had enrolled in the study over a @-year period .", "the intervention consisted of six sessions of individual and family counseling , support group participation , and continuous availability of ad hoc telephone counseling .", "structured questionnaires were administered at baseline and at regular follow-up intervals , every @ months for the first year and every @ months thereafter .", "cox proportional hazard models were used to test the effects of the intervention on the time to nursing home placement for the patients after controlling for multiple time-invariant and time-dependent predictors of placement .", "patients whose spouses received the intervention experienced a @ % reduction in the rate of nursing home placement compared with usual care controls ( hazard ratio = @ after covariate adjustment , p = @ ) .", "the difference in model-predicted median time to placement was @ days .", "improvements in caregivers ' satisfaction with social support , response to patient behavior problems , and symptoms of depression collectively accounted for @ % of the intervention 's beneficial impact on placement .", "greater access to effective programs of counseling and support could yield considerable benefits for caregivers , patients with alzheimer disease , and society ." ]

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

[ "to evaluate the effect of periprostatic infiltration with local anesthesia on the level of discomfort associated with transrectal ultrasound-guided needle biopsy of the prostate .", "transrectal ultrasound-guided needle biopsy of the prostate is the standard procedure to diagnose prostate cancer .", "a prospective , randomized , double-blind study was performed on @ men referred for biopsy of the prostate .", "fifty subjects were randomized to periprostatic injection of @ ml of @ % lidocaine solution without epinephrine , and @ were randomized to injection of placebo ( @ ml of @ % nacl ) .", "each subject completed three @-point visual analog scales for pain after a series of @ needle biopsies .", "pain was rated during the biopsy , diagnostic investigation , and injection of lidocaine .", "patients who received local anesthesia had significantly lower visual analog scale scores compared with the group without lidocaine during the biopsy ( mean score @ versus @ , p < @ ) and diagnostic examination ( mean score @ versus @ , p = @ ) .", "lidocaine injection caused no adverse effects .", "periprostatic injection of lidocaine represents a simple and safe procedure that significantly reduces discomfort during probe manipulation and biopsy .", "we recommend this procedure in men undergoing transrectal ultrasound-guided prostate biopsy ." ]

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

[ "to determine which diary card variables are the most predictive for administration of additional courses of corticosteroids using the trust ( the regular use of salbutamol trial ) data set .", "logistic regression models were used to identify the extent to which a change in diary card variable affected the odds ratio ( or ) for administering a course of oral or increased inhaled corticosteroids .", "the complete trust diary card data were used with over @,@ days of diary card observations from @ mild to moderate asthmatic subjects .", "an increase in daytime symptoms of @-@ u over baseline was associated with an increase in the or for starting all types of corticosteroids from two - to @-fold .", "these results indicate that an increase in daytime symptoms of two or more over baseline strongly predicts the administration of additional corticosteroids .", "the results have significant implications for both clinical practice and design of clinical trials in asthma ." ]

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

[ "to determine whether cisapride is effective in the treatment of children with constipation .", "double-blind , placebo-controlled study in which children with chronic constipation were randomly assigned to treatment with cisapride or placebo for @ weeks .", "forty children were enrolled , and @ completed the therapy .", "treatment successes occurred in @ of @ ( @ % ) subjects in the cisapride group and @ of @ ( @ % ) subjects in the placebo group ( p < @ ) .", "the odds ratio for response after cisapride administration was @ times higher ( @ % ci @ to @ ) .", "during cisapride therapy , there was a significant improvement in number of spontaneous bowel movements per week ( from @ + / - @ to @ + / - @ ) , and there was a significant decrease in number of fecal soiling episodes per day ( @ + / - @ to @ + / - @ ) , percent with encopresis ( @ % vs @ % ) , number of laxative doses per week ( from @ + / - @ to @ + / - @ ) , percent using laxatives ( @ % to @ % ) , and total gastrointestinal transit time ( from @ + / - @ hours to @ + / - @ hours ) .", "with placebo , there were no significant changes in the number of spontaneous bowel movements ( from @ + / - @ to @ + / - @ ) , percent with encopresis ( @ % vs @ % ) , or total gastrointestinal transit time ( from @ + / - @ hours to @ + / - @ hours ) ; but there was a significant decrease in number of fecal soiling episodes per day ( from @ + / - @ to @ + / - @ ) and number of laxative doses used per week ( from @ + / - @ to @ + / - @ ) .", "the final number of spontaneous bowel movements , fecal soiling episodes , laxatives used , or percent patients with encopresis was not different when patients receiving cisapride were compared with those receiving placebo .", "cisapride was effective in the treatment of children with constipation ." ]

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

[ "associations between hla-dr genotypes and susceptibility to crohn 's disease ( cd ) have been reported .", "however , it is not known whether certain hla-dr genotypes or il-@ra gene polymorphism are associated with responsiveness to treatment or different clinical patterns of disease .", "in a large , randomized , controlled multicentre trial , @ patients with cd were treated with daily doses of @ , @ or @ mg budesonide .", "patients were stratified into two groups : patients without steroid pretreatment and with active cd ( cdai > @ ) and patients with conventional steroid pretreatment of < or = @ mg prednisolone per day , which was replaced by oral budesonide within @ weeks .", "the hla-drb@ genotypes @-@ and the il-@ra gene polymorphism were examined for an association with budesonide treatment failure .", "only hla-dr @ was associated with treatment failure of budesonide .", "hla-dr @ is not very common .", "only @/@ patients who could be evaluated expressed this genotype , and @ of these @ patients did not respond to budesonide ( p < @ ) .", "neither the other hla-dr genotypes nor the il-@ra gene polymorphism had an influence on treatment outcome of budesonide therapy .", "no significant association of fistulas , perianal disease , need for bowel resections , and disease localization with certain hla-drb@ genotypes or the il-@ra gene polymorphism were found .", "this is the first description of an association of a certain hla-dr genotype ( hla-dr @ ) with treatment failure in inflammatory bowel disease ( ibd ) ." ]

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

[ "the role of endothelial injury and circulating adhesion molecule in the development and progression of diabetic peripheral neuropathy in the long-term has been established previously .", "to study the effects of short-term glycemic control using insulin and oral hypoglycemic agent therapy ( oha ) on the peroneal nerve function and vascular cell adhesion molecule-@ ( vcam-@ ) and advanced glycation endproducts ( age ) levels in type @ diabetic patients .", "a randomized controlled study involving poorly controlled ( hba@c , @ % -@ % ) type @ diabetic patients attending the endocrinology outpatient center in a tertiary hospital in kuala lumpur .", "twenty-nine patients were randomized to receive insulin ( n = @ ) or oha ( n = @ ) for @ weeks .", "the glycemic variables ( hba@c , fasting plasma glucose [ fpg ] , fructosamine ) , vcam-@ , serum age and the peroneal motor conduction velocity ( pmcv ) were measured at baseline and at @-week intervals .", "paired ` t ' test or kruskal wallis test ; and the unpaired ` t ' test or mann-whitney u test were used for within-group and between-group analyses , respectively .", "correlation was analyzed using spearman 's correlation coefficient .", "within-group analysis showed significant progressive improvement in hba@c at weeks @ and @ in the insulin group .", "the pmcv improved significantly in both groups by week @ , and by week @ ( p = @ ) in the insulin group .", "pmcv correlated negatively with vcam-@ ( p = @ ) and age ( p = @ ) at week @ .", "aggressive glycemic control with insulin improves the peroneal nerve function within @ weeks .", "improvement in the serum vcam-@ and age levels correlated significantly with improvement in peroneal nerve conduction velocity only in the insulin group ." ]

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

[ "despite growing evidence that the marital problems typically attributed to heavy drinking are stronger for couples in which only one partner is a heavy drinker than in couples in which both partners are heavy drinkers , relatively little research has examined factors that may serve to maintain particular drinking configurations .", "the current research examines the association between the configuration of partners ' drinking and relationship-specific alcohol expectancies .", "data are from an ongoing prospective study examining the effect of alcohol on executive cognitive functioning .", "participant couples ( n = @ ) represented one of four drinking groups : concordant heavy drinkers ( n = @ ) , heavy drinking husband ( n = @ ) , heavy drinking wife ( n = @ ) , and concordant abstainers/light drinkers ( n = @ ) .", "as part of the study , participant couples completed a measure of relationship-specific alcohol expectancies through the mail .", "analyses reveal that wives demonstrate greater intimacy/openness expectancies in the concordant heavy drinking group than in the other three groups , as predicted .", "unexpectedly , husbands demonstrate greater intimacy/openness expectancies if either member of the couple is a heavy drinker .", "additionally , couples reported stronger sexual enhancement , power/assertion , and social pleasure/fun expectancies when the wife was a heavy drinker and stronger power/assertion expectancies when the husband was a heavy drinker .", "relationship-specific alcohol expectancies are differentially associated with the configuration of partners ' drinking patterns .", "wives ' drinking status appears to influence relationship-specific alcohol expectancies to a greater extent than husbands ' drinking status .", "additional research is needed to determine the long-term effect of these associations ." ]

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

[ "the purpose of this study was to compare defect extent and severity and myocardial uptake with exercise and pharmacologic stress with technetium-@m ( tc-@m ) tetrofosmin tomographic myocardial perfusion imaging .", "detection of stress-induced myocardial perfusion defects depends on both a disparity in blood flow between normal and stenotic vessels and the extraction fraction and linearity of myocardial uptake of the tracer .", "there are limited clinical data for exercise or pharmacologic stress with tc-@m tetrofosmin tomographic myocardial perfusion imaging .", "thirty-one patients with coronary artery disease and @ with a < @ % likelihood of coronary artery disease underwent on separate days tc-@m tetrofosmin single-photon emission computed tomographic imaging at rest and after exercise , dipyridamole , adenosine , and dobutamine stress .", "images were interpreted by a blinded consensus of @ experienced readers with a @-segment model and @-point scoring system .", "compared with exercise , the summed stress score was smaller with dipyridamole ( p < @ ) , and the reversibility score was smaller with both dipyridamole ( p < @ ) and dobutamine ( p < @ ) , whereas the number of abnormal and reversible segments was less with both dipyridamole ( p < @ and p < @ , respectively ) and dobutamine ( both p < @ ) .", "no significant differences were found in the summed stress or reversibility scores and the number of abnormal or reversible segments between exercise and adenosine .", "compared with exercise , defect extent , severity , and reversibility are less with dipyridamole and dobutamine with tc-@m tetrofosmin single photon emission computed tomographic imaging ." ]

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

[ "to evaluate the validity of parents ' self reported home safety practices concerning smoke detectors , bike helmets , car seats , and water heater temperature .", "parents of children @ years old and under whose child had made at least one visit to a study clinic in the years @-@ .", "as part of a randomized controlled trial to improve patient provider communication and preventive practices , parents ' responses to telephone interview were compared with observations of safety practices during a home visit .", "home visits were completed within nine weeks of the telephone interview .", "parents were not told that the visit was part of a validation study and home visit observers were unaware of the interview responses .", "the authors calculated sensitivities , specificities , positive and negative predictive values , and their corresponding confidence intervals .", "sensitivity ( @ to @ ) and positive predictive values ( @ to @ ) were high for all items .", "specificities and negative predictive values were more variable and the highest estimates ( specificity @ to @ , negative predictive value @ to @ ) were for car seat types .", "the results suggest that parent self report practice of certain injury prevention behaviors ( owning a car seat , hot water temperatures ) is reliable , whereas self reports on other practices ( working smoke detectors , properly fitting bike helmets ) may be overstated ." ]

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

[ "to examine the long-term safety and efficacy of three antipsychotics in early-onset schizophrenia spectrum disorders .", "patients ( @ to @ years old ) who had improved during an @-week , randomized , double-blind acute trial of olanzapine , risperidone , or molindone ( plus benztropine ) were eligible to continue on the same medication for up to @ additional weeks under double-blind conditions .", "adjunctive medications were allowed according to defined algorithms .", "standardized symptom , safety , and functional assessments were conducted every @ weeks .", "of the @ youths randomized in the acute trial , @ entered maintenance treatment ( molindone , n = @ ; olanzapine , n = @ ; risperidone , n = @ ) .", "fourteen ( @ % ) completed @ weeks of treatment .", "adverse effects ( n = @ ) , inadequate efficacy ( n = @ ) , or study nonadherence ( n = @ ) were the most common reasons for discontinuation .", "the three treatment arms did not significantly differ in symptom decrease or time to discontinuation .", "akathisia was more common with molindone and elevated prolactin concentrations more common with risperidone .", "although weight gain and metabolic adverse events had occurred more often with olanzapine and risperidone during the acute trial , no significant between-drug differences emerged in most of these parameters during maintenance treatment .", "only @ % of youths with early-onset schizophrenia spectrum disorders continued on their originally randomized treatment at @ weeks .", "no agent demonstrated superior efficacy , and all were associated with side effects , including weight gain .", "improved treatments are needed for early-onset schizophrenia spectrum disorders .", "clinical trial registry information-treatment of schizophrenia and related disorders in children and adolescents ; url : http://www.clinicaltrials.gov , unique identifier : nct@ ." ]

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

[ "to confirm the recurrence-preventing efficacy and safety of @-month bacillus calmette-gurin ( bcg ) maintenance therapy for non-muscle-invasive bladder cancer .", "the enrolled patients had been diagnosed with recurrent or multiple non-muscle-invasive bladder cancer ( stage ta or t@ ) after complete transurethral resection of bladder tumours ( turbt ) .", "the patients were randomized into three treatment groups : a maintenance group ( bcg , @ mg , intravesically instilled once weekly for @ weeks as induction therapy , followed by three once-weekly instillations at @ , @ , @ and @ months after initiation of the induction therapy ) , a non-maintenance group ( bcg , @ mg , intravesically instilled once weekly for @ weeks ) and an epirubicin group ( epirubicin , @ mg , intravesically instilled nine times ) .", "the primary endpoint was recurrence-free survival ( rfs ) .", "efficacy analysis was performed for @ of the full-analysis-set population of @ eligible patients , including @ maintenance group patients , @ non-maintenance group patients and @ epirubicin group patients .", "at the @-year median point of the overall actual follow-up period , the final cumulative rfs rates in the maintenance , non-maintenance and epirubicin groups were @ % , @ % and @ % , respectively .", "the rfs following turbt was significantly prolonged in the maintenance group compared with the non-maintenance group ( generalized wilcoxon test , p = @ ) .", "bcg maintenance therapy significantly prolonged the post-turbt rfs compared with bcg induction therapy alone or epirubicin intravesical therapy ." ]

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

[ "pilsicainide is a newly synthesized antiarrhythmic agent with class ic properties .", "various antiarrhythmic agents have been used to convert atrial fibrillation ( af ) to sinus rhythm or decrease the rate of relapse of af .", "we randomly assigned @ patients with chronic af to oral treatment of either a placebo ( @ patients ) or @ mg/day of pilsicainide ( @ patients ) for @ weeks before electrical cardioversion .", "before oral administration of pilsicainide , @ patients underwent transesophageal echocardiography to investigate whether there was thrombus formation in the heart chambers .", "patients without pharmacologic defibrillation underwent direct current cardioversion to restore sinus rhythm .", "after successful cardioversion , all patients continued to receive pilsicainide and were monitored for up to @ years .", "before cardioversion , @ patients in the pilsicainide group ( @ % ) reverted to sinus rhythm .", "no patients in the placebo group reverted to sinus rhythm .", "direct current cardioversion was performed in @ patients ; however , @ patients were not converted to sinus rhythm ( @ patients receiving pilsicainide , @ patients receiving placebo ) , and @ patients needed intracardiac cardioversion to convert to sinus rhythm .", "asymptomatic bradyarrhythmias were observed in @ patients in the pilsicainide group .", "during the follow-up period , @ patients ( @ % ) in the pilsicainide group remained in sinus rhythm at @ month ; this number decreased to @ patients ( @ % ) at @ months , @ ( @ % ) at @ months , @ ( @ % ) at @ months , @ ( @ % ) at @ months , and @ ( @ % ) at @ months .", "all patients receiving placebo continued to receive placebo after the cardioversion , and af recurred a few days after cardioversion in all cases .", "no independent discriminant variables were identified in the groups between maintenance and nonmaintenance of sinus rhythm .", "although no serious side effects regarding pilsicainide have been documented , one patient died of acute myocardial infarction , most likely not related to pilsicainide administration .", "pilsicainide is effective in restoring or maintaining sinus rhythm in patients with chronic af lasting longer than an average duration of @ months .", "no major adverse effects were observed ." ]

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

[ "to determine the effect of high dose ipratropium bromide , both alone or in combination with standard dose salbutamol , on pulmonary function in patients presenting to the emergency department ( ed ) with acute exacerbation of chronic obstructive airways disease ( coad ) .", "the trial was a prospective , randomised , double blind trial of adult patients with coad .", "all patients received nebulised salbutamol @ mg and @ microg ipratropium and hydrocortisone @ mg i.v. at time = @ , then were randomised to receive further nebulisers at time = @ minutes and time = @ minutes of salbutamol @ mg combined with ipratropium @ microg or salbutamol @ mg alone or ipratropium @ microg alone .", "pulmonary function tests were conducted at time = @ and time = @ minutes .", "the primary endpoints were absolute and percent change in fev@ .", "the group randomised to receive @ mg salbutamol and @ microg ipratropium ( n = @ ) showed a mean percentage change of fev@ of @ % with a mean absolute change of @ l ( sd @ l ) .", "those who received @ mg salbutamol ( n = @ ) had a mean percentage change of @ % with a mean absolute change of @ l ( sd of @ l ) .", "those who received @ microg ipratropium ( n = @ ) had a mean percentage change of @ % with a mean absolute change of @ l ( sd of @ l ) .", "there was no significant difference between the groups in fev@ ( p = @ for percentage change ; p = @ for absolute change ) .", "the addition of @ microg ipratropium to @ mg salbutamol in subsequent nebulisers adds no benefit to pulmonary function after the initial nebuliser of both bronchodilators in the treatment of coad in the ed ." ]

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

[ "combined spinal-epidural anesthesia ( cse ) may offer theoretic advantages for outpatient surgery , because it produces the rapid onset of spinal anesthesia , with the option to extend the blockade with an epidural catheter .", "in this study , the authors attempted to determine an appropriate initial dose of a short-acting local anesthetic , @ % lidocaine , to administer for outpatient knee arthroscopy using cse .", "data were collected from @ patients undergoing outpatient knee arthroscopy .", "using a double-blinded , prospective study design , patients were randomly assigned to receive cse with an initial dose of intrathecal @ % lidocaine of @ , @ , or @ mg .", "a @-g @ @/@ - inch whitacre needle was placed through a @-g weiss needle .", "onset and regression of sensory anesthesia and motor blockade were measured by a blinded observer at frequent intervals .", "all @ patients had adequate anesthesia .", "durations of thoracic and lumbar sensory and lower limb motor blockade were significantly shorter in the @-mg group compared with the @ - or @-mg groups ( p < @ mantel-cox , survivorship analysis ) .", "indices of neural blockade resolved @-@ min more rapidly in the @-mg group than in either the @ - or @-mg group .", "times to urinate , site upright in a chair , take oral fluids , and be discharged were all significantly shorter ( between @ and @ min ) in the @-mg group compared with the @ - and @-mg groups ( p < @ ) .", "seven patients required intraoperative epidural supplementation : three in the @-mg group , three in the @-mg group , and one in the @-mg group .", "combined spinal-epidural anesthesia with a @-mg initial intrathecal dose of lidocaine provided reliable anesthesia for knee arthroscopy .", "duration of spinal anesthesia with lidocaine was dose related ." ]

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

[ "to assess the impact of instructional guidance in the regular use of use nicotine nasal spray ( nns ) on the true use of nns during the first three weeks of smoking cessation for heavy smokers who are willing to quit .", "this randomized , open , controlled trial included @ patients who were heavy smokers , were willing to quit , and attending an academic outpatient clinic in western switzerland .", "patients were randomised to instruction on nns use as `` ad libitum '' ( administration whenever cravings appear ; control group ) or to use nns when craving appears and at least every hour when awake ( intervention group ) .", "intakes were monitored using an electronic device fixed in the spray unit ( mdilog ) during the first three weeks of use .", "self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide .", "using intention-to-treat analysis , random-effect gls regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual .", "one patient was lost to follow-up .", "at baseline randomization , the group receiving instruction to use nns hourly included more women , patients with previous desires to quit , and patients with more psychiatric comorbidities and less somatic complaints compared to the group instructed to use nns with cravings ( group imbalance ) .", "both groups self-administered more than the daily recommended dosage of @ uses .", "mean daily usage was @ dose/day and @ dose/day for the group instructed to use nns hourly and with cravings , respectively .", "adjusting for baseline imbalance , the increased daily doses in the intervention group ( hourly use ) remained nonsignificant compared to ad libitum use ( -@ dose/day ; ci @ % -@ ; @ , from day @ to day @ ; and @ dose/day ; ci @ % -@ ; @ , from day @ to day @ ) .", "instructing patients to use the nns daily had no effect on smoking cessation at six months ( rr = @ ; ci @ % @ ; @ ) .", "heavy smokers willing to quit use nns frequently , regardless of the instructions given .", "recommending the use of nns only when craving appears for heavy smokers willing to quit seems acceptable compared to prescribing hourly administration .", "clinicaltrials.gov : nct@ ." ]

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

[ "prior analysis in the open vs endovascular repair veterans affairs ( va ) cooperative study ( csp # @ ) demonstrated that survival , quality of life , and total health care costs are not significantly different between the open and endovascular methods of repair of abdominal aortic aneurysm .", "the device is a major cost of this method of repair , and the objective of this study was to evaluate the costs of the device , abdominal aortic aneurysm repair , and total health care costs when different endograft systems are selected for the endovascular repair ( evr ) .", "within each selected system , evr costs are compared with open repair costs .", "the study randomized @ patients to open ( n = @ ) or evr ( n = @ ) .", "device selection was recorded before randomization ; therefore , open repair controls were matched to each device cohort .", "data were excluded for two low-volume devices , implanted in only @ individuals , leaving @ control and @ endovascular patients : @ zenith ( cook medical , bloomington , ind ) , @ excluder ( w. l. gore & associates , flagstaff , ariz ) , and @ aneurx ( medtronic , minneapolis , minn ) .", "mean device , hospitalization , and total health care costs from randomization to @ years were compared .", "health care utilization data were obtained from patients and national va and medicare data sources .", "va costs were determined using methods previously developed by the va health economics resource center .", "non-va costs were obtained from medicare claims data and billing data from the patient 's health care providers .", "implant costs were @ % of initial hospitalization costs .", "mean device ( range , $ @,@ - $ @,@ ) , initial hospitalization ( range , $ @,@ - $ @,@ ) , and total health care costs at @ years in the endovascular ( range , $ @,@ - $ @,@ ) and open repair groups ( range , $ @,@ - $ @,@ ) were not significantly different among device systems .", "differences between endovascular and corresponding open repair cohorts showed lower mean costs for evr ( range , $ @ - $ @ ) , but these were not statistically different .", "the implant costs of endovascular aneurysm repair are substantial .", "when evaluating total health care system expenditures , there is large individual variability in costs , and there is no significant difference at @ years among systems or when an individual system is compared with open repair ." ]

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

[ "to investigate the effect of medially linking knee-ankle-foot orthoses ( kafos ) on postural stability and sway during ( @ ) quiet standing and ( @ ) functional activities for persons with spinal cord injury ( sci ) .", "a randomized , mixed design , with the factors being activity ( quiet standing and two function-mimicking tasks ) , sci ( present or not ) , and type of orthosis used in sci group ( linked or unlinked kafo ) .", "nine men with t@ to t@ paraplegia , @ of whom had complete lesions and @ with some sacral sparing ( american spinal injury association grade b ) without proprioception , matched to @ able-bodied men .", "mean amplitude of sway and sway path in anteroposterior and mediolateral directions , derived from center of pressure measurements on a force platform .", "all men with sci were able to stand unsupported and perform function-mimicking activities in medially linked kafos ; however , when wearing unlinked kafos only @ could maintain balance during quiet stance and @ could maintain balance during activity .", "significant differences were found between linked and unlinked kafos ; side-to-side mean amplitude of sway was less and sway path was greater for sci subjects when they wore the linked kafos .", "medial linkage of bilateral kafos provides an effective strategy to improve stability and increase postural control for persons with sci , facilitating performance of functional activities during standing without upper limb support ." ]

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

[ "magnesium reverses cerebral vasospasm and reduces infarct volume after experimental subarachnoid hemorrhage ( sah ) in rats .", "we aimed to assess whether magnesium reduces the frequency of delayed cerebral ischemia ( dci ) in patients with aneurysmal sah .", "patients were randomized within @ days after sah .", "magnesium sulfate therapy consisted of a continuous intravenous dose of @ mmol/l per day , to be started within @ days after sah and continued until @ days after occlusion of the aneurysm .", "the primary outcome dci ( defined as the occurrence of a new hypodense lesion on computed tomography compatible with clinical features of dci ) was analyzed according to the `` on-treatment '' principle .", "for the secondary outcome measures `` poor outcome '' ( rankin > @ ) and `` excellent outcome '' ( rankin @ ) , we used the `` intention-to-treat '' principle .", "a total of @ patients were randomized .", "magnesium treatment reduced the risk of dci by @ % ( hazard ratio , @ ; @ % ci , @ to @ ) .", "after @ months , the risk reduction for poor outcome was @ % ( risk ratio , @ ; @ % ci , @ to @ ) .", "at that time , @ patients in the treatment group and @ in the placebo group had an excellent outcome ( risk ratio , @ ; @ % ci , @ to @ ) .", "this study suggests that magnesium reduces dci and subsequent poor outcome , but the results are not yet definitive .", "a next step should be a phase iii trial to confirm the beneficial effect of magnesium therapy , with poor outcome as primary outcome ." ]

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

[ "to compare clomiphene citrate ( cc ) and letrozole used for superovulation before intrauterine insemination ( iui ) in unexplained infertility .", "prospective randomized trial .", "a university teaching hospital and a private practice setting .", "four hundred and twelve infertile women with unexplained infertility .", "patients were randomized to treatment with @ mg of cc daily ( @ patients , @ cycles ) or @ mg of letrozole daily ( @ patients , @ cycles ) for @ days starting on day @ of menses .", "the iui was done @ + / - @ hours after human chorionic gonadotropin ( hcg ) injection .", "number of follicles , serum estradiol level , serum progesterone level , endometrial thickness , and pregnancy and miscarriage rates .", "the total number of follicles during stimulation was statistically significantly greater in the cc group ( @ + / - @ vs. @ + / - @ ) .", "there was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hcg administration .", "serum e ( @ ) and progesterone concentrations were statistically significantly higher in the cc group .", "the days to hcg injection were similar in both groups .", "pregnancy occurred in @ out of @ patients ( @ cycles ) in the letrozole group ( @ % and @ % , respectively ) and @ out of @ patients ( @ cycles ) ( @ % and @ % , respectively ) in the cc group ; the differences were not statistically significant .", "two twin pregnancies occurred in the cc group .", "this study found no superiority between letrozole and cc for inducing ovulation in women with unexplained infertility before iui ." ]

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

[ "despite great reduction of in-stent restenosis , first-generation drug-eluting stents ( dess ) have increased the risk of late stent thrombosis due to delayed endothelialization .", "arsenic trioxide , a natural substance that could inhibit cell proliferation and induce cell apoptosis , seems to be a promising surrogate of sirolimus to improve des performance .", "this randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent ( aes ) , compared with traditional sirolimus-eluting stent ( ses ) .", "patients with symptoms of angina pectoris were enrolled and randomized to aes or ses group .", "the primary endpoint was target vessel failure ( tvf ) , and the second endpoint includes rates of all-cause death , cardiac death or myocardial infarction , target lesion revascularization ( tlr ) by telephone visit and late luminal loss ( lll ) at @-month by angiographic follow-up .", "from july @ to @ , @ patients were enrolled and randomized @:@ to receive either aes or ses .", "at @ years of follow-up , tvf rate was similar between aes and ses group ( @ % vs. @ % , p = @ ) .", "frequency of all-cause death was significantly lower in aes group ( @ vs. @ % , p = @ ) .", "there was no significant difference between aes and ses in frequency of tlr and in-stent restenosis , but greater in-stent lll was observed for aes group ( @ @ mm vs. @ @ mm , p = @ ) .", "after @ years of follow-up , aes demonstrated comparable efficacy and safety to ses for the treatment of de novo coronary artery lesions ." ]

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

[ "although research has shown that whether people talk about health issues influences health campaign effects , no evidence exists on whether conversational valence fulfils a mediating role within health campaign effects .", "in the context of alcohol consumption , this two-wave experimental research studies the effects of exposure to an anti-alcohol message on conversational valence about alcohol .", "further , it investigates whether valence subsequently affects alcohol consumption intentions .", "eighty-four undergraduate students , in dyads , were randomly assigned to one of two conditions ( anti-alcohol message vs. no alcohol message exposure ) .", "a baseline measure of the intention to refrain from binge drinking was assessed in advance .", "two weeks later , half of the participants were exposed to an anti-alcohol message , after which all pairs engaged in a conversation about alcohol and binge drinking followed by an assessment of conversational valence and again the intention to refrain from binge drinking .", "an indirect effect of health message exposure on the intention to refrain from binge drinking through conversational valence was revealed .", "when participants viewed an anti-alcohol message , they reported significantly more negative conversations about alcohol .", "subsequently , a more negative conversational valence about alcohol increased the intention to refrain from binge drinking .", "these findings suggest that conversational valence is relevant for health campaign effects .", "by demonstrating that health messages can influence this valence , important implications arise in terms of health promotion .", "future research should focus on how to design effective health campaigns that are able to guide conversational valence in the desired direction ." ]

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

[ "recent interest has focused on the definition and measurement of clinical remission in people with schizophrenia .", "this study examined the process of development of `` functional remission '' in a long-term comparative double-blind study of haloperidol and the atypical antipsychotic medication ziprasidone .", "community dwelling patients with schizophrenia were randomized to treatment with haloperidol ( n = @ ) or ziprasidone dosed either once or twice daily ( n = @ ) .", "they were re-examined at follow-up intervals that ranged up to @ weeks .", "their community functioning was examined with the heinrichs-carpenter quality of life scale ( qls ) .", "total scores for occupational and interpersonal functioning and achievement of improvement milestones across the individual items were both analyzed .", "mixed model repeated measures analyses detected a significant ( p < @ ) treatment effect over time favoring ziprasidone for interpersonal functioning .", "while the mixed model was not significant for role functioning , the mean change at endpoint was significantly greater than @ for the ziprasidone group but not the haloperidol group .", "analyses of the distributions of change scores across the items showed that the number of items where endpoint scores were @ or @ ( reflecting minimal to no impairment ) was significantly higher in ziprasidone treated patients , ( p = @ ) .", "long term treatment with ziprasidone was associated with greater functional gains than treatment with haloperidol , even when the time course of dropout was controlled .", "both treatment retention and functional gains favored the atypical treatment in this long-term study .", "future long-term studies will be needed to clarify the determinants of these functional changes ." ]

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

[ "we aimed to characterize the pharmacokinetics and pharmacodynamics of drotrecogin alfa ( activated ) ( recombinant human activated protein c ) in patients with severe sepsis .", "patients ( n = @ ) in a randomized , double-blind , placebo-controlled phase @ trial received a @-hour infusion of placebo ( n = @ ) or drotrecogin alfa ( activated ) ( n = @ ) , @ microg x kg ( -@ ) x h ( -@ ) .", "plasma samples from @ patients were collected for pharmacokinetic assessment .", "pharmacodynamic effects on activated partial thromboplastin time , d-dimer , protein c , and interleukin @ were analyzed by drotrecogin alfa ( activated ) steady-state plasma concentration ( c ( ss ) ) quartile .", "transient endogenous activated protein c concentrations above @ ng/ml were observed in @ placebo-treated patients ( @ % ) .", "in drotrecogin alfa ( activated ) - treated patients , the median c ( ss ) was @ ng/ml and the median plasma clearance ( cl ( p ) ) was @ l/h .", "c ( ss ) was reached within @ hours after the infusion was started .", "plasma concentrations were below the assay quantitation limit of @ ng/ml within @ hours after the infusion was stopped in @ % of patients .", "cl ( p ) increased with increasing body weight , so infusion rates should be based on predose body weight .", "mean cl ( p ) associated with age , sex , or baseline hepatic or renal function differed by less than @ % from the mean cl ( p ) in all patients and resided within the interquartile range of cl ( p ) in all patients .", "dose adjustment is not required on the basis of these factors alone or in combination .", "no correlation was detected between c ( ss ) quartile and bleeding risk or the magnitudes of effect on biomarkers of coagulopathy ( d-dimers and protein c ) and inflammation ( interleukin @ ) .", "plasma concentrations of drotrecogin alfa ( activated ) attain steady state rapidly after the infusion is started and decline rapidly after the infusion is stopped .", "the infusion rate should be based on predose body weight and not on any other demographic or baseline clinical covariate ." ]

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

[ "infections caused by carbapenemase-producing enterobacteriaceae are increasing worldwide , especially in icus , and have been associated with high mortality rates .", "however , unequivocally demonstrating causality of such infections to death is difficult in critically ill patients because of potential confounding and competing events .", "here , we quantified the effects of carbapenemase-producing enterobacteriaceae carriage on patient outcome in two greek icus with carbapenemase-producing enterobacteriaceae endemicity .", "observational cohort study .", "two icus with carbapenemase-producing enterobacteriaceae endemicity .", "patients admitted to the icu with an expected length of icu stay of at least @ days were included .", "none .", "carbapenemase-producing enterobacteriaceae colonization was established through screening in perineum swabs obtained at admission and twice weekly and inoculated on chromogenic plates .", "detection of carbapenemases was performed phenotypically , with confirmation by polymerase chain reaction .", "risk factors for icu mortality were evaluated using cause-specific hazard ratios and subdistribution hazard ratios , with carbapenemase-producing enterobacteriaceae colonization as time-varying covariate .", "one thousand seven patients were included , @ ( @ % ) were colonized at admission , and @ ( @ % ) acquired carbapenemase-producing enterobacteriaceae colonization during icu stay , and @ ( @ % ) died in icu .", "of @ carbapenemase-producing enterobacteriaceae isolates , @ ( @ % ) were klebsiella pneumoniae and @ harbored k. pneumoniae carbapenemase ( @ % ) , @ metallo -- lactamase ( @ % ) , and four both ( @ % ) .", "carbapenemase-producing enterobacteriaceae colonization was associated with a statistically significant increase of the subdistribution hazard ratio for icu mortality ( subdistribution hazard ratio = @ ; @ % ci , @-@ @ ) , not explained by an increased daily hazard of dying ( cause-specific hazard ratio for death = @ ; @ % ci , @-@ @ ) , but by an increased length of stay ( cause-specific hazard ratio for discharge alive = @ ; @ % ci , @-@ @ ) .", "other risk factors in the subdistribution hazard model were acute physiology and chronic health evaluation ii score ( subdistribution hazard ratio = @ ; @ % ci , @-@ @ ) , female gender ( subdistribution hazard ratio = @ ; @ % ci , @-@ @ ) , presence of solid tumor ( subdistribution hazard ratio = @ ; @ % ci , @-@ @ ) , hematopoietic malignancy ( subdistribution hazard ratio = @ ; @ % ci , @-@ @ ) , and immunodeficiency ( subdistribution hazard ratio = @ ; @ % ci , @-@ @ ) .", "patients colonized with carbapenemase-producing enterobacteriaceae have on average a @ times higher hazard of dying in icu than noncolonized patients , primarily because of an increased length of stay ." ]

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

[ "transdermal progesterone is being used in some countries as a purported treatment for menopausal symptoms , either alone or prescribed in conjunction with estrogen , but little information exists regarding the biological activity and effectiveness of this method of delivery of progesterone in protecting the endometrium from excess proliferation .", "this study was designed to evaluate the use of sequential transdermal progesterone .", "end-points evaluated included endometrial cellular response and bleeding pattern as well as plasma hormone levels and salivary progesterone estimations .", "twenty-seven postmenopausal women were treated with continuous transdermal estrogen ( @-day cycle ) and a cream containing @ , @ or @ mg of progesterone in each @-cm extrusion from a tube of pro-feme administered daily in a sequential ( days @-@ of cycle ) regimen .", "blood and endometrial samples were analyzed for progesterone response prior to therapy , after the first @ days of unopposed transdermal estrogen and following @ days of transdermal progesterone .", "saliva samples were taken during the last @ days of the @-day study , when the final progesterone cream therapy was being applied .", "hormone assay indicated that physiological levels of estradiol were achieved , but progesterone levels were insufficient to induce any detectable change in the endometrium .", "only one patient experienced bleeding during the study period .", "levels of salivary progesterone were so variable as to be considered completely unreliable in determining the potential influence on biological activity .", "pro-feme transdermal progesterone administered in a @ - , @ - or @-mg daily dose for @ days in a sequential regimen does not appear to be effective in inducing a secretory change in a proliferative endometrium .", "salivary progesterone levels were not of value in managing the therapy of postmenopausal women ." ]

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

[ "barbed sutures have unidirectional circumferential shallow barbs , which distribute tension throughout the wound and close wound securely without the need to tie knots .", "we compare two different methods of wound closure in elective plastic surgical cases : barbed @/@v-loc @ suture and smooth @/@maxon sutures , both polyglyconate monofilament synthetic absorbable sutures .", "we assessed the aesthetic long-term results with a minimum two year follow up .", "this is a prospective , randomized controlled study with internal control .", "a single surgeon performed all cases .", "patients who underwent elective operations that involved long wound closure were enrolled in the study .", "each patient acted as their own internal control with half their wound being sutured with @/@v-loc @ barbed suture and the other half with smooth @/@maxon deep dermal sutures and then a subcuticular skin closure .", "in both groups , the superficial fascial system was closed with @ vicryl interrupted sutures on both sides .", "long-term cosmesis was evaluated using the modified hollander cosmesis score by review of standardized postoperative photographs by @ blinded plastic surgeons and specialist registrars .", "the study reports on @ female patients .", "the time taken for wound closure was significantly reduced using the barbed suture ( p < @ ) .", "there was no difference in the complication ratio in either group .", "two-year aesthetic outcome was significantly superior when using the barbed suture ( p = @ ) .", "barbed sutures closure of long wounds is faster and produces a better long-term aesthetic outcome than smooth sutures ." ]

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

[ "plant sterol ( ps ) - enriched foods have been shown to reduce plasma ldl-cholesterol concentrations .", "in most studies , however , pss were incorporated into food products of high fat content .", "we examined the effect of daily consumption of ps-supplemented low-fat fermented milk ( fm ) on the plasma lipid profile and on systemic oxidative stress in hypercholesterolemic subjects .", "hypercholesterolemic subjects ( ldl-cholesterol concentrations > or = @ and < or = @ mg/dl ; n = @ ) consumed @ low-fat portions of fm in the same meal daily for @ wk .", "subjects were randomly assigned to @ groups : low-fat fm enriched with @ g ps ester per portion or control fm .", "plasma concentrations of lipids , oxidized ldl , beta-carotene , beta-sitosterol , campesterol , and high-sensitivity c-reactive protein were measured during the trial .", "plasma ldl-cholesterol concentrations were reduced by @ % and @ % after @ and @ wk , respectively , in the @-g / d ps group compared with the control group , whereas plasma triacylglycerol and hdl-cholesterol concentrations were not significantly affected .", "in addition , there were no significant changes in serum beta-carotene on normalization to ldl cholesterol during the study period in both groups , whereas plasma concentrations of oxidized ldl were reduced significantly in the ps group compared with the control group ( -@ compared with @ u/l , respectively ; p < @ ) .", "plasma sitosterol concentrations were increased by @ % ( p < @ compared with control ) ; however , campesterol concentrations did not change during the study period .", "daily consumption of @ g ps in low-fat fm efficiently lowers ldl cholesterol in subjects with moderate hypercholesterolemia without deleterious effects on biomarkers of oxidative stress ." ]

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

[ "this study describes baseline and year @ predictors of abstinence from smoking for the @,@ intervention participants who had complete annual @-year follow-up data in the lung health study ( lhs ) .", "the lhs enrolled @,@ smokers , aged @ to @ years , of whom @,@ were offered a cessation intervention .", "of these , @ % achieved biochemically verified abstinence for @ years .", "logistic regressions were performed .", "the first outcome variable was abstinence from smoking at @ year .", "then for those who were quit at @ year , the outcome variable was @ years of sustained abstinence .", "all participants who were not using nicotine gum after @ year in the study were more likely to sustain cessation over @ years than were gum users at year @ ( or ranged from @ to @ for four age - and sex-specific groups ) .", "baseline number of previous quit attempts was negatively associated with @-year quitting success among younger and older men ( or = @ and @ ) .", "older participants who were less likely to associate smoking with emotional coping had higher abstinence rates at @ years of follow-up ( or = @ and @ ) .", "different mechanisms may be responsible for achieving cessation in age/gender groups .", "these results have implications for planning successful interventions ." ]

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

[ "patients with diabetes mellitus are at increased risk for microvascular complications .", "early changes in microcirculation are characterized by hyperperfusion ( e.g. in the retina and kidney ) and increased pulse wave reflection leading to increased aortic pressure .", "we investigated the effects of the dpp-@-inhibitor saxagliptin on early retinal microvascular changes .", "in this double-blind , controlled , cross-over trial @ patients ( without clinical signs of microvascular alterations ) with type-@ diabetes ( mean duration of @ years ) were randomized to receive placebo or @mg saxagliptin for @ weeks .", "retinal arteriolar structure and retinal capillary flow ( rcf ) at baseline and during flicker-light exposure was assessed by scanning laser doppler flowmetry .", "central hemodynamics were assessed by pulse wave analysis .", "postprandial blood glucose ( @ versus @ mmol/l ; p = @ ) and hba@c ( @ ( @ ) versus @ % ( @ mmol/mol ) ; p < @ ) were significantly reduced with saxagliptin treatment compared to placebo .", "rcf was significantly reduced after treatment with saxagliptin ( @ versus @ au ; p = @ ) .", "this was most pronounced in a subgroup of patients ( n = @ ) with a fall in postprandial blood glucose ( @ versus @ au ; p = @ ) .", "no significant changes in rcf were seen during flicker-light exposure between placebo and saxagliptin , but the vasodilatory capacity increased two-fold with saxagliptin treatment .", "central augmentation pressure tended to be lower after treatment with saxagliptin ( p = @ ) , and central systolic blood pressure was significantly reduced ( @ versus @ mmhg ; p = @ ) .", "our data suggest that treatment with saxagliptin for @ weeks normalizes retinal capillary flow and improves central hemodynamics in type-@ diabetes .", "the study was registered at ( id : nct@ ) ." ]

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

[ "the purpose of this study was to evaluate the extended efficacy , safety , and tolerability of escitalopram relative to placebo in adolescents with major depressive disorder ( mdd ) .", "adolescents ( @-@ years ) who completed an @-week randomized , double-blind , flexible-dose , placebo-controlled , lead-in study of escitalopram @-@ mg versus placebo could enroll in a @-@-week , multisite extension trial ; patients maintained the same lead-in randomization ( escitalopram or placebo ) and dosage ( escitalopram @ or @ mg/day , or placebo ) during the extension .", "the primary efficacy was children 's depression rating scale-revised ( cdrs-r ) change from the lead-in study baseline to treatment week @ ( @-week lead-in study plus @-week extension ) ; the secondary efficacy was clinical global impressions-improvement ( cgi-i ) score at week @ .", "all efficacy analyses used the last observation carried forward ( locf ) approach ; sensitivity analyses used observed cases ( oc ) and mixed-effects model for repeated measures ( mmrm ) .", "safety was evaluated via adverse event ( ae ) reports and the clinician-rated columbia-suicide severity rating scale ( c-ssrs ) .", "following lead-in , @ patients enrolled in the double-blind extension ( @ placebo ; @ escitalopram ) ; @ ( @ % ) placebo and @ ( @ % ) escitalopram patients completed treatment .", "cdrs-r total score improvement was significantly greater for escitalopram than for placebo ( p = @ , locf ; p = @ ; mmrm ) .", "response rates ( cdrs-r @ % reduction from baseline [ adjusted and unadjusted ] and cgi-i @ ) were significantly higher for escitalopram than for placebo ( locf ) ; remission rates ( cdrs-r @ ) were @ % for escitalopram and @ % for placebo ( p = @ ) .", "oc analyses were not significantly different between groups .", "the most frequent escitalopram aes ( @ % and more frequent than placebo ) were headache , nausea , insomnia , vomiting , influenza-like symptoms , diarrhea , and urinary tract infection .", "most aes were mild/moderate and not related to the study drug .", "aes suggestive of self-harm occurred in @ % and @ % of placebo and escitalopram patients .", "occurrence of suicidal behavior and/or suicidal ideation assessed by c-ssrs was @ % ( @/@ ) for placebo and @ % ( @/@ ) for escitalopram .", "extended use of escitalopram was generally safe and resulted in modest improvement in efficacy in adolescents with mdd ." ]

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

[ "some precursor p wave changes on electrocardiogram ( ecg ) before the atrial fibrillation ( af ) episodes occur in the hyperthyroidism .", "our aim was to compare the effect of two antithyroid drugs ( atd ) on p wave duration and dispersion ( pwd ) in patients with hyperthyroidism .", "fifty patients ( @ men , @ women ; mean age @ + / -@ years ) with newly diagnosed overt hyperthyroid patients with graves ' disease ( gd ) were enrolled in the prospective , randomized study .", "the maximum p wave duration ( pmax ) and the minimum p wave duration ( pmin ) were measured in all @-lead surface ecgs .", "the patients were consecutively randomized to propylthiouracil ( ptu ) ( n = @ ) and methimazole ( mmz ) ( n = @ ) groups .", "electrocardiogram was repeated within euthyroid state after the @-month atd treatment .", "student t-test , mann-whitney u and pearson chi-square tests were used for comparisons of the data between groups .", "the differences between pre - and post-treatment measurements within groups were evaluated by wilcoxon sign rank test .", "the correlation of data was tested by using spearman correlation analysis .", "the maximum p wave duration ( pmax ) was @ ( @-@ ) and @ ( @-@ ) msec , ( p = @ ) , and pwd was @ ( @-@ @ ) and @ ( @-@ ) msec , respectively ( p = @ ) in ptu and mmz groups .", "after euthyroidism was achieved , pmax was @ ( @-@ ) and @ ( @-@ ) msec ( p = @ ) , and pwd was @ ( @-@ ) and @ ( @-@ ) msec in ptu and mmz groups , respectively ( p = @ ) .", "after atd treatment pwd decreased ( p = @ and p < @ , respectively ) in both of ptu and mmz groups .", "however effects of atd on pwd change were similar ( p = @ ) .", "p wave duration and pwd are found to be prolonged in hyperthyroid patients with gd .", "both propylthiouracil and methimazole reduce the p wave duration and dispersion .", "thus , we can conclude that improvements in atrial conduction properties are not associated with the type of atd but with only achievement of euthyroidism ." ]

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

[ "the context of the study is the increased assessment and treatment of persons with mental illness in general hospital settings by general health staff , as the move away from mental hospitals gathers pace in low and middle income countries .", "the purpose of the study was to examine whether general attitudes of hospital staff towards persons with mental illness , and extent of mental health training and clinical experience , are associated with different attitudes and behaviours towards a patient with mental illness than towards a patients with a general health problem - diabetes .", "general hospital health professionals in malaysia were randomly allocated one of two vignettes , one describing a patient with mental illness and the other a patient with diabetes , and invited to complete a questionnaire examining attitudes and health care practices in relation to the case .", "the questionnaires completed by respondents included questions on demographics , training in mental health , exposure in clinical practice to people with mental illness , attitudes and expected health care behaviour towards the patient in the vignette , and a general questionnaire exploring negative attitudes towards people with mental illness .", "questionnaires with complete responses were received from @ study participants .", "stigmatising attitudes towards persons with mental illness were common .", "those responding to the mental illness vignette ( n = @ ) gave significantly lower ratings on care and support and higher ratings on avoidance and negative stereotype expectations compared with those responding the diabetes vignette ( n = @ ) .", "results support the view that , in the malaysian setting , patients with mental illness may receive differential care from general hospital staff and that general stigmatising attitudes among professionals may influence their care practices .", "more direct measurement of clinician behaviours than able to be implemented through survey method is required to support these conclusions ." ]

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

[ "craving or the `` urge to consume '' is a characteristic of bulimic eating disorders and addictions .", "dysfunction of the dorsolateral prefrontal cortex ( dlpfc ) is associated with craving .", "we investigated whether stimulation of the dlpfc reduces food craving in people with a bulimic-type eating disorder .", "thirty-eight people with bulimic-type eating disorders were randomly allocated to receive one session of real or sham high-frequency repetitive transcranial magnetic stimulation ( rtms ) to the left dlpfc in a double-blind procedure .", "outcome measures included self-reported food craving immediately after the stimulation session and frequency of bingeing over a @-hour follow-up period .", "compared with sham control , real rtms was associated with decreased self-reported urge to eat and fewer binge-eating episodes over the @ hours following stimulation .", "high-frequency rtms of the left dlpfc lowers cue-induced food cravings in people with a bulimic eating disorder and may reduce binge eating .", "these results provide a rationale for exploring rtms as a treatment for bulimic eating disorders ." ]

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

[ "during the reproductive years , most of menstruating women experience symptoms of premenstrual syndrome ( pms ) , which is incapacitating in up to @ % of cases .", "according to complicated etiology , various therapeutic approaches have been proposed .", "because pms is a chronic situation , special attention should be paid to the side-effects of pharmacological interventions .", "herbal medicine is a recent favorable therapeutic approach owing to fewer side-effects .", "we aimed to determine the effect of ginkgo biloba l. on the symptoms of pms .", "this was a single-blind , randomized , placebo-controlled trial conducted from november @ to april @ .", "the students with pms , living in dormitories of a medical university ( tehran ) , who met the inclusion criteria entered the study .", "the students filled out the daily symptom rating forms in two consecutive menstrual cycles .", "after we verified the pms diagnosis in @ students , the participants were randomly assigned to experiment and placebo groups and took g. biloba l. tablets ( containing @ mg leaf extracts ) or placebo three times a day from the @th day of the menstrual cycle to the @th day of the next cycle .", "data were collected using daily symptom rating forms .", "eighty-five ( @ , @ % ) participants completed the study .", "the two groups were similar in terms of demographic characteristics and baseline overall severity of symptoms .", "after the intervention , there was a significant decrease in the overall severity of symptoms and physical and psychologic symptoms in both ginkgo ( @ % ) and placebo ( @ % ) groups ( p < @ ) .", "however , the mean decrease in the severity of symptoms was significantly more in the ginkgo group compared to the placebo group ( p < @ ) .", "g. biloba l. can reduce the severity of pms symptoms .", "further research on active ingredients and also the efficacy and safety of various doses and treatment durations of ginkgo are required ." ]

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

[ "this study was designed to examine the efficacy of chinese herbal medicine ( chm ) in the treatment of chronic rhinosinusitis ( crs ) without nasal polyps .", "patients with crs without nasal polyps were enrolled in the study .", "before treatment , they were evaluated by the taiwanese version of the @-item sino-nasal outcome test ( twsnot-@ ) , nasal endoscopy , saccharin test , and bacterial culture .", "then , they were randomized to take chm ( tsang-erh-san extract granules and houttuynia extract powder ) or erythromycin for @ weeks .", "after treatment , they were evaluated again by the twsnot-@ , nasal endoscopy , saccharin test , and bacterial culture .", "fifty-three patients completed the study with @ in the chm group and @ in the erythromycin group .", "in both the chm and the erythromycin groups , twsnot-@ scores significantly decreased after treatment , but the decrease was not significantly different between the two groups .", "however , the saccharin transit times were shortened in more patients in the chm group than in patients in the erythromycin group .", "our results showed chm had an efficacy similar to that of macrolides in the treatment of crs without nasal polyps .", "however , a placebo effect remained possible in both treatment groups ." ]

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

[ "to evaluate preoperative rectal electrical stimulation in the recovery of urinary continence in patients who undergo radical retropubic prostatectomy .", "patients were divided into @ randomized groups : control , pelvic exercises , and electrical stimulation .", "a @ hour pad-test , the iciq-sf , and the sf-@ were performed @ , @ , and @ months after the surgical procedure .", "of the @ patients who were initially included in the study , @ were excluded due to radiotherapy after surgical intervention , an indwelling urethral catheter for more than @ days , high surgical risk , loss of follow-up , or incomplete participation in the study routines and spontaneous interruption .", "forty-nine patients concluded the study ( @ in the control group , @ in the exercise group , and @ in the electrical stimulation group ) .", "we did not observe any significant difference in the pad test ( p > @ ) , the @ domains of the sf-@ , or iciq-sf score compared with control groups ( control , exercise , and electrical stimulation ) .", "preoperative rectal electrical stimulation has no impact on continence status in patients who undergo radical retropubic prostatectomy .", "there is no difference in the three above mentioned groups with regard to urinary leakage and quality of life ." ]

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

[ "the indication to treat paroxysmal atrial fibrillation ( paf ) is controversial .", "the suppression of paroxysmal atrial tachyarrhythmias ( sopat ) trial was designed to answer the following questions : ( @ ) what is the average rate of spontaneous events of symptomatic paf with and without anti-arrhythmic medication ?", "( @ ) what is the prevalence of severe side-effects ?", "and ( @ ) is the fixed combination of quinidine + verapamil inferior to the efficacy of sotalol or not ?", "within @ months @ centres in germany , poland , and the slovak republic prospectively enrolled @ patients ( mean age @ years , @ % male ) with documented frequent episodes of symptomatic paf .", "patients were randomised to either quinidine + verapamil @/@ mg/d ( high dose ; @ patients ) , quinidine + verapamil @/@ mg/d ( low dose ; @ patients ) , sotalol @ mg/d ( @ patients ) or placebo ( @ patients ) , of which @ patients entered the intention-to-treat analysis .", "the primary endpoint was the time to first recurrence of symptomatic paf or premature discontinuation .", "secondary outcome parameters were the total number of symptomatic episodes and tolerability of the tested drugs .", "patients were followed for a period of up to @ months by daily and symptom-triggered trans-telephonic ecg-monitoring ( tele-ecg ) .", "the mean time under treatment was @ + / - @ days .", "regarding the primary endpoint , all active treatments were superior to placebo and not different from each other .", "a total of @ patients reached the primary endpoint within @ + / - @ d ( mean + / - sem ) in the placebo group , vs. quinidine + verapamil ( high dose ) ( @ + / - @ d , p = @ ) , vs. quinidine + verapamil ( low dose ) ( @ + / - @ d , p = @ ) , vs. sotalol ( @ + / - @ d , p = @ ) .", "all three treatments were also effective in the reduction of af burden ( days with symptomatic af [ % ] mean + / - sd , p vs. placebo ) : quinidine + verapamil ( high dose ) ( @ + / - @ , p = @ ) , quinidine + verapamil ( low dose ) ( @ + / - @ , p = @ ) and sotalol ( @ + / - @ , p = @ ) compared to placebo ( @ + / - @ ) .", "a total of four deaths , @ syncopes , and one ventricular tachycardia ( vt ) occurred during the active study period , of which one death and one vt were related to quinidine/verapamil .", "taken together , anti-arrhythmic therapy with the fixed combination of quinidine + verapamil is as effective as sotalol in the reduction of the recurrence rate of symptomatic paf with a low but definite risk of severe side-effects ." ]

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

[ "to evaluate the efficacy of a thermosensitive atelocollagen punctal plug in the treatment of dry eye disease .", "prospective observational case series .", "the thermosensitive atelocollagen punctal plug was warmed at @ c , @ c , @ c , and @ c to evaluate the appropriate temperature and time for solidification .", "dry eye patients were divided into @ groups according to the preparation method of the atelocollagen punctal plug .", "in the conventional implantation group , atelocollagen gel was kept at room temperature for @ minutes before implantation ( @ eyes of @ patients ) .", "in the preheating group , atelocollagen was warmed at @ c for @ minutes before implantation ( @ eyes of @ dry eye patients ) .", "strip meniscometry , vital stainings , tear film break-up time ( but ) , and symptom scores were evaluated before and @ month after plug implantation .", "in vitro experiments revealed that heating at @ c for @ minutes was sufficient to solidify the gel .", "the mean fluorescein score in the conventional implantation group significantly improved after treatment ( before , @ @ points ; after , @ @ points , p < @ ) .", "in the preheating group , the mean fluorescein score ( before , @ @ points ; after , @ @ points ) , strip meniscometry ( before , @ @ mm ; after , @ @ mm ) , but ( before , @ @ seconds ; after , @ @ seconds ) , and visual analog scale scores ( before , @ @ points ; after , @ @ points ) significantly improved after treatment ( p < @ ) .", "the thermosensitive atelocollagen punctal plug was effective for dry eye treatment .", "the preheating method was found to be useful to strengthen the efficacy of the thermosensitive atelocollagen punctal plug ." ]

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

[ "recovery from general anesthesia is governed by pharmacodynamic and pharmacokinetic factors .", "gender has not previously been recognized as a factor influencing the time to emergence from general anesthesia .", "this multicenter study was originally designed to measure the effects of the bispectral index on intraoperative anesthetic management and patient recovery .", "we compared the wake-up and recovery times of @ adults after propofol/alfentanil/nitrous oxide anesthesia .", "patients were randomly assigned to have the titration of propofol performed with or without the use of bispectral index monitoring .", "specific guidelines were given for the titration of drugs .", "the aim in all cases was to provide a safe anesthetic with the fastest possible recovery .", "there was a significant reduction in propofol dose , time to eye opening , and response to verbal command when the anesthetic was titrated using the bispectral index .", "unexpectedly , gender proved to be a highly significant independent predictor for recovery time .", "women woke significantly faster than men : the time from end of anesthesia to eye opening was @ versus @ min , p < @ , and response to verbal command was @ versus @ min , p < @ .", "these differences were significant at all four study sites and in each treatment group .", "men consistently had prolonged recovery times compared to women , p < @ .", "there was no difference in the dose of anesthetic used between gender .", "gender appears to be an important variable in recovery from general anesthesia .", "these findings may explain the increased reported incidence of awareness in women ( three times more frequent ) and support the need to include gender as a variable in pharmacokinetic and pharmacodynamic studies of anesthetic drugs ." ]

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

[ "to investigate whether an exercise program , initially focusing on knee stabilization and subsequently on muscle strength and performance of daily activities is more effective than an exercise program focusing on muscle strength and performance of daily activities only , in reducing activity limitations in patients with knee osteoarthritis ( oa ) and instability of the knee joint .", "a single-blind , randomized , controlled trial involving @ knee oa patients with self-reported and/or biomechanically assessed knee instability , randomly assigned to two treatment groups .", "both groups received a supervised exercise program for @ weeks , consisting of muscle strengthening exercises and training of daily activities , but only in the experimental group specific knee joint stabilization training was provided .", "outcome measures included activity limitations ( western ontario and mcmaster universities osteoarthritis index - womac physical function , primary outcome ) , pain , global perceived effect and knee stability .", "both treatment groups demonstrated large ( @-@ % ) and clinically relevant reductions in activity limitations , pain and knee instability , which were sustained @ months post-treatment .", "no differences in effectiveness between experimental and control treatment were found on womac physical function ( b ( @ % confidence interval - ci ) = -@ ( -@ to @ ) ) or secondary outcome measures , except for a higher global perceived effect in the experimental group ( p = @ ) .", "both exercise programs were highly effective in reducing activity limitations and pain and restoring knee stability in knee oa patients with instability of the knee .", "in knee oa patients suffering from knee instability , specific knee joint stabilization training , in addition to muscle strengthening and functional exercises , does not seem to have any additional value .", "dutch trial register ( ntr ) registration number : ntr@ ." ]

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

[ "sustained hypotension after an acute dynamic exercise bout is due primarily to peripheral vasodilation .", "we tested the hypothesis that adenosine-mediated vasodilation contributes to hypotension after exercise , by determining the effect of blocking its actions with caffeine .", "fourteen healthy middle-aged subjects ( mean age = @ + / - @ years ) , cycled to peak effort on @ study days , after a randomized double-blind intravenous infusion of caffeine ( @ mg/kg ) selective for adenosine receptor blockade , or vehicle .", "both studies were performed after @ h of caffeine abstinence .", "infusion achieved @ + / - @ mumol/l caffeine in plasma .", "significant reductions in mean and diastolic blood pressure ( bp ) were elicited by prior exercise on the vehicle day ( from @ + / - @ to @ + / - @ mm hg v from @ + / - @ to @ + / - @ mm hg , respectively ; both p < @ ) , but not after caffeine infusion .", "systolic and mean bp , @ min after exercise , were higher on the caffeine than on the vehicle day ( by @ + / - @ and @ + / - @ mm hg , respectively ; p < @ ) , as was heart rate ( hr ) ( @ + / - @ v @ + / - @ beats/min ; p < @ ) .", "these data suggest that endogenous adenosine contributes to early hypotension after exercise in healthy middle-aged subjects and underscore the importance of caffeine abstinence if bp or hr immediately after exercise is used to infer cardiovascular risk ." ]

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

[ "to determine whether acepromazine ( ace ) and butorphanol ( but ) combination can be used for restraint of dogs during positive-contrast upper gastrointestinal tract ( ugit ) examination .", "@ healthy dogs .", "in a randomized crossover design study , weekly ugit examinations were performed on each dog for @ weeks after administration of normal saline solution ( @ ml ) , xylazine ( @ mg/kg of body weight ) , or a combination of ace ( @ mg/kg ) and @ of @ doses of but ( @ , @ , @ mg/kg ) .", "gastrointestinal tract emptying time , gi motility , pulse , respiratory rate , and quality of restraint were assessed .", "total gastric emptying time was significantly prolonged by use of an ace and but ( @ mg/kg ) combination .", "xylazine and higher dosages of but significantly prolonged gastric and intestinal emptying times .", "all anesthetic protocols significantly decreased motility and facilitated nonmanual restraint .", "xylazine and but ( @ mg/kg ) significantly decreased pulse and respiratory rate .", "the ace and but combination prolonged gi tract emptying times , decreased gi motility , and facilitated nonmanual restraint for duration of the examination .", "although gi motility was decreased and total gastric emptying time was prolonged , administration of ace ( @ mg/kg ) plus but ( @ mg/kg ) allowed morphologic examination of the gi tract within @ hours .", "xylazine prolonged gi tract emptying , decreased gi motility , and provided good to excellent initial restraint .", "clinical relevance-the ace and but combination prohibits functional examination of the gi tract ; however , morphologic examination is possible when low dosages of but ( @ mg/kg ) are used ." ]

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

[ "a substantial proportion of patients with gastro-oesophageal reflux disease ( gerd ) have only a partial response to proton pump inhibitor ( ppi ) therapy .", "prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying .", "to evaluate the effect of revexepride , a novel prokinetic @-hydroxytryptamine type @ ( @-ht@ ) receptor agonist , compared with placebo , in patients with gerd who have a partial response to ppis .", "a phase @b , double-blind , parallel-group study was conducted , in which patients were randomised to one of three revexepride treatment groups ( @ , @ and @ mg three times daily ) or placebo ( @:@:@:@ ratio ) .", "daily e-diary data captured patients ' symptoms over an @-week treatment period .", "the primary efficacy outcome was the weekly percentage of regurgitation-free days in the second half of the study ( weeks @-@ ) .", "in total , @ patients were randomised and @ received treatment ( mean age @ years ; @ % women ) .", "the mean percentage of regurgitation-free days increased from baseline ( range , @-@ @ % ) to week @ ( @-@ @ % ) in all four study arms ; however , there were no statistically significant differences in this change between placebo and the three treatment arms .", "no dose-dependent relationship in treatment effect was observed for any of the study endpoints .", "the incidence of treatment-emergent adverse events ( teaes ) was revexepride dose-dependent .", "only one serious teae occurred and none resulted in death .", "revexepride was no more effective than placebo in controlling regurgitation in patients with gerd symptoms partially responsive to ppis .", "revexepride was well tolerated .", "clinicaltrials.gov identifier : nct@ ." ]

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

[ "it is accepted that preventing hyperglycaemia during critical illness while assuring adequate caloric intake can reduce mortality and morbidity .", "the aim of this study was to compare the metabolic effects of metformin and insulin on hyperglycaemia in icu patients .", "this double-blind randomised clinical trial was performed on @ patients who were admitted to the intensive care unit ( icu ) from @ march to @ september @ .", "all patients with serious injuries or with major non-abdominal surgeries were included if they met the inclusion criteria , and were assigned randomly to one of the study groups .", "patients in group @ received intensive insulin therapy , and patients in group @ were treated with metformin .", "moreover , the acute physiology and chronic health evaluation ( apache ) ii scoring system was used to grade disease severity .", "both glycaemic management protocols led to significantly improved glucose levels without any report of hypoglycaemia .", "the mean initial glucose levels for the insulin group decreased significantly after the intravenous infusion of insulin ( p < @ ) .", "additionally , the blood glucose concentration was significantly lower after two weeks of metformin administration compared to baseline measurements ( p < @ ) .", "moreover , the blood glucose concentration decrease during these two weeks was significantly higher in the insulin group ( p = @ ) .", "besides , apache ii score was lower than baseline at the end of the study for both therapeutic groups ( score of @ vs. @ [ insulin ] and @ [ metformin ] ) .", "finally , new renal dysfunction ( maximum serum creatinine level at least double the initial value ) was observed in three of the patients ( two patients from the metformin group and one from the insulin group ) in the last days of the protocol , although none of the patients showed lactic acidosis after icu admission .", "both metformin and intensive insulin therapy significantly decreased hyperglycaemia in icu patients .", "insulin caused a greater reduction in blood glucose concentration but required more attention and trained personnel ." ]

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

[ "we investigated the effects of pravastatin on chylomicron remnant catabolism measured with a @c stable isotope breath test and plasma apolipoprotein ( apo ) b-@ and remnant-like particle ( rlp ) - cholesterol in postmenopausal women with type @ diabetes mellitus .", "nineteen postmenopausal women with type @ diabetes were randomized to receive @ mg/day pravastatin or no treatment for @ weeks followed by a @-week washout period , and crossed over for a further @ weeks .", "fractional catabolic rate ( fcr ) of a chylomicron remnant-like emulsion was determined from @co@ enrichment in the breath and plasma using isotope-ratio mass spectrometry and multicompartmental modelling .", "plasma apo b-@ and rlp-cholesterol concentrations were also measured as static markers of chylomicron remnant metabolism .", "pravastatin significantly reduced plasma concentrations of cholesterol ( @ + / - @ vs. @ + / - @ mmol/l ; p < @ ) , low density lipoprotein ( ldl ) - cholesterol ( @ + / - @ vs. @ + / - @ mmol/l ; p < @ ) , triglyceride ( @ + / - @ vs. @ + / - @ mmol/l ; p = @ ) , non-high density lipoprotein ( hdl ) - cholesterol ( @ + / - @ vs. @ + / - @ mmol/l ; p < @ ) , lathosterol/total cholesterol ratio ( @ + / - @ vs. @ + / - @ , p = @ ) , apo b-@ ( @ + / - @ vs. @ + / - @ g/l ; p = @ ) , apo b-@ ( @ + / - @ vs. @ + / - @ mg/l ; p = @ ) , and rlp-cholesterol ( @ + / - @ vs. @ + / - @ mg/dl ; p = @ ) .", "pravastatin was also associated with an increase in sitosterol/total cholesterol ratio ( @ + / - @ vs. @ + / - @ , p = @ ) .", "chylomicron remnant-like emulsion catabolism was not , however , significantly altered by pravastatin estimated by either breath or plasma clearance measurements .", "in postmenopausal women , pravastatin decreases plasma concentrations of remnant lipoproteins by a mechanism that may relate chiefly to inhibition of remnant production , but this requires further evaluation ." ]

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

[ "this trial evaluated the efficacy and safety of pregabalin dosed twice daily ( bid ) for relief of neuro-pathic pain associated with postherpetic neuralgia ( phn ) .", "the @-week , double-blind , placebo-controlled study randomized @ patients with phn to pregabalin ( @ , @ , or @ mg/day bid ) or placebo .", "primary efficacy measure was endpoint mean pain score from daily pain diaries .", "secondary efficacy measures included endpoint mean sleep-interference score from daily sleep diaries and patient global impression of change ( pgic ) .", "safety evaluations included adverse events ( aes ) , physical and neurologic examinations , @-lead ecg , vital signs , and laboratory testing .", "pregabalin provided significant , dose-proportional pain relief at endpoint : difference from placebo in mean pain score , @ mg/day , -@ , p = @ ; @ mg/day , -@ , p = @ ; @ mg/day , -@ , p = @ .", "weekly mean pain scores significantly improved as early as week @ .", "sleep interference in all pregabalin groups was also significantly improved at endpoint , compared with placebo ( p < @ ) , beginning at week @ ( p < @ ) .", "at study termination , patients in the @ ( p = @ ) and @ mg/day ( p = @ ) groups were more likely to report global improvement than were those in the placebo group .", "most aes were mild or moderate .", "among pregabalin-treated patients , @ % withdrew due to aes , most commonly for dizziness ( @ patients , @ % ) , somnolence ( @ , @ % ) , or ataxia ( @ , @ % ) .", "pregabalin , dosed bid , reduced neuropathic pain associated with phn and was well tolerated .", "it also reduced the extent to which pain interfered with sleep .", "pregabalin 's effects were seen as early as week @ and were sustained throughout the @-week study ." ]

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

[ "to determine efficacy and safety of asoprisnil in patients with leiomyomata .", "phase @ , multicenter , prospective , randomized , double-blind , placebo-controlled , parallel-group study .", "twenty-eight sites in the united states and @ in canada .", "one hundred twenty-nine women with leiomyomata .", "asoprisnil ( @ , @ , or @ mg ) or placebo orally daily for @ weeks .", "uterine bleeding changes by using daily bleeding diaries , hemoglobin concentrations , dominant leiomyoma and uterus volume measured sonographically , patient-reported symptoms related to bloating and pelvic pressure , endometrial thickness and morphology , hormonal parameters , and standard safety measures .", "asoprisnil suppressed uterine bleeding in @ % , @ % , and @ % of subjects at @ , @ , and @ mg , respectively , and reduced leiomyoma and uterine volumes .", "median percentage decrease from baseline in leiomyoma volume was statistically significant at @ mg compared with placebo after @ and @ weeks of treatment ; by week @ , leiomyoma volume was reduced by @ % .", "there was a significant reduction in bloating with the two highest doses and in pelvic pressure with @ mg by week @ .", "asoprisnil was associated with follicular-phase estrogen concentration and minimal hypoestrogenic symptoms .", "after @-week treatment , asoprisnil controlled uterine bleeding while reducing leiomyoma volume and the associated pressure symptoms .", "asoprisnil was well tolerated ." ]

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

[ "this study examined whether pioglitazone , an agonist of peroxisome proliferator-activated receptor gamma , may stabilize vulnerable plaque with use of ultrasound evaluation of carotid artery plaque echolucency in patients with acute coronary syndrome ( acs ) and type @ diabetes mellitus ( dm ) .", "treatment with pioglitazone ( @ or @mg/day , n = @ ) or placebo ( n = @ ) was randomly assigned and initiated within @ days after the onset of acs in @ patients with type @ dm and echolucent carotid plaques .", "vulnerable carotid plaques were assessed by measuring plaque echolucency using carotid ultrasound with integrated backscatter ( ibs ) before , at @ weeks , and @ month and @ months after initiation of treatment .", "an increase in ibs value reflects an increase in carotid plaque echogenicity .", "calibrated ibs value ( intima-media ibs value minus adventitia ibs value ) of echolucent carotid plaques did not change at @ weeks but was significantly increased at @ month after treatment in the pioglitazone group but not in the placebo group .", "the increase in calibrated ibs value was not significantly correlated with the effect of pioglitazone on glycemia .", "pioglitazone rapidly improved carotid plaque echolucency within @ month of therapy initiation in patients with acs and type @ dm ." ]

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

[ "to evaluate the effectiveness of infant massage compared with that of a crib vibrator in the treatment of infantile colic .", "infants < @ weeks of age and perceived as colicky by their parents were randomly assigned to an infant massage group ( n = @ ) or a crib vibrator group ( n = @ ) .", "three daily intervention periods were recommended in both groups .", "parents recorded infant crying and given interventions in a structured cry diary that was kept for @ week before ( baseline ) and for @ weeks during the intervention .", "parents were interviewed after the first and third weeks of intervention to obtain their evaluation of the effectiveness of the given massage or crib vibration .", "at baseline , the mean amount of total crying was @ ( standard deviation : @ ) hours/day in the massage group infants and @ ( @ ) hours/day in the vibrator group infants .", "the mean amount of colicky crying was @ ( standard deviation : @ ) hours/day and @ ( @ ) hours/day , respectively .", "the mean number of daily intervention periods was @ in both groups .", "over the @-week study , the amount of total and colicky crying decreased significantly in both intervention groups .", "the reduction in crying was similar in the study groups : total crying decreased by a mean @ % in the massage group and by @ % in the vibrator group , and colicky crying decreased by @ % and @ % , respectively .", "the amount of other crying ( total crying minus colicky crying ) remained stable in both groups over the intervention .", "ninety-three percent of the parents in both groups reported that colic symptoms decreased over the @-week intervention , and @ % of the parents in the massage group and @ % of the parents in the crib vibrator group perceived the @-week intervention as colic reducing .", "infant massage was comparable to the use of a crib vibrator in reducing crying in colicky infants .", "we suggest that the decrease of total and colicky crying in the present study reflects more the natural course of early infant crying and colic than a specific effect of the interventions ." ]

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

[ "hypofractionated radiotherapy potentially offers therapeutic gain for prostate cancer .", "we investigated the feasibility of hypofractionated proton therapy ( pt ) .", "eighty-two patients with biopsy-proven t@-@n@m@ prostate adenocarcinoma and no history of androgen deprivation therapy were randomly assigned to five different dose schedules : arm @ , @ cge ( cobalt gray equivalent = proton dose in gy @ ) / @ fractions/@ weeks ; arm @ , @ cge/@ fractions/@ weeks ; arm @ , @ cge/@ fractions/@ weeks ; arm @ , @ cge/@ fractions/@ @ weeks ; or arm @ , @ cge/@ fractions/@ weeks .", "the median follow-up duration was @ months ( @-@ months ) .", "the acute gi and gu grade @ toxicity rates were @ and @ % , respectively .", "the late gi and gu grade @ toxicity rates were @ % and @ % , respectively .", "the best arm for acute gu toxicity was arm @ , while that for late gi toxicity was arm @ in which none had grade @ toxicity .", "the four-year american society for therapeutic radiology and oncology and nadir + @ng/ml bcf free survival ( bcffs ) rates were @ % and @ % , respectively .", "hypofractionated pt for patients with prostate adenocarcinoma as used in this study is feasible with an acceptable toxicity profile .", "as the bcffs rates do not seem to be inferior to those produced using conventional fractionation , the application of hypofractionated pt may save patients time and money ." ]

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

[ "our purpose was to investigate the effects of acupressure on sleep quality in hemodialysis patients .", "randomized clinical trial .", "the setting of the study was dialysis wards located in two university hospitals ( imam and golestan ) in ahvaz , iran .", "@ end-stage renal disease patients on hemodialysis who scored @ points or higher on the pittsburgh sleep quality index ( psqi ) were enrolled to the study .", "acupressure group received acupressure intervention on the shenmen ( he@ ) and he gu ( li@ ) points in the hands and sanyingjao ( sp@ ) point in the feet for @ weeks beside routine care and control group received only routine care .", "subjective sleep quality , latency and duration , habitual sleep efficiency ; sleep disturbances , daytime functional status , and use of sleeping medications .", "the result indicated significant differences between the acupressure group and the control group after intervention in psqi global scores ( p < @ ) and all sleep quality indices between two groups after intervention : subjective sleep quality ( p < @ ) , sleep latency ( p < @ ) , sleep duration ( p < @ ) , sleep efficiency ( p = @ ) , sleep disturbance ( p < @ ) , the use of sleeping medication ( p = @ ) , and daytime dysfunction ( p < @ ) .", "this study supports the effectiveness of acupressure in improving sleep quality of end-stage renal disease patients as a noninvasive therapy ." ]

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

[ "in fixed-dose studies , vardenafil @ , @ , and @mg improves erectile function in men with erectile dysfunction ( ed ) .", "here , the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed .", "in this multicenter trial , @ patients randomly received vardenafil @mg or placebo .", "after @ weeks , patients could switch to @ or @mg ( or corresponding placebo ) , or remain on @mg for an additional @ weeks ; dose-switching was optional for the last @ weeks .", "efficacy variables included the iief-ef domain score , gaq , and percentage of positive responses to sep@/sep@ questions .", "the iief-ef domain score significantly improved from a baseline of moderate ed ( @-@ @ ) to mild ed in men on vardenafil ( @-@ @ ) compared with placebo ( @-@ @ ) at weeks @ , @ , @ , and last observation carried forward ( locf ) ( p < @ vs. placebo ) .", "a significantly greater proportion of men receiving vardenafil at weeks @ , @ , @ , and locf reported improved erections ( @-@ % vs. @-@ % for placebo , p < @ ) .", "successful sep@ rates increased after vardenafil , reaching @ % at weeks @ and @ vs. @-@ % receiving placebo ( p < @ vs. placebo ) .", "vardenafil improved successful sep@ rates ranging from @ % to @ % compared to @-@ % for placebo .", "the most common adverse events , flushing and headache , were generally mild and transient .", "in this flexible dose study , vardenafil was well-tolerated , and produced clinically relevant improvements in erectile function in men with ed ." ]

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

[ "ketamine has been claimed to prevent acute opioid tolerance and hyperalgesia following acute exposure to opioids and its use has been proposed to decrease postoperative morphine consumption .", "we conducted a randomized , double-blind , controlled study to evaluate the effect of intravenous ( i.v. ) ketamine on postoperative pain for @ h after major ear , nose and throat ( ent ) surgery .", "thirty-one patients received i.v. ketamine @ mg kg ( -@ ) before induction and @ microg kg ( -@ ) min ( -@ ) during anaesthesia , and @ patients were administered placebo in a similar manner .", "anaesthesia was standardized with remifentanil and propofol , but without nitrous oxide .", "standardized postoperative analgesia included paracetamol , methylprednisolone and morphine administered via a patient controlled analgesia ( pca ) device .", "intra-operative remifentanil consumption was not different between the ketamine group ( @ + / - @ microg kg ( -@ ) min ( -@ ) ) and the control group ( @ + / - @ microg kg ( -@ ) min ( -@ ) ) .", "in the postoperative period , both groups experienced an identical pain course evolution .", "cumulative morphine consumption was not significantly different between groups : at @ h it was @ + / - @ with ketamine and @ + / - @ mg in controls , at @h it was @ + / - @ mg with ketamine and @ + / - @ mg in controls .", "low-dose ketamine added to a remifentanil-based propofol anaesthesia did not reduce morphine consumption after major ent surgery ." ]

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

[ "the resin-based pit and fissure sealant is considered a successful tool in caries prevention , however there is a growing evidence of its use in controlling already established caries in posterior teeth .", "the aim of this clinical trial is to verify the efficacy of pit and fissure sealants in arresting dentinal caries lesions compared to partial excavation and restorative treatment in primary molar teeth .", "thirty six patients with occlusal cavitated primary molar reaching outer half of dentin were selected .", "the patients were randomly allocated into two groups : sealant application ( experimental group - n = @ ) and restoration with composite resin ( control group - n = @ ) .", "clinical and radiograph evaluation were performed after @ , @ and @ months .", "the chi-square test was used to verify the distribution of characteristics variables of the sample among the groups .", "the survival rate of treatments was evaluated using kaplan-meier survival and log-rank test .", "fisher 's exact and logistic regression tests were calculated in each evaluation period ( = @ % ) .", "the control group showed significantly better clinical survival after @ months ( p = @ ) .", "in both groups , no caries progression was registered on the radiographic evaluations .", "sealing had similar efficacy in the arrestment of caries progression of cavitated occlusal lesions compared to partial excavation of the lesions , even though the frequency of re-treatments was significantly higher in sealed lesions .", "registro brasileiro de ensaios clnicos ( rebec ) : rbr-@kkv@ ." ]

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

[ "this study was conducted to compare oral contraceptive ( oc ) pharmacokinetics ( pk ) in normal-weight [ body mass index ( bmi ) @-@ @ ] and obese ( bmi @-@ @ ) women .", "during the third week of the third cycle of oc use , we admitted @ normal-weight and @ obese women for collection of @ venous specimens over @ h. using radioimmunoassay techniques , we measured levels of ethinyl estradiol ( ee ) and levonorgestrel ( lng ) .", "during the same cycle , women underwent twice-weekly sonography to assess ovarian follicular development and blood draws to measure endogenous estradiol ( e@ ) and progesterone levels .", "obese women had a lower area under the curve ( auc ; @ vs. @ pg * h/ml ) and lower maximum values ( @ vs. @ pg/ml ) for ee than normal-weight women ( p = @ and < @ , respectively ) ; ee trough levels were similar between bmi groups .", "the similar , but smaller , differences in their lng levels for auc and maximum values ( c ( max ) ) were not statistically significant .", "while peak values differed somewhat , the lng trough levels were similar for obese and normal-weight women ( @ and @ ng/ml , respectively ) .", "women with greater ee auc had smaller follicular diameters ( p = @ ) and lower e@ levels ( p = @ ) .", "while follicular diameters tended to be larger among obese women , these differences were not statistically significant .", "oc hormone peak levels are lower among obese women compared to normal-weight women , but their trough levels are similar .", "in this small study , the observed pk differences did not translate into more ovarian follicular activity among obese oc users ." ]

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

[ "the aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation ( abc ) treatment in liver resection .", "this trial was designed as an international , multicenter , randomized , controlled surgical trial with @ parallel groups .", "patients were eligible for intra-operative randomization after elective resection of @ liver segment and primary hemostasis .", "the primary end point was the time to hemostasis after starting the randomized intervention to obtain secondary hemostasis .", "secondary end points were drainage duration , volume , and content .", "adverse events were collected to evaluate the safety of treatments .", "the trial was registered internationally ( eudract number @-@-@ ) .", "among @ patients ( @ tachosil and @ abc ) randomized in @ tertiary care centers in europe , the mean time to hemostasis was less when tachosil was used ( @ minutes ) compared with abc ( @ minutes ; p = @ ) .", "the estimated ratio of mean time to hemostasis for tachosil/abc was @ ( @ % confidence interval , @-@ @ ; p = @ ) .", "postoperative drainage volume , drainage fluid , and drainage duration did not differ between the @ groups .", "mortality ( @ vs @ patients ) and adverse reactions ( @ vs @ patients ) for tachosil versus abc did not differ .", "this trial confirmed that tachosil achieved significantly faster hemostasis after liver resection compared with abc .", "postoperative morbidity and mortality remained unchanged between both groups ." ]

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

[ "the @-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients ' physical function over time .", "unfortunately , the reliability and sensitivity of this walk test are not well defined and , therefore , limit our ability to evaluate real changes in gait speed not attributable to normal variability .", "the aim of this study was to assess the test-restest reliability and sensitivity of the @-meter walk test , at a self-selected pace , among patients with mild to moderate knee osteoarthritis ( oa ) and to suggest a standardized protocol for future test administration .", "this was a measurement reliability study .", "fifteen consecutive people enrolled in a randomized-controlled trial of intra-articular corticosteroid injections for knee oa participated in this study .", "all participants completed @ trials on @ separate days , @ to @days apart ( @ trials total ) .", "each day was divided into @ sessions , which each involved @ walking trials .", "we compared walk times between trials with wilcoxon signed-rank tests .", "similar analyses compared average walk times between sessions .", "to confirm these analyses , we also calculated spearman correlation coefficients to assess the relationship between sessions .", "finally , smallest detectable differences ( sdd ) were calculated to estimate the sensitivity of the @-meter walk test .", "wilcoxon signed-rank tests between trials within the same session demonstrated that trials in session @ were significantly different and in the subsequent @ sessions , the median differences between trials were not significantly different .", "therefore , the first session of each day was considered a practice session , and the sdd between the second session of each day were calculated .", "sdd was -@ seconds ( walking slower ) and @ seconds ( walking faster ) .", "practice trials and a standardized protocol should be used in administration of the @-meter walk test .", "changes in walk time between -@ seconds ( walking slower ) and @ seconds ( walking faster ) should be considered within the range of normal variability of @-meter walking speed .", "the primary limitation of our study was a small sample size , which may influence the generalizability of our findings ." ]

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

[ "to evaluate and analyze mechanism of pizhen for the treatment of pain in patients with knee osteoarthritis .", "eighty-five patients ( @ knees ) were divided into two groups according to random number table method .", "among @ patients in the experimental group , @ patients were male and @ patients were female , @ patient lost follow-up , the average age was ( @ + / - @ ) years , and the patients were treated with pizhen .", "among @ patients in the control group , there were @ males and @ females , the average age was ( @ + / - @ ) years , and the patients were treated with intra-articular injection with sodium hyaluronate .", "the vas score and the data of algometer from the most obvious tenderness around the knee were used to evaluate the clinical effects .", "there were significant differences of scores in the experimental group before and after treatment ( p < @ ) .", "there were significant differences of scores in the control group before and after treatment ( p < @ ) .", "after treatment , there were no statistical differences of vas score and the data of algometer between experimental and control groups ( p > @ ) .", "there was negative correlation between vas score and the data of algometer .", "the pizhen is an effective method to treat pain in patients with knee osteoarthritis by relaxing tendon of soft tissue around pain point of knee joint , and relaxing compress and stimulation of nerves ." ]

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

[ "patients with an acute exacerbation of chronic obstructive pulmonary disease ( copd ) were randomised to either hospital at home ( hah ) or inpatient management , and patient and carer preferred site of management and satisfaction with care received in the two arms was determined .", "emergency admissions with an acute exacerbation of copd were randomised to inpatient care or hah care .", "after discharge an independent observer administered a questionnaire to both patients and carers on the preferred site of care and scored satisfaction with the care received .", "of @ patients recruited , @ were randomised to receive hah care .", "retrospective patient preference for hah care was @ % in the domiciliary arm and @ % in the conventional arm ; carer preference figures were @ % and @ % , respectively .", "there was a higher preference for domiciliary care by both patients and carers in the hah arm than in the inpatient arm ( p = @ and p = @ , respectively ) .", "patients recorded equal satisfaction with care in the two arms ( @ % in the conventional arm , @ % in the domiciliary arm ) ; carer scores were @ % and @ % , respectively .", "the results of this study show that both patients and carers were significantly more likely to prefer domiciliary care if they were in the hah arm .", "since patients had to be willing to be looked after at home , both patients ' and carers ' perceptions of the benefits of hah care were reinforced by their experience .", "hah care of acute exacerbations of copd is the preferred option in suitable patients ." ]

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

[ "activated granulocytes and monocytes may contribute to the pathogenesis of crohn 's disease ( cd ) .", "in small , uncontrolled studies , granulocyte/monocyte apheresis ( gma ) has shown promise in treating cd .", "we conducted a randomised , double-blind study to compare gma with a sham procedure in patients with moderate to severe cd .", "patients with active cd as defined by a crohn 's disease activity index ( cdai ) of @-@ were randomly allocated in a @:@ ratio to treatment with gma using the adacolumn apheresis system ( jimro , takasaki , japan ) or sham apheresis .", "ten apheresis sessions were scheduled over a @-week period , and efficacy was evaluated at week @ .", "the primary end point was the proportion of patients achieving clinical remission ( cdai score @ without use of prohibited drugs ) .", "clinical remission was achieved by @ % of patients in the gma group ( n = @ ) compared with @ % of those in the sham control group ( n = @ ) ( absolute difference -- @ % ( @ % ci -- @ % to @ % ) , p = @ ) .", "clinical response ( defined as a @-point decrease in cdai ) was achieved by @ % and @ % of patients in the gma and sham groups , respectively ( p = @ ) .", "the two treatments produced similar changes from baseline in cdai and quality of life , as well as in disease severity assessed endoscopically .", "the incidence and types of adverse events did not differ between groups .", "gma was well tolerated , but this study did not demonstrate its effectiveness over a sham procedure in inducing clinical remission or response in patients with moderate to severe cd ." ]