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pubmed_rct_200k

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

[ "review the prevalence , echocardiographic features and potential predictors of iatrogenic asd ( iasd ) created with the mitraclip guiding catheter .", "catheter-based repair of mitral regurgitation ( mr ) with the mitraclip device ( abbott vascular , menlo park , ca ) , is performed through a @-french transseptal guiding catheter .", "the echocardiographic prevalence of iasds after the mitraclip procedure has not been reported .", "thirty subjects undergoing mitraclip repair during the roll-in phase of the everest ii randomized trial who had baseline , @ day , @ and @ month transthoracic echocardiograms ( ttes ) available for review were included .", "patients who underwent surgery for mr within the first @ months were excluded .", "residual iasd size , right ventricular ( rv ) size , left atrial ( la ) volume , and tricuspid/mr grade were quantified .", "iasds were found at @ months in @ patients ( @ % ) with a mean diameter of @ @ mm .", "subjects with iasd at @ months had more residual mr , increased tr and a trend toward larger la volumes than non-iasd patients .", "@ % of non-asd patients were free from mr > @ + at @ mos .", "vs. @ % of those with iasd ( p = @ ) .", "there were no other significant associations between clinical and echocardiographic variables and the persistence of iasd .", "after mitraclip repair , persistent iasds occur at a rate comparable to reports after other transseptal interventional procedures and do not appear hemodynamically significant .", "patients with persistent iasds had less mr reduction at @-months and a trend toward larger la volumes , suggesting that increased la pressure may be a mechanism for persistent iasd ." ]

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

[ "the objectives of this double-blind study were to assess the tolerability and i.v. tyramine pressor response during combined treatment with moclobemide and selegiline .", "two parallel groups of @ healthy male and female subjects were treated with @ mg moclobemide or @ mg selegiline b.d. for @ days .", "on day @ , selegiline or moclobemide was added to the other treatment .", "iv tyramine pressor tests were conducted at baseline and at steady state during mono - and combined treatment .", "treatment with moclobemide and selegiline alone was well tolerated , whereas combined treatment led to a slight increase in adverse events .", "tyramine pressor sensitivity during moclobemide , selegiline and moclobemide + selegiline treatment was enhanced , on average , by @ - , @ - and @-times , respectively .", "although combined treatment with moclobemide and selegiline was well tolerated , the supra-additive potentiation of the tyramine pressor effects means that dietary restriction of tyramine intake will be necessary during such combination therapy ." ]

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

[ "to explore the effects of different anesthesia methods on the cellular immune function and mean arterial pressure , heart rate in patients with abdominal tumor in the peri-operational period .", "patients were anesthetized by general anesthesia ( ga ) , combined acupuncture-general anesthesia ( aga ) , combined epidural-general anesthesia ( ega ) , and combined acupuncture-epidural-general anesthesia ( aea ) , respectively .", "changes of t lymphocyte subsets and hemodynamics were observed at different time points before and after treatment .", "patients ' cellular immune function after ga was lowered , which could be alleviated by combination of ga with acupuncture anesthesia ( aa ) or with epidural anesthesia .", "combined acupuncture-drug anesthesia showed a stabilizing effect on hemodynamics in peri-operational period to some extent .", "ega and aga are good anesthesia choice in clinical practice , which would be favorable for early recovery of immune function in patients with abdominal tumor after operation ." ]

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

[ "to compare intraocular pressure ( iop ) measured by a goldmann applanation tonometer ( gat ) , a noncontact tonometer ( nct ) , and a portable noncontact tonometer ( pnct ) in eyes of healthy volunteers , and to determine if a significant correlation exists between the iop and the central corneal thickness ( cct ) .", "a total of @ healthy participants were randomly assigned to one of two groups ; in the first group , iop was measured first with the nct and then with the gat .", "in the second group , iop was measured first with the pnct and then with the gat .", "subsequently , the cct of all subjects was measured with an ultrasonic pachymeter .", "the iops determined by the gat and nct and were strongly correlated , as were those determined by the gat and pnct , in both groups .", "however , a bland-altman plot showed that the correlations between the gat and nct and between the gat and the pnct measurements were not significant .", "with all three instruments , the iop readings varied with the cct .", "the mean iops obtained with the gat increased by @ mmhg with each @-microm increase in cct ( @ mmhg/@ microm ) .", "the comparable value for the nct was @ mmhg/@ microm , and that for the pnct was @ mmhg/@ microm .", "for measurements of iop in normal eyes , the gat is the tonometer least affected by the cct , compared with the pnct and nct .", "a pnct is more likely to be affected by variations in cct than the gat ." ]

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

[ "to explore the role of gastro-pulmonary infection route in the development of ventilator-associated pneumonia ( vap ) , so as to improve the management of vap .", "forty-three patients who received mechanical ventilation ( mv ) were enrolled in the study .", "intra-gastric contents were labeled with ( @ ) mtc-dtpa .", "randomized two-period crossover trial was employed to determine the radioactive level in the oropharyngeal and bronchial secretion when patients were in supine or semi-reclining position .", "gastric juice , oropharyngeal secretion and tracheal lavage fluid were collected for bacterial culture every other day .", "bronchoalveolar lavage fluid ( balf ) was harvested from those suspected of vap for quantitative bacterial culture .", "infrequent-restriction site amplification ( irs-pcr ) was employed in the identification of the identity of the bacteria from intra-gastric colonization with those causing vap .", "the siga content in the balf was determined .", "the gastroesophageal regurgitation rate was higher ( @ % ) with lower aspiration rate ( @ % ) in patients receiving mv .", "moreover , the aspiration rate and the radioactivity of deep tracheal aspirates in patients in supine position were significantly higher than those in semi-reclining position ( p < @ ) .", "there was high homology of the bacteria isolated from intra-gastric colonization with that causing vap ( @ % ) .", "the siga content in balf in vap patients was evidently lower than that in non-vap patients ( p < @ ) .", "regurgitation and aspiration of stomach contents are very common in patients receiving mv .", "intra-gastric colonized bacteria might be one of the important origins causing vap .", "the lowering of siga in balf in patients with mv could be a risk factor for vap ." ]

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

[ "to assess the efficacy , safety , tolerability and pharmacokinetics of bibf @ in patients with stage iiib/iv non-small-cell lung cancer ( nsclc ) .", "patients with locally advanced or metastatic relapsed nsclc in whom first - or second-line platinum-based chemotherapy failed were randomly allocated to daily @ mg bibf @ b.i.d. or @ mg bibf @ b.i.d. primary end points were progression-free survival ( pfs ) and objective tumour response ( recist ) .", "incidence and severity of adverse events ( aes ) were reported .", "seventy-three patients received bibf @ .", "median pfs was @ weeks , with no significant difference between treatment arms .", "median overall survival ( os ) was @ weeks .", "eastern cooperative oncology group ( ecog ) @-@ patients ( n = @ ) had a median pfs of @ weeks and a median os of @ weeks .", "tumour stabilisation was achieved in @ % of patients ( ecog @-@ patients : @ % ) , with one confirmed partial response ( @ mg b.i.d. ) .", "most commonly reported drug-related aes were nausea ( @ % ) , diarrhoea ( @ % ) , vomiting ( @ % ) , anorexia ( @ % ) , abdominal pain ( @ % ) and reversible alanine transaminase ( @ % ) and aspartate aminotransferase elevations ( @ % ) .", "bibf @ displayed dose-linear pharmacokinetic characteristics .", "continuous treatment with bibf @ was well tolerated , with no difference in efficacy between treatment arms .", "pfs and objective response with single-agent treatment in advanced disease warrants further exploration ." ]

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

[ "to compare the vascular responses to hormone therapy in women with and without hot flushes .", "we randomly assigned @ healthy , recently postmenopausal women ( mean age @ + / -@ years , time since menopause @ + / -@ months ) with intolerable hot flushes ( more than seven moderate/severe episodes per day ) or tolerable hot flushes ( fewer than three mild episodes per day ) to receive @ mg of transdermal estradiol gel , oral estradiol ( @ mg ) with and without daily medroxyprogesterone acetate , or placebo for @ months .", "vascular function was assessed by pulse-wave analysis and endothelial function testing with nitroglycerin and salbutamol challenges .", "hot flushes did not affect the changes in arterial or aortic stiffness or endothelial function in response to various forms of hormone therapy .", "however , in women with tolerable hot flushes , oral estradiol caused a decrease of @ % ( p = @ ) in the time to the first systolic peak ( dependent on the rapid phase of ventricular ejection ) after nitroglycerin .", "in addition , the time to the reflected wave ( dependent on pulse-wave velocity ) after nitroglycerin was decreased by @ % ( p = @ ) .", "these effects were not seen in women with intolerable hot flushes or with the other treatment regimens .", "women without troublesome hot flushes are susceptible to unfavorable vascular effects after oral estrogen treatment , resulting in less compliant vasculature .", "clinicaltrials.gov , www.clinicaltrials.gov , nct@ .", "i." ]

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

[ "to measure the analgesic effectiveness of the @ s 's ( swaddling , side/stomach position , shushing , swinging , and sucking ) alone and combined with sucrose , during routine immunizations at @ and @ months .", "we conducted a prospective , randomized , placebo-controlled trial with @ - and @-month-old infants during well-child visits .", "patients were assigned into @ groups ( @ @ ) receiving either @ ml of water or @ ml of @ % oral sucrose and then either standard-of-care comfort measures by parents or intervention with the @ s 's immediately postvaccination .", "the modified riley pain score was used to score the infants ' pain at @-second intervals for @ minutes , then every @ seconds up to @ minutes postvaccination .", "repeated-measures analysis of variance examined between group differences and within-subject variability of treatment effect on overall pain scores and length of crying .", "two hundred thirty infants were enrolled .", "results revealed significantly different mean pain scores between study groups with the exception of the @s 's and @s 's with sucrose groups .", "these @ groups had lower similar mean scores over time , followed by sucrose alone , then control .", "the same trend was found with the proportion of children crying as with the mean pain score outcome measure .", "physical intervention of the @ s 's ( swaddling , side/stomach position , shushing , swinging , and sucking ) provided decreased pain scores on a validated pain scale and decreased crying time among @ - and @-month-old infants during routine vaccinations .", "the use of @s 's did not differ from @s 's and sucrose ." ]

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

[ "to assess the feasibility of a randomised controlled trial ( rct ) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with fibromyalgia syndrome ( fms ) .", "in a pragmatic parallel group rct design , adults with a diagnosis of fms ( acr criteria ) were randomly allocated to usual care or usual care plus adjunctive care by a homeopath .", "adjunctive care consisted of five in depth interviews and individualised homeopathic medicines .", "the primary outcome measure was the difference in fibromyalgia impact questionnaire ( fiq ) total score at @ weeks .", "@ patients were recruited .", "drop out rate in the usual care group was higher than the homeopath care group ( @/@ vs @/@ ) .", "adjusted for baseline , there was a significantly greater mean reduction in the fiq total score ( function ) in the homeopath care group than the usual care group ( -@ vs @ ) .", "there were significantly greater reductions in the homeopath care group in the mcgill pain score , fiq fatigue and tiredness upon waking scores .", "we found a small effect on pain score ( @ , @ % ci -@ to @ ) ; but a large effect on function ( @ , @ % ci -@ to @ ) .", "there were no reported adverse events .", "given the acceptability of the treatment and the clinically relevant effect on function , there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with fms ." ]

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

[ "this study sought to evaluate the dose-dependent effects of adenosine a@-receptor blockade on diuresis and renal function in patients with acute decompensated heart failure ( adhf ) and renal impairment or diuretic resistance .", "intravenous loop diuretics are the mainstay of therapy for patients with adhf .", "treatment , however , may be complicated by diuretic resistance and/or worsening renal function .", "we carried out a pair of randomized , double-blind , placebo-controlled , proof-of-concept studies in @ clinically challenging adhf populations .", "in the adhf protocol , @ patients with volume overload and an estimated creatinine clearance ( crcl ) of @ to @ ml/min were randomized to placebo or @ of @ doses of kw-@ ( rolofylline ) infused over @ h daily for up to @ days .", "on day @ , kw-@ monotherapy increased urine output during the first @ h ( @ , @ , @ , and @ ml in the @ - , @ - , @ - , and @-mg groups , respectively ) compared with placebo ( @ ml ; p = @ ) .", "on day @ , serum creatinine decreased in all kw-@ groups and increased with placebo ( p = @ ) .", "by day @ or day of discharge if earlier , intravenous furosemide administration tended to be lower in the kw-@ groups compared with placebo ( p = @ ) .", "in the diuretic-resistant protocol , @ patients with an average crcl of @ ml/min were randomized to a single infusion of placebo , @ , @ , or @ mg of kw-@ .", "compared with placebo , kw-@ increased hourly urine volume and estimated crcl with peak effects occurring at @ to @ h and at @ h , respectively .", "adverse events were not different between placebo and kw-@ .", "in patients with adhf and volume overload , kw-@ , an adenosine a@-receptor antagonist , enhances the response to loop diuretics and may have a renal protective effect ." ]

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

[ "to evaluate bimatoprost versus latanoprost and timolol fixed combination ( ltfc ) over the @-hour diurnal curve in patients who switched from timolol .", "in this prospective , observer-masked , randomized clinical trial , @ patients whose intraocular pressures ( iops ) were not effectively controlled with timolol were enrolled .", "at pretrial visit iops and central corneal thickness were measured .", "after the baseline visit , timolol was replaced by bimatoprost or ltfc .", "iops were recorded at @ am , noon , @ pm , @ pm , midnight , and @ am at baseline , week @ , and week @ visits .", "at baseline and week @ visits , there was no significant difference between the ltfc and bimatoprost group for the mean iops at @ time points in @ hours , the mean diurnal iop , and range of diurnal iop .", "at week @ , the mean iop of the bimatoprost group ( @ mm hg ) at @ am and @ o ' clock , midnight , was statistically significantly lower than that of the ltfc group ( @ and @ mm hg ; p = @ and @ ) .", "a statistically significant difference was not found between the proportions of patients who had @ % and @ % decrease in mean diurnal iop and the mean daytime , nighttime , diurnal iop reductions of the @ study groups at weeks @ and @ ( p > @ ) .", "in the bimatoprost group punctate epitheliopathy , conjunctival hyperemia , and lid erythema were found to be more frequent .", "the ltfc and bimatoprost therapies were equally effective in maintaining iop at lower levels during the @-hour period in patients who switched from timolol therapy .", "adverse events were more frequent with bimatoprost therapy ." ]

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

[ "to assess the impact of the development of high - or low-affinity insulin antibodies ( iabs ) on postprandial glucose tolerance , duration of insulin action , and clinical safety in patients with type @ diabetes receiving inhaled insulin ( exubera ) .", "this study consisted of a prospective , randomized , open-label , parallel-group trial in which @ patients with type @ diabetes received nph insulin twice daily plus either premeal inhaled insulin ( inh group ; n = @ ) or pre-meal subcutaneous regular insulin ( sc group ; n = @ ) for @ weeks .", "meal challenge and euglycemic clamp studies were performed on consecutive days at baseline , week @ , and week @ .", "adverse events were monitored .", "for the inh and sc groups , mean ( + / - sd ) iab levels were @ + / - @ and @ + / - @ muu/ml at baseline , respectively , compared with @ + / - @ and @ + / - @ microu/ml at week @ .", "at week @ , the changes from baseline were similar for the inh and sc groups for maximal plasma glucose concentration ( c ( max ) ) ( adjusted ratio for treatment group difference @ [ @ % ci @-@ @ ] ) , area under the plasma glucose concentration time curve ( adjusted ratio for treatment group difference @ [ @-@ @ ] ) , and duration of insulin action ( adjusted treatment group difference @ min [ -@ to @ ] ) .", "no adverse events were attributed to iabs .", "in patients with type @ diabetes treated with inhaled insulin , development of high - or low-affinity iabs did not impair postprandial glucose tolerance , alter the time-action profile of insulin , or impact tolerability .", "no clinical relevance of iabs was identified in this study ." ]

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

[ "to estimate the effect of state medicaid nursing home reimbursement rates on hospitalizations of nursing home residents .", "cross-sectional sample of nongovernment-owned nursing homes with @ beds or more in one metropolitan statistical area in each of @ states in @ , with @ months follow-up on mortality and hospitalizations .", "two hundred fifty-three nursing homes .", "eight to @ randomly selected residents from each facility , totaling @,@ .", "minimum data set assessments conducted by research nurses at baseline .", "a three-category @-month outcome was defined as ( @ ) any hospitalization ; for those not hospitalized , ( @ ) death versus ( @ ) alive in the facility .", "using multinomial logistic regression , adjusted to survey design , controlling for resident and facility characteristics , a @ dollar increase in @ medicaid reimbursement rate above the mean rate of approximately @ dollars resulted in a @ % reduction in a resident 's risk of hospitalization ( p < @ ) .", "state medicaid reimbursement rates appear to affect clinical decisions regarding the need for hospital admission and thresholds for nursing home use .", "the findings from this study reemphasize the importance of properly aligning state medicaid and federal medicare long-term care policies because , currently , states have no incentive to increase reimbursement rates to avoid hospitalization ." ]

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

[ "to determine whether the addition of aminoglutethimide to tamoxifen is able to improve the outcome in postmenopausal patients with hormone receptor-positive , early-stage breast cancer .", "a total of @,@ postmenopausal women were randomly assigned to receive either tamoxifen for @ years alone or tamoxifen in combination with aminoglutethimide ( @ mg/d ) for the first @ years of treatment .", "tamoxifen was administered at @ mg/d for the first @ years and at @ mg/d for @ years .", "all randomized and eligible patients were included in the analysis according to the intention-to-treat principle .", "after a median follow-up of @ years , the @-year disease-free survival in the aminoglutethimide plus tamoxifen group was @ % versus @ % in the monotherapy group ( p = @ ) .", "the corresponding data for overall survival at @ years were @ % and @ % , respectively ( p = @ ) .", "more patients failed to complete combination treatment ( @ % ) because of side effects as compared to tamoxifen alone ( @ % ; p = @ ) .", "aminoglutethimide given for @ years in addition to tamoxifen for @ years does not improve the prognosis of postmenopausal patients with receptor-positive , lymph node-negative or lymph node-positive breast cancer ." ]

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

[ "to assess the rate of r ( @ ) resection of liver metastases achieved after chemotherapy with folfirinox .", "patients with histologically proven primary colorectal cancer and bidimensionally measurable liver metastasis , not fully resectable based on technical inability to achieve r ( @ ) resection , but potentially resectable after tumor reduction , were given folfirinox : oxaliplatin @ mg/m ( @ ) , irinotecan @ mg/m ( @ ) , leucovorin @ mg/m ( @ ) , bolus fluorouracil @ mg/m ( @ ) and fluorouracil @-h continuous iv infusion @,@ mg/m ( @ ) , every @ weeks for a maximum of @ cycles .", "thirty-four patients were enrolled .", "response rate before surgery was @ % ( @ % ci : @-@ @ ) .", "twenty-eight patients ( @ % ) underwent hepatic resection and nine achieved r ( @ ) resection [ @ % ( @ % ci : @-@ @ % ) ] .", "the rate of clinical complete remission after surgery was @ % .", "two-year overall survival was @ % .", "the most frequent grade @ or @ toxicities were neutropenia ( @ % ) , diarrhea ( @ % ) , fatigue ( @ % ) , abdominal cramps ( @ % ) , neuropathy and nausea ( @ % each ) , and ast/alt elevation ( @ / @ % ) .", "only one patient experienced febrile neutropenia , four patients withdrew due to toxicity and no toxic death was observed .", "folfirinox , with an acceptable toxicity profile , shows a high response rate in liver metastases from colorectal cancer .", "the rate of hepatic resection in patients initially not resectable , is attractive and warrants further assessment of this regimen in randomized studies compared to standard regimens ." ]

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

[ "to compare the effects of inhaled nitric oxide and aerosolized prostacyclin ( pgi@ ) on hemodynamics and gas exchange as well as on the indocyanine-green plasma disappearance rate and gastric intramucosal ph in patients with septic shock .", "prospective , randomized , interventional clinical study .", "intensive care unit in a university hospital .", "sixteen patients with pulmonary hypertension and septic shock according to the criteria of the accp/sccm consensus conference all requiring norepinephrine and/or epinephrine to maintain mean arterial blood pressure above @ mmhg .", "patients were randomly assigned to receive either nitric oxide or aerosolized prostacyclin .", "nitric oxide was inhaled using a commercially available delivery system , prostacyclin was administered with a modified ultrasound nebulizer .", "both nitric oxide and prostacyclin were incrementally adjusted to obtain a @ % decrease of mean pulmonary artery pressure .", "hemodynamics and gas exchange as well as indocyanine-green plasma disappearance rate and gastric intramucosal ph were determined at baseline after @ min in steady state , after @ min of nitric oxide inhalation or prostacyclin aerosol administration had elapsed in stable conditions , and after @ min in stable conditions after nitric oxide or prostacyclin withdrawal .", "both inhaled nitric oxide and aerosolized prostacyclin selectively reduced the mean pulmonary artery pressure from @ + / - @ , @ + / - @ mmhg ( p < @ ) and @ + / - @ to @ + / - @ mmhg ( p < @ ) respectively ; after removal of nitric oxide and prostacyclin , the mean pulmonary artery pressure returned to the baseline values .", "systemic hemodynamics remained unaltered during the vasodilator treatment .", "while the mean pao@ was not significantly influenced , it increased in @/@ of the no - and @/@ of the pgi@-treated patients .", "neither of the drugs influenced indocyanine-green plasma disappearance rate , but prostacyclin -- unlike nitric oxide -- significantly increased gastric intramucosal ph ( from @ + / - @ to @ + / - @ , p < @ ) which remained elevated in four of these patients after prostacyclin removal , and decreased the arterial-gastric mucosal pressure of carbon dioxide gap from @ + / - @ to @ + / - @ mmhg ( p < @ ) .", "our data suggest that aerosolized prostacyclin -- unlike nitric oxide -- has similar beneficial effects on splanchnic perfusion and oxygenation as intravenous prostacyclin without detrimental effects on systemic hemodynamics .", "the different effects of prostacyclin and nitric oxide might be explained by the longer half-life of prostacyclin associated with a certain spillover into the systemic circulation ." ]

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

[ "a prospective , randomized clinical trial to assess the effect of reducing the volume of irradiated normal tissue on acute reactions in pelvic radiotherapy accured @ evaluable patients between @ and @ .", "this is the definitive analysis to assess the differences between the conformal and conventional arms of the trial .", "in both arms , patients were treated with @ mv x-rays using a @-field technique ( in all but @ cases ) consisting of an anterior and two wedged lateral or posterior oblique fields ; in the conventional arm , rectangular fields were employed , whereas in the conformal arm , the fields were shaped with customized blocks drawn according to the beam 's - eye-view of the target volume .", "the most common dosage was @ gy in @-gy fractions @ times a week , although a subgroup ( of ca .", "bladder patients ) were treated with @-@ gy in once-a-week @ gy fractions .", "each patients completed a comprehensive acute toxicity scoring questionnaire concentrating on bowel and bladder problems , tiredness and nausea , before the start of treatment , weekly during and for @ weeks after the end of treatment and then monthly for a further @ months .", "compliance was excellent .", "there were no differences between the patients in the two arms with respect to age , gender , tumour type ( @ % prostate , @ % bladder , @ % rectum , @ % other ) fractionation/dosage , anterior field size , weight , or baseline symptoms .", "substantial differences in normal-tissue volumes ( rectum , bladder , etc. ) were achieved : median high-dose volume ( hdv ) of @ cm@ for the conformal technique versus @ cm@ for the conventional .", "a clear pattern of an increase in symptoms during rt , followed by a decrease after rt , was observed for the patient group as a whole .", "however , a very extensive analysis has not revealed any ( statistically ) significant differences between the two arms in level of symptoms , nor in medication prescribed .", "the disparity between our findings and those of other , non-randomized studies is discussed .", "the data on late effects must be collected and analyzed before any definite conclusions can be drawn on the benefits of conformal therapy in the pelvis ." ]

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

[ "tunneled-cuffed catheters ( tcc ) are often used among the elderly to commence and carry out haemodialysis ( hd ) .", "complications like infection and thrombosis frequently reduce the lifespan of tcc .", "the role of an antibiotic heparin ` lock ' in the prevention of thrombotic and infectious complications and enhancement of tcc survival in the elderly has not been investigated previously .", "in this prospective , double-blind clinical trial , tcc ( n = @ , placed among @ elderly patients requiring hd during march @ - february @ ) were randomised to either group i having tcc ( n = @ , placed in @ elderly patients ) locked with cefotaxime ( @ mg/ml ) and heparin ( @ u/ml ) , or group ii with tcc ( n = @ , placed in @ elderly patients ) having catheter-restricted filling of heparin ( @ u/ml ) alone .", "symptomatic catheter-related blood stream infections ( crbsi ) and catheter thrombosis were the primary end points in this study .", "thrombosis was defined as an inability to use the catheter at a blood flow of @ ml/min that did not respond to catheter repositioning and/or intraluminal thrombolysis .", "the incidence of catheter thrombosis , crbsi and percentage of catheter survival were estimated and statistically compared between the two groups .", "kaplan-meier survival analysis using log rank test showed higher thrombosis-free tcc survival ( @ % vs @ % , p = @ ) , infection-free survival ( @ % vs @ % , p < @ ) and infection and thrombosis-free survival ( @ % vs @ % , p = @ ) at @ days in group i compared with group ii .", "cefotaxime and heparin locks safely and effectively enhance the lifespan of tcc by lowering the incidence of thrombotic and infectious complications among elderly end-stage renal failure ( esrd ) patients ." ]

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

[ "a long-term follow-up study with nuclear magnetic resonance ( nmr ) imaging was undertaken to detect the morphological onset and to establish the early diagnosis in apical hypertrophic cardiomyopathy ( hcm ) .", "a spadelike configuration on left ventriculogram ( lvg ) is regarded as a diagnostic criterion for the classical apical hcm .", "there also exists a segmented hypertrophy at the apical level without indicating the spadelike features ( a nonspade configuration ) .", "to detect the hypertrophied myocardium of the nonspade configuration , circumferential scrutiny of the apex is required .", "although both configurations can be underlying causes of giant negative t waves , etiological relationship between the two is not clarified .", "the criteria for the spadelike configuration defined on left ventricular short-axis nmr images were as follows : ( apical maximal thickness > or = @ mm ) , ( apical anterior thickness over basal anterior thickness > or = @ ) and ( apical posterior thickness over basal posterior thickness > or = @ ) .", "thirteen patients who had predominant hypertrophy ( > or = @ mm ) at the apical level without the spadelike configuration underwent nmr imaging twice before and after @ + / -@ months ' follow-up .", "apical hypertrophy that had been confined to the lateral wall in four , the anterior-lateral wall in two , and the septal-anterior wall in one developed to become circumferential hypertrophy that fulfilled the criteria for the spadelike configuration after the follow-up period .", "the spadelike configuration can begin with the nonspade configuration and therefore , both can constitute a single disease entity of apical hcm .", "the early diagnosis of apical hcm can be achieved by identifying the hypertrophy frequently confined to the lateral wall at the apical level ." ]

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

[ "to determine efficacy of midazolam as a sedative in mechanically ventilated newborns .", "double blind randomized placebo controlled trial .", "neonatal unit of tertiary hospital .", "sedation over @ h of observation .", "neonates with birth weight less than @ g who were mechanically ventilated within @ days of life were randomly assigned to midazolam and placebo group .", "midazolam and placebo were administered as bolus ( @ mg/kg ) followed by continuous infusion ( @ mg/kg/h ) .", "both groups received morphine infusion ( @ microg/kg/h ) .", "sedation score was noted at @ hourly intervals for @ hours .", "hemodynamic variables , ventilatory variables , complications and side effects of treatments were also recorded .", "thirty-three neonates were enrolled ( @ in midazolam , @ in placebo group ) .", "the groups were comparable for birth weights and gestation .", "the midazolam group had significantly better sedation from @-@ hours after enrollment compared to placebo group .", "at @ h there were no significant differences in proportion of infants with adequate sedation between midazolam and placebo group .", "the two groups were comparable with respect to heart rate , perfusion , ventilatory indices and blood gas parameters .", "none of the infants were noted to have hypotension on loading with midazolam or placebo .", "seizures were noted in @ neonates in placebo group @ hours after enrollment ( insignificant statistically ) .", "sedation provided by continuous infusion of midazolam and morphine appears to be comparable to morphine alone in newborn babies on mechanical ventilation , with no significant adverse effects .", "the course of mechanical ventilation is not influenced by use of midazolam ." ]

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

[ "to analyze different events that determine event-free survival ( efs ) in a randomized trial on adjuvant radiotherapy in early breast cancer patients with more than @ years of follow-up evaluation .", "the trial included @ patients with a unilateral , operable breast cancer .", "surgery consisted of a modified radical mastectomy .", "the trial compared three arms , as follows : preoperative radiotherapy , postoperative radiotherapy , and no adjuvant treatment .", "events were analyzed by a competing-risk approach .", "a proportional hazards multiple regression model was used to analyze the effects of radiotherapy on the risk of distant metastasis .", "similar analyses were performed separately for node-negative [ n ( - ) ] and node-positive [ n ( + ) ] patients in the two groups that did not include preoperative radiotherapy .", "radiotherapy produced a fivefold decrease of the risk of local recurrence ( p < @ ) .", "in n ( + ) patients , postoperative radiotherapy decreased the risk of distant dissemination ( relative risk , @ ) .", "when local recurrence was introduced in the model as a time-dependent covariate , this factor was predictive of distant dissemination ( p < @ ) and nullified the effect of postoperative radiotherapy .", "this finding suggests that the decrease of distant metastases was related to the prevention of local recurrence .", "a similar effect was found in models that used overall survival as an end point .", "this study shows that postmastectomy radiotherapy in n ( + ) breast cancer patients may decrease the distant metastasis rate by preventing local recurrences and thus avoiding secondary dissemination ." ]

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

[ "mesorectal excision is the international standard surgical procedure for lower rectal cancer .", "however , lateral pelvic lymph node metastasis occasionally occurs in patients with clinical stage ii or stage iii rectal cancer , and therefore mesorectal excision with lateral lymph node dissection is the standard procedure in japan .", "we did a randomised controlled trial to confirm that the results of mesorectal excision alone are not inferior to those of mesorectal excision with lateral lymph node dissection .", "this study was undertaken at @ major hospitals in japan .", "eligibility criteria included histologically proven rectal cancer of clinical stage ii or stage iii , with the main lesion located in the rectum with the lower margin below the peritoneal reflection , and no lateral pelvic lymph node enlargement .", "after surgeons had confirmed macroscopic r@ resection by mesorectal excision , patients were intraoperatively randomised to mesorectal excision alone or with lateral lymph node dissection .", "the groups were balanced by a minimisation method according to clinical n staging ( n@ or n@ , @ ) , sex , and institution .", "allocated procedure was not masked to investigators or patients .", "this study is now in the follow-up stage .", "the primary endpoint is relapse-free survival and will be reported after the primary analysis planned for @ .", "here , we compare operation time , blood loss , postoperative morbidity ( grade @ or @ ) , and hospital mortality between the two groups .", "analysis was by intention-to-treat .", "this trial is registered with clinicaltrials.gov , number nct@ .", "@ patients were randomly assigned to mesoretcal excision with lateral lymph node dissection and @ to mesorectal excision alone , between june @ , @ , and aug @ , @ .", "one patient in the mesorectal excision alone group underwent lateral lymph node dissection , but was analysed in their assigned group .", "operation time was significantly longer in the mesorectal excision with lateral lymph node dissection group ( median @ min , iqr @-@ ) than in the mesorectal excision alone group ( @ min , @-@ , p < @ ) .", "blood loss was significantly higher in the mesorectal excision with lateral lymph node dissection group ( @ ml , iqr @-@ ) than in the mesorectal excision alone group ( @ ml , @-@ ; p < @ ) .", "@ ( @ % ) patients in the mesorectal excision with lateral lymph node dissection group had lateral pelvic lymph node metastasis .", "grade @-@ postoperative complications occurred in @ ( @ % ) patients in the mesorectal excision with lateral lymph node dissection group and @ ( @ % ) patients in the mesorectal excision alone group .", "the most common grade @ or @ postoperative complication was anastomotic leakage ( @ [ @ % ] patients in the mesorectal excision with lateral lymph node dissection group vs @ [ @ % ] in the mesorectal excision alone group ; p = @ ) .", "one patient in the mesorectal excision with lateral lymph node dissection group died of anastomotic leakage followed by sepsis .", "mesorectal excision with lateral lymph node dissection required a significantly longer operation time and resulted in significantly greater blood loss than mesorectal excision alone .", "the primary analysis will help to show whether or not mesorectal excision alone is non-inferior to mesorectal excision with lateral lymph node dissection .", "national cancer center , ministry of health , labour and welfare of japan ." ]

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

[ "after measles vaccine ( mv ) , all-cause mortality is reduced more than can be explained by the prevention of measles , especially in females .", "we aimed to study the biological mechanisms underlying the observed non-specific and sex-differential effects of mv on mortality .", "within a large randomised trial of mv at @ months of age blood samples were obtained before and six weeks after randomisation to early mv or no early mv .", "we measured concentrations of cytokines and soluble receptors from plasma ( interleukin-@ receptor agonist ( il-@ra ) , il-@ , il-@ , il-@ , tumor necrosis factor ( tnf ) - , monocyte chemoattractant protein ( mcp ) -@ , soluble urokinase-type plasminogen activator receptor ) , and secreted cytokines ( interferon - , tnf - , il-@ , il-@ , il-@ , il-@ ) after in vitro challenge with innate agonists and recall antigens .", "we analysed the effect of mv in multiple imputation regression , overall and stratified by sex .", "the majority of the infants had previously been enrolled in a randomised trial of neonatal vitamin a. post hoc we explored the potential effect modification by neonatal vitamin a.", "overall , mv versus no mv was associated with higher plasma mcp-@ levels , but the effect was only significant among females .", "additionally , mv was associated with increased plasma il-@ra .", "mv had significantly positive effects on plasma il-@ra and il-@ levels in females , but not in males .", "these effects were strongest in vitamin a supplemented infants .", "vitamin a shifted the effect of mv in a pro-inflammatory direction .", "in this explorative study we found indications of sex-differential effects of mv on several of the plasma biomarkers investigated ; in particular mv increased levels in females , most strongly in vitamin a recipients .", "the findings support that sex and micronutrient supplementation should be taken into account when analysing vaccine effects .", "clinicaltrials.gov number nct @ ." ]

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

[ "this study compared the effects of a distributed form of constraint-induced therapy with control intervention in motor recovery and brain reorganization after stroke .", "a two-group randomized controlled trial with pretreatment and posttreatment measures was conducted .", "thirteen patients with stroke were randomly assigned to the distributed form of constraint-induced therapy ( n = @ ) or the control intervention group ( n = @ ) .", "outcome measures included the fugl-meyer assessment , the motor activity log , and functional magnetic resonance imaging examination .", "the number of activation voxels and laterality index were determined from the functional magnetic resonance imaging data for the study of brain reorganization .", "the distributed form of constraint-induced therapy group exhibited significantly greater improvements in the fugl-meyer assessment and motor activity log than the control intervention group .", "the functional magnetic resonance imaging data showed that distributed form of constraint-induced therapy significantly increased activation in the contralesional hemisphere during movement of the affected and unaffected hand .", "the control intervention group showed a decrease in primary sensorimotor cortex activation of the ipsilesional hemisphere during movement of the affected hand .", "the preliminary findings indicate that brain adaptation may be modulated by specific rehabilitation practices , although generalization of the functional magnetic resonance imaging findings is limited by sample size .", "further research is needed to identify the specific neural correlates of the behavioral gains achieved after rehabilitation therapies ." ]

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

[ "this study evaluated the clinical and metabolic effects of full-mouth scaling and root planing ( fmsrp ) compared to partial-mouth scaling and root planing ( pmsrp ) in patients with type @ diabetes and chronic periodontitis , and it assessed the impact of the glycemic status on the clinical and metabolic response to periodontal therapy .", "in this clinical trial , @ subjects with diabetes received fmsrp in a maximum of @ hours , and @ subjects received pmsrp in a maximum of @ days .", "visible plaque accumulation , bleeding on probing , suppuration , probing depth , clinical attachment level ( cal ) , and glycosylated hemoglobin ( hba@c ) levels were obtained at baseline and at @ and @ months post-therapy .", "baseline hba@c values > or = @ % and < @ % defined subjects with poorly and better-controlled diabetes , respectively .", "all clinical parameters improved after therapy ( p < @ ) .", "no significant differences were observed between treatment groups for clinical and metabolic parameters at any time ( p > @ ) .", "there were no changes in the hba@c levels after therapy ( p > @ ) .", "no subject reported any adverse effects during the study .", "individuals with better-controlled diabetes achieved a lower mean cal at @ months post-therapy , when fmsrp and pmsrp were evaluated together ( p < @ ) .", "fmsrp and pmsrp were equally effective in treating chronic periodontitis in subjects with type @ diabetes , without significant improvements in the glycemic control at @ and @ months .", "considering the periodontal therapy as a whole ( fmsrp plus pmsrp ) , subjects with better-controlled diabetes exhibited a benefit in cal at @ months compared to subjects with poorly controlled disease ." ]

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

[ "this study was conducted to demonstrate the long-term efficacy of sodium oxybate for the long-term treatment of cataplexy in patients with narcolepsy .", "fifty-five ( @ ) narcoleptic patients with cataplexy who had received continuous treatment with sodium oxybate for @-@ months ( mean @ months ) were enrolled in a double-blind treatment withdrawal paradigm .", "a @-week single-blind sodium oxybate treatment phase established a baseline for the weekly occurrence of cataplexy .", "this was followed by a @-week double-blind phase in which patients were randomized to receive unchanged drug therapy or placebo .", "patients recorded the incidence of cataplexy attacks and adverse events in daily diaries .", "during the @-week double-blind phase , the abrupt cessation of sodium oxybate therapy in the placebo patients resulted in a significant increase in the number of cataplexy attacks ( median = @ ; p < @ ) compared to patients who remained on sodium oxybate ( median = @ ) .", "cataplexy attacks returned gradually with placebo patients reporting a median of @ and @ cataplexy attacks during the first and second weeks , respectively .", "there were no symptoms of frank withdrawal .", "this controlled trial provides evidence supporting the long-term efficacy of sodium oxybate for the treatment of cataplexy .", "in contrast with antidepressant drug therapy , there is no evidence of rebound cataplexy upon abrupt discontinuation of treatment ." ]

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

[ "management of functional dyspepsia is still controversial .", "different controlled trials reported a superiority of prokinetics , h@-receptor antagonists and proton-pump inhibitors over placebo ; nevertheless , symptomatic improvement after therapy is often incomplete and some of these drugs possess serious side effects .", "the aim of the study was to evaluate the efficacy of a new medical device in respect to domperidone in patients with functional dyspepsia .", "in a cross-over , randomized trial , @ patients with functional dyspepsia ingested two daily doses of a medical device ( digerfast ) or domperidone ( peridon ) for @ days .", "clinical evaluation was performed at baseline ( t@ ) and after @ days ( t@ ) for each treatment .", "a visual analogue scale ( vas ) and the generic scale @-item short form ( sf-@ ) were used to assess symptom intensity and changes in health-related quality of life , respectively .", "at t@ no statistical difference was found for each symptom between medical device and domperidone .", "at t@ both treatments significantly improved in respect to baseline values all the evaluated gastrointestinal symptoms ( p < @ for all comparisons ) except for vomiting .", "no difference in gastrointestinal symptoms between the two treatments was found at t@ .", "regarding sf-@ evaluation , at t@ no statistical differences were found for each sf-@ parameter between the two regimens .", "at t@ both treatments significantly improved most of the evaluated sf-@ parameters in respect to baseline values .", "no difference in sf-@ parameters between the two treatments was found at t@ .", "both the medical device and domperidone significantly improved gastrointestinal symptoms and quality of life in subjects with functional dyspepsia , not showing significant difference in efficacy ." ]

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

[ "we conducted a prospective , double-blind study with a crossover design of intravesical bacillus calmette-guerin ( bcg ) and dimethyl sulfoxide to determine whether patients with classic and nonulcer interstitial cystitis , respectively , might benefit from either regimen .", "a total of @ patients , including @ with classic and @ with nonulcer interstitial cystitis , randomly underwent treatments with intravesical bcg or dimethyl sulfoxide and , if not improved , were treated with the other substance after a washout period .", "all @ patients were evaluated with symptom questionnaires , including a visual analog pain scale and voiding diaries .", "regardless of regimen , there was no improvement in maximal functional capacity .", "there was a reduction in urinary frequency following dimethyl sulfoxide treatment but only in the classic subtype ( p < @ ) , whereas no reduction was seen following bcg in either subtype .", "a substantial pain decrease was noted in classic ( p < @ ) as well as nonulcer ( p < @ ) interstitial cystitis following dimethyl sulfoxide .", "intravesical bcg has been presented as a promising new option for treatment of interstitial cystitis .", "we failed to demonstrate benefit from this treatment .", "dimethyl sulfoxide had no positive effect on maximal functional capacity but resulted in a significant reduction in pain and urinary frequency , although only in patients with classic interstitial cystitis ." ]

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

[ "to determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with @ mg/kg oral dexamethasone .", "randomized , double-blind , placebo-controlled trial .", "emergency department of a tertiary-care pediatric hospital with @,@ visits per year .", "children @ months to @ years of age with a syndrome consisting of hoarseness , inspiratory stridor , and barking cough and a croup score of @ or greater after at least @ minutes of mist therapy .", "patients were excluded from the study if they had diagnoses of epiglottitis , chronic upper or lower airway disease ( not including asthma ) , or severe croup or had received corticosteroids within the preceding @ weeks .", "all patients received @ mg/kg oral dexamethasone and were randomly assigned to receive @ ml ( @ mg ) of budesonide solution ( n = @ ) or @ ml of @ % saline solution ( n = @ ) by updraft nebulizer with a continuous flow of oxygen at @ to @ l/min .", "the primary outcome measure was the proportion of patients in each group who had clinically important changes ( two points ) in the croup score during the @ hours after treatment .", "eighty-four percent ( n = @ ) of the patients who received budesonide had clinically important responses , compared with @ % ( n = @ ) in the placebo group .", "the number of patients who would need to be treated with nebulized budesonide for one patient to have a clinically important response is four patients .", "despite receiving simultaneous oral dexamethasone , pediatric outpatients with mild to moderate croup have added , clinically important improvement in respiratory symptoms after treatment with budesonide ." ]

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

[ "the effect of fluvoxamine versus placebo on serum cholesterol levels in obese women undergoing behavior therapy for weight reduction was evaluated .", "forty obese female outpatients undergoing @ weeks of a behaviorally oriented treatment program for weight reduction were randomly assigned to double-blind treatment with fluvoxamine @ mg/day ( n = @ ) or placebo ( n = @ ) .", "total serum cholesterol levels were measured before and after the @-week study period .", "patients of the two treatment groups did not differ in age , weight , body mass index , cholesterol levels before treatment , and the extent of weight reduction during treatment .", "cholesterol levels were significantly lower after fluvoxamine treatment than before , whereas cholesterol levels remained unaltered after placebo administration .", "patients with initially high total cholesterol levels ( > or = @ mg/dl ) showed a significantly larger reduction than patients with desirable cholesterol levels .", "however , there was no interaction between treatment and initial cholesterol level .", "the results might suggest a cholesterol-lowering effect of fluvoxamine ." ]

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

[ "a new patented prolonged release formulation of the alpha@-adrenoceptor antagonist alfuzosin has been developed for once-daily ( od ) administration in benign prostatic hyperplasia ( bph ) .", "this study was designed to compare @ dose regimens : @ mg od alfuzosin and @ mg tid alfuzosin at steady state .", "in an open , randomized crossover study with a @-day washout between treatments , @ healthy male subjects ( @ - @ years ) received od or tid alfuzosin tablets orally over @ days .", "both formulations were administered according to the schedule recommended for therapeutic use : od was administered @ min after the evening meal , tid was administered in the evening , then in the morning and at noon ( @ min before meals ) .", "on the fifth day , plasma concentrations were quantitated by hplc with spectrofluorometric detection .", "the following pharmacokinetic parameters refer to the geometric mean values for both formulations .", "mean cmax value of @ mg od alfuzosin was @ ng/ml at a median t ( max ) of @ h ; cmax was higher and reached earlier from @ mg alfuzosin tid : @ ng/ml , @ ng/ml and @ at @ hour after each dosing , respectively .", "mean auc ( @-@ ) values after od and tid were @ and @ ng x h/ml , respectively .", "based on auc ( @-@ ) values corrected by the administered daily dose , the relative bioavailability of alfuzosin od was @ % with a @ % confidence interval of @ - @ % .", "non-corrected auc ( @-@ ) values were bioequivalent with a ratio estimate of @ % and a @ % confidence interval of @ - @ % .", "the higher daily dose compensated for the loss of bioavailability observed with the od formulation .", "mean t@/@z value was longer for the od ( @ h ) than the tid formulation ( @ h ) .", "variability between individuals was similar for the @ formulations .", "both dose regimens were well tolerated .", "alfuzosin @ mg once-daily provides a suitable pharmacokinetic profile for a once-daily administration , equivalent bioavailability between the @ dosage regimens and a good safety profile justify the use of alfuzosin @ mg in patients with bph ." ]

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

[ "to investigate the effects of lidocaine gel and parenteral antibiotics and povidine lavage in the treatment of pain occurring during prostate biopsy in terms of infective complications .", "eighty patients with indications for prostate biopsy were randomized into two groups .", "one group underwent lavage with povidine iodine solution and lidocaine gel , and the other received cephtriaxon and lavage .", "pain experienced by the patients was measured by visual analog scale ( vas ) .", "blood samples were taken @ and @ min after the procedure , and urine culture antibiograms were taken @ min after the procedure .", "the average pain score was @ in group @ and @ in group @ ; the difference between the groups was not statistically significant ( p > @ ) .", "likewise , no statistically significant difference between groups was found by the chi square test in either urine or blood cultures ( p > @ ) .", "lavage with betadine prior to transrectal prostate biopsy is adequate in the prevention of infective complications ; however , because lidocaine gel is not effective against pain , alternative methods for pain management need to be developed ." ]

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

[ "nasojejunal tube feeding is a standard of care in patients with predicted severe acute pancreatitis ( ap ) and several recent trials suggested that nasogastric tube feeding ( ngt ) is as safe and efficient as nasojejunal tube feeding in these patients .", "the aim was to investigate whether ngt presents any benefit to patients with mild to moderate ap .", "the study design was a randomized controlled trial .", "the patients in the intervention group received ngt within @ h of hospital admission .", "the patients in the control group were on nil per os ( npo ) .", "the severity of acute pancreatitis was determined according to the new international multidisciplinary classification .", "there were @ patients randomly allocated to the ngt group and @ to the npo group .", "the visual analogue pain score decreased to a significantly greater extent in the ngt group ( from median @ ( range @-@ ) at baseline to @ ( @-@ ) at @ h after randomization ) compared with the npo group ( from @ ( @-@ ) to @ ( @-@ ) ( p = @ ) .", "the number of patients not requiring opiates at @ h after randomization was significantly different ( p = @ ) between ngt ( @/@ ) and npo ( @/@ ) .", "oral food intolerance was observed in @/@ patient in the ngt group and @/@ patients in the npo group ( p = @ ) .", "the overall hospital stay in the ngt group was @ ( @-@ ) days as compared with @ ( @-@ ) days in the npo group ( p = @ ) .", "ngt commenced within @ h of hospital admission is well tolerated in patients with mild to moderate acute pancreatitis .", "further , when compared with npo , it significantly reduces the intensity and duration of abdominal pain , need for opiates , and risk of oral food intolerance , but not overall hospital stay ." ]

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

[ "although surgery is the treatment of choice for rectal cancer , local recurrence is common even after apparently curative resection .", "we aimed to assess the role of postoperative radiotherapy in reducing rates of local recurrence , and improving disease-free and overall survival in patients with mobile dukes ' stage b and c rectal cancers .", "we carried out a prospective , randomised trial of surgery alone ( n = @ ) versus surgery followed @-@ weeks later by radiotherapy ( n = @ ) , of @ gy in @ fractions of @ gy over @ weeks .", "the @ patients , from @ hospitals in the uk and the republic of ireland , were randomised between @ and @ , and followed up for a minimum of @ years or to death .", "@ patients died , @ of @ allocated surgery alone and @ of @ allocated postoperative radiotherapy .", "the hazard ratio for overall survival was @ ( @ % ci @-@ @ , p = @ ) .", "at @ years ' follow-up @ patients who received surgery alone and @ who received postoperative radiotherapy had had local recurrence ( hazard ratio @ [ @-@ @ ] , p = @ ) .", "the corresponding numbers with distant recurrence were @ and @ ( hazard ratio @ [ @-@ @ ] , p = @ ) .", "the hazard ratio for disease-free survival was @ ( @-@ @ ; p = @ ) .", "radiotherapy was generally well tolerated ; assessment of late events showed serious late bowel complications to be rare and not significantly increased after radiotherapy , even when this followed anterior resection .", "our results have provided further evidence of the ability of postoperative radiotherapy to delay and prevent local recurrence of rectal cancer .", "although the local recurrence rate in the control group is in keeping with other multi-centre trials of the mid to late @s , it is undoubtedly higher than would be regarded as acceptable now .", "the combination of larger trials required to provide definitive answers on the impact that postoperative radiotherapy will have on survival ." ]

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

[ "universal fortification of staple foods with iron has been widely promoted as a cost-effective strategy to reduce iron deficiency in developing-country populations .", "nonetheless , relatively few efficacy trials have been reported to date to demonstrate impact on iron status .", "the ultra rice technology provides a means of delivering fortificant iron via rice .", "the objective of this study was to test the efficacy of rice fortified with microencapsulated , micronized iron pyrophosphate to improve the iron status of women in mexico in a randomized , controlled intervention trial .", "nonpregnant , nonlactating women @ to @ years of age were recruited from six factories .", "the women received a daily portion of cooked rice @ days per week for a period of @ months , before and after which iron status indicators were determined in venous blood samples .", "the average intake of iron from the fortificant was @ mg/day .", "mean plasma ferritin concentration and estimated body iron stores were significantly higher , and transferrin receptors were lower , in the iron-fortified rice group following the intervention .", "mean hemoglobin concentration also increased in the treatment group , but the increase was significant only when the analysis was restricted to those with baseline hemoglobin < @ g/dl .", "the absolute reduction in anemia and iron deficiency was @ and @ percentage points , respectively .", "total iron intake from fortificant was a significant covariate of change in body iron stores .", "the overall prevalence of anemia was reduced by @ % .", "fortification of rice with iron using this technology is an efficacious strategy for preventing iron deficiency ." ]

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

[ "the aim of this study was to evaluate the effectiveness of a refined theory-based interactive postpartum sexual health education program to enhance postpartum women 's effective contraceptive behavior .", "participants ( n = @ ) were randomized to three groups .", "experimental group a received our intervention program via strategies that matched participants ' learning preparedness , as determined by the transtheoretical model .", "experimental group b received only a pamphlet .", "the control group received routine education .", "only group a received health education .", "data were collected at baseline , @ days , @ months and @ months postpartum .", "women who received theory-based postpartum sexual health education program had significantly greater contraceptive self-efficacy and were more likely to choose more effective contraceptive methods at @ months postpartum than women in the routine teaching and interactive pamphlet-only groups .", "our theory-based interactive postpartum sexual health education program enhanced postpartum women 's contraceptive self-efficacy and effective contraceptive behavior ." ]

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

[ "deterioration in social functioning and depression are often intertwined , particularly for women with histories of childhood sexual abuse ( csa ) .", "among women with csa histories , some relationship domains may be more modifiable than others during time-limited depression treatment .", "women with csa histories often report long-standing interpersonal difficulties in close relationships .", "thus , we expected that patients ' relationships with immediate family and intimate partners would be less likely to improve during treatment than relationships with co-workers , friends , or extended family , unless patients received an interpersonally-focused intervention that targeted close relationships .", "to examine domain-specific social functioning improvements and determine whether some domains were more likely than others to respond to an interpersonally-focused intervention , we analyzed data from a randomized controlled trial investigating interpersonal psychotherapy ( ipt ) vs. usual care ( uc ) in @ depressed women with csa histories .", "participants completed the social adjustment scale-sr at pretreatment , @ - , @ - , and @-weeks .", "consistent with our hypotheses , patients reported significant improvements in work roles , leisure activities with friends , and relationships with extended family members over the course of treatment .", "relationships with immediate family members and intimate partners did not improve in the overall sample .", "however , relationships with immediate family improved significantly more among ipt than uc patients .", "the sample size is small and generalizability may be limited .", "social functioning improvements during depression treatment may be domain-specific among depressed women with csa histories .", "ipt is more effective than uc at improving relationships with close family members in this population ." ]

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

[ "currently recognized risk factors for coronary artery disease have been identified primarily from investigations of white populations .", "in this investigation , we estimated mortality rates for coronary disease and for any cause and identified risk factors for death from coronary disease among whites and blacks .", "data collected over a @-year period in the charleston heart study were used to estimate mortality rates and quantify associations with risk factors assessed at the base-line examination in @ and @ of @ white men , @ black men , @ white women , and @ black women .", "there were no significant racial differences in the rate ratios for death from coronary disease ; however , women had significantly lower death rates than men .", "over the @-year period , the mortality rates for coronary disease per @ person-years were @ for white men ( @ percent confidence interval , @ to @ ) , @ for black men ( @ to @ ) , @ for white women ( @ to @ ) , and @ for black women ( @ to @ ) .", "significant , or nearly significant , predictors of mortality due to coronary disease were systolic blood pressure in all four groups ; serum cholesterol level among white men , white women , and black women ; and smoking among white men , white women , and black men .", "although the difference was not statistically significant , the risk of death from coronary disease was consistently increased among diabetics in all four groups .", "a higher level of education was predictive of lower rates of death due to coronary disease among white men and black women .", "for all causes of death taken together , the rates for blacks were higher than the rates for whites .", "the presence of hypertension , a history of smoking , and a history of diabetes were significant or nearly significant predictors of mortality from any cause in all four groups .", "although the rates of death from coronary disease were somewhat lower among black men than white men and higher among black women than white women , the black : white mortality rate ratios were not statistically significant , and the major risk factors for mortality from coronary disease were similar in blacks and whites in the @-year follow-up of the charleston heart study ." ]

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

[ "to evaluate the outcome of ovarian needle drilling using transvaginal ultrasound guidance as an alternative to the traditional laparoscopic electrosurgical drilling for patients with polycystic ovary syndrome ( pcos ) .", "a randomized controlled study .", "university teaching hospital and private practice setting .", "the study comprised @ patients with clomiphene-resistant pcos .", "patients were randomly allocated to either treatment with ultrasound-guided transvaginal needle ovarian drilling ( utnd ; n = @ ) or laparoscopic electrosurgery ovarian drilling ( n = @ ) .", "hormonal changes ( fsh , lh , t ) , ovulation and pregnancy .", "there were no significant differences between the two groups with regard to body mass index , hormonal profiles , clinical manifestations , and ultrasound findings of pcos .", "the duration of utnd was @ + / - @ minutes ( @-@ @ minutes ) , while it was @ + / - @ minutes ( @-@ @ minutes ) in laparoscopic drilling , with a statistically significant difference between the two groups .", "there were no significant differences between the two groups with regard to resumption of normal menstruation , hirsutism , acne , ovulation , and pregnancy .", "utnd resulted in significant improvement in the ovulation , pregnancy , hirsutism , and acne .", "there were significant decreases in the serum lh and t levels but not in the fsh or lh/fsh levels after utnd as well .", "utnd can be adopted as an outpatient office procedure .", "the ease of scheduling , reduced costs , and rapid recovery suggest it as a first-line treatment for pcos cases resistant to clomiphene citrate ." ]

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

[ "to determine the association between bispectral index ( bis ) and seizure duration obtained by electroconvulsive therapy ( ect ) administered sooner or later after anesthetic induction .", "prospective , randomized , crossover study .", "university-affiliated medical center .", "nine asa physical status i , ii , and iii patients undergoing a total of @ ects .", "ect was administered soon ( < @ sec ) or later ( between @ sec and @ sec ) after anesthetic induction .", "in each individual patient , drug regimens and ect machine settings were identical .", "bis immediately before the start of the ect and the duration of the eeg seizure were recorded , as well as the time period between loss of consciousness and ect administration .", "there was no relationship between bis level and seizure duration .", "moreover , seizure duration was not dependent on the time of ect administration in the time window between one and @ minutes after loss of consciousness .", "the hypnotic drug effect measured by the bis is not correlated to the seizure duration obtained by ect ." ]

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

[ "to compare efficacy and complications of spinal anesthesia versus general anesthesia in percutaneous nephrolithotomy ( pcnl ) .", "in a prospective randomized study , @ patients were randomly assigned into two groups for pcnl ; group @ ( n = @ ) underwent general anesthesia and group @ ( n = @ ) received spinal anesthesia .", "in group @ , pcnl was performed using standard technique under general anesthesia .", "in group @ , spinal anesthesia was done by injecting bupivacaine and fentanyl in spinal space l@ in sitting position .", "thereafter , a urethral catheter was placed in lithotomy position , head of the bed was tilted down for @ to @ minutes , and the level of anesthesia was checked .", "then , pcnl was done by standard technique .", "complications were recorded and analyzed by spss software using chi-square and student 's t tests .", "mean stone size in groups @ and @ was @ @ mm and @ @ mm , respectively .", "intra-operative hypotension and postoperative headache and low back pain were more in spinal group than the general group with a significant difference ( p < @ ) .", "no neurologic complication was observed in both groups .", "need to narcotic medications on the day of operation in groups @ and @ was @ @ mg and @ @ mg of morphine sulphate , respectively ( p = @ ) .", "the cost of anesthetic drugs was @ @ us $ and @ @ us $ in groups @ and @ , respectively ( p = @ ) .", "spinal anesthesia with combined bupivacaine and fentanyl is a safe , effective , and cost-effective method for performing pcnl in adult patients ." ]

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

[ "a mixture of neutral prebiotic oligosaccharides has been shown to reduce the incidence of atopic dermatitis ( ad ) and allergy associated symptoms during the first @ years of life .", "to evaluate if this protective effect against allergy lasted beyond the intervention period until @ y of age .", "in a prospective , double blind , placebo-controlled fashion , healthy term infants at risk of atopy were fed either a prebiotic-supplemented ( @ g/@ ml scgos/lcfos ) or placebo-supplemented ( @ g/@ ml maltodextrin ) hypoallergenic formula during the first @ mo of life .", "following this intervention period , follow-up continued until @ y of life .", "the present study evaluated ( i ) the cumulative incidence of allergic manifestations during @ y , and ( ii ) the prevalence of allergic and persistent allergic manifestations at @ y. monitored allergic manifestations were ad , recurrent wheezing , allergic rhinoconjunctivitis and urticaria .", "ninety-two children ( @ in placebo group , @ in intervention group ) completed the @-y follow-up .", "the @-y cumulative incidences of any allergic manifestation and atopic dermatitis were significantly lower in the scgos/lcfos group ( @ , @ % , respectively ) compared to placebo group ( @ , @ % , respectively ) ( p < @ and < @ ) .", "children in the scgos/lcfos group tended to have a lower incidence of allergic rhinoconjunctivitis , and allergic urticaria ( @ vs @ % for both manifestations , p = @ ) .", "there was no difference in the cumulative incidence of recurrent wheezing .", "with regard to the prevalences at @ y , intervention group had significantly lower prevalence of any persistent allergic manifestation and rhinoconjunctivitis ( @ , @ % , respectively ) compared to placebo ( @ , @ % , respectively ) ( p < @ and = @ ) .", "prevalence of persistent ad tended to be lower in the intervention group ( @ vs @ % , p = @ ) .", "although intervention group had @ % reduction in the prevalence of persistent wheezing ( @ vs @ % ) , no significance was shown .", "oligosaccharide prebiotics ( scgos/lcfos ) , when started early in life have a protective effect against allergic manifestations in high risk infants .", "the protection lasts beyond infancy until @ y of life , for ad and allergic rhinoconjunctivitis .", "long-term follow-up studies in larger populations are warranted to evaluate the potential preventive effect of this mixture on asthma ." ]

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

[ "research demonstrates a link between migraine and obesity .", "obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women .", "these findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical and non-surgical weight loss .", "however , no previous study has examined the effect of weight loss on migraine within a treatment-controlled framework .", "the wham trial is an rct to test the efficacy of behavioral weight loss as a treatment for migraine .", "overweight/obese women ( n = @ ; bmi = @-@ @ kg/m ( @ ) ) who meet international diagnostic criteria for migraine and record @ migraines and @-@ migraine days using a smartphone-based headache diary during a @-week baseline period , will be randomly assigned to @ months of either group-based behavioral weight loss ( intervention ) or migraine education ( control ) .", "intervention participants will be taught strategies to increase physical activity and consume fewer calories in order to lose weight .", "control participants will receive general education on migraine symptoms/triggers and various treatment approaches .", "both groups will use smartphones to record their headaches for @ weeks at baseline , after the @-week treatment period , and at the end of a @-week follow-up period .", "changes in weight and other potential physiological ( inflammation ) , psychological ( depression ) , and behavioral ( diet and physical activity ) mediators of the intervention effect will also be assessed .", "the wham trial will evaluate the efficacy of a standardized behavioral weight loss intervention for reducing migraine frequency , and the extent to which weight loss and other potential mediators account for intervention effects ." ]

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

[ "cervical cancer is the leading cause of cancer death among women in developing countries .", "this study was designed to evaluate whether visual inspection with acetic acid and magnification ( viam ) improved confirmation of cervical lesions as compared to confirmation with visual inspection with acetic acid ( via ) without magnification when used by physicians .", "from april-december @ , women in san martin , peru , who were referred as via-positive by an `` obstetriz '' ( a professional midwife with @ years of university training ) were randomized into two groups for confirmatory screening by a physician using either via or viam with an aviscope , a hand-held @x magnification scope with a green light source .", "the reference standard for the presence or absence of cervical neoplasia was colposcopy and directed biopsy , as required .", "a total of @ women participated in the study ; @ had a confirmatory examination with viam and @ with via .", "sensitivity for low - or high-grade lesions was @ % with via and @ % with viam , and specificity was @ % with via and @ % with viam ; however , these differences were not statistically significant .", "for settings where physician confirmation of cervical abnormalities identified through visual inspection is required and available , this study demonstrates that viam had no significant advantage over via ." ]

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

[ "endovascular repair offers a less surgically invasive procedure for abdominal aortic aneurysms but nevertheless , still requires analgesic sedative cover to ensure an acceptable level of patient comfort and cardiorespiratory stability .", "the peculiarity of this kind of operation is that painful stimuli are concentrated in specific moments separated by intervals devoid of pain , so the insurgence of pain can be predicted and prevented with a bolus of analgesic , making a continuous infusion not essential , but potentially useful in achieving a better analgesic stability .", "the primary objective of the study was pain control measured by visual analogue scale ; secondary endpoints were cardiorespiratory stability and an acceptable level of sedation .", "the sedative analgesic protocols of two groups of randomly allocated patients , undergoing abdominal aortic aneurysm endovascular repair , were compared .", "the experimental group received remifentanil infusion ( @-@ @ microg kg min ) and the control group received intravenous doses of fentanyl and midazolam ( @-@ microg kg and @-@ @ mg kg , respectively ) .", "fifty patients were investigated out of @ enrolled .", "there were no relevant differences concerning cardiorespiratory stability and level of sedation , but pain levels were significantly lower in the experimental group : mean visual analogue scale @ + / -@ vs. @ + / -@ ( p < @ ) and area under the curve @ + / -@ vs. @ + / -@ ( p < @ ) .", "both techniques were shown to be safe and most importantly effective in offering cardiovascular stability and analgesia for american society of anaesthesiologists iii-iv patients undergoing endovascular abdominal aortic aneurysm repair .", "however , remifentanil continuous infusion proved to offer significantly more stable pain control compared with the currently used combination fentanyl-midazolam ." ]

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

[ "calcipotriene has limited efficacy in treating psoriasis .", "by inhibiting proinflammatory cytokines such as interleukin-@ , interleukin-@ , and tumor necrosis factor-alfa , nicotinamide may enhance the efficacy of calcipotriene therapy when used in combination .", "we sought to determine if the combination of nicotinamide with calcipotriene is more effective than either component alone .", "in this randomized , double-blinded , multicenter @-arm bilateral comparison-controlled trial , patients were randomized to two of @ treatments -- placebo , calcipotriene @ % alone , nicotinamide @ % alone , calcipotriene plus nicotinamide @ % , calcipotriene plus nicotinamide @ % , calcipotriene plus nicotinamide @ % , or calcipotriene plus nicotinamide @ % -- each administered to lesions on one side of the body or to one of two lesions at least @ cm apart , for @ weeks .", "efficacy was measured using a clear to almost clear outcome .", "in all , @ % of patients in the calcipotriene and nicotinamide @ % combination group achieved a clear to almost clear outcome at week @ , compared with only @ % of patients treated with placebo ( p = @ ) , @ % of patients treated with nicotinamide @ % alone ( p = @ ) , and @ % of patients treated with calcipotriene alone ( p = @ ) .", "a dose-response trend existed for increasing concentrations of nicotinamide , but it was not significant .", "the relatively small patient numbers , relatively high placebo effect , and maximum in-life portion of only @ weeks of dosing are weaknesses of the study .", "this study provides evidence that using the combination nicotinamide and calcipotriene may provide additional benefit in the topical treatment for patients with psoriasis and may be an adequate steroid-sparing substitute treatment ." ]

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

[ "to compare the efficacy of pulsatile gnrh therapy versus combined gonadotropins for ovulation induction in women with both hypothalamic amenorrhoea and polycystic ovarian syndrome ( ha/pcos ) according to their current hypothalamic status .", "this single-centre , prospective , randomized study was conducted in the nantes university hospital , france .", "thirty consecutive patients were treated for ovulation induction with either pulsatile gnrh therapy or combined gonadotropins ( rfsh + rlh ) .", "frequency of adequate ovarian response ( mono - or bi-follicular ) and clinical pregnancy rate were then compared between both groups .", "ovarian response was similar in both groups with comparable frequency of adequate ovarian response ( @ % vs @ % ) , but the clinical pregnancy rate was significantly higher in the pulsatile gnrh therapy group than in the combined gonadotropin group ( @ % vs @ % ) .", "ha/pcos is a specific subgroup of infertile women .", "pulsatile gnrh therapy is an effective and safe method of ovulation induction that can be used successfully in these patients ." ]

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

[ "laparoscopic gastric plication ( lgp ) is emerging as a safe and effective bariatric procedure .", "however , there are no reports on the comparison between the efficacy and complications of lgp and laparoscopic mini-gastric bypass ( lmgb ) , which is still an investigational bariatric procedure .", "the objective of this study was to compare safety and efficacy of lgp and lmgb in the treatment of morbid obesity in a one-year follow-up study .", "forty patients met the national institutes of health criteria and were randomly assigned to receive either lgp ( n = @ ) or lmgb ( n = @ ) by a block randomization method .", "early and late complications , body mass index ( bmi ) , excess weight loss , and obesity-related co-morbidities were determined at the @-year follow-up .", "operative time and mean length of hospitalization were shorter in the lgp group ( @ minutes versus @ minutes , p < @ , and @ days versus @ days ; p < @ , respectively ) .", "the mean percentage of excess weight loss ( % ewl ) at @ months follow-up was @ % in the lmgb group and @ % in the lgp group ( p = @ ) .", "improvement was observed in all co-morbidities in both groups , with the exception of hyperlipidemia , which remained unresolved in @ patients .", "lower incidence of iron deficiency occurred in the lgp group ( p = @ ) .", "rehospitalization and reoperation were not required in any cases .", "considering the cost of instruments used in the lmgb procedure and operative time , lgp saved approximately $ @,@ per case compared with lmgb .", "both lgp and lmgb are effective weight loss procedures .", "lgp proved to be a simpler and less costly procedure compared with lmgb with a lower risk of iron deficiency during a @-year follow-up study ." ]

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

[ "to evaluate the efficacy and safety of sealed-capsule irrigation ( sci ) using distilled water ( dw ) to prevent posterior capsule opacification ( pco ) .", "phacoemulsification was performed in @ patients .", "patients were randomly selected into groups .", "in the control the capsular bag was mechanically cleaned ( mc ) , in the dw group dw for @ ' in sci was additionally applied .", "sn@wf iol was implanted in all eyes .", "examinations were performed before and @ , @ , @ days , one and two years after surgery .", "uncorrected and corrected distance visual acuity ( udva , cdva ) , intraocular pressure ( iop ) , surgically induced astigmatism ( k@-sia ) , spherical equivalent ( seq ) , endothelial cell and the complications were examined .", "total pco score in the area of @ and @mm zone and capsulorhexis ( caps ) were determined using epco @ .", "one patient was withdrawn from the dw group as he did not report for the examinations .", "as far as safety parameters are concerned , no differences were observed between groups in two-year follow-up ( p > @ ) .", "however , in the dw group the endothelial cell loss was higher ( p < @ ) .", "total pco score differences were observed in both groups between the areas ( p < @ ) .", "in the caps area , both total pco score and pco area were decreased in the dw group ( p < @ ) .", "pco was also lower within @mm zone in the dw group ( p < @ ) .", "sci is a safe procedure and the endothelial cells loss can be associated with the perfect capsule device ( milvella ) in the anterior chamber insertion .", "dw irrigated for @ ' reduces pco in long-term follow-up ." ]

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

[ "all-trans-retinoic acid induces complete remission in acute promyelocytic leukemia .", "however , it is not clear whether induction therapy with all-trans-retinoic acid is superior to chemotherapy alone or whether maintenance treatment with all-trans-retinoic acid improves outcome .", "three hundred forty-six patients with previously untreated acute promyelocytic leukemia were randomly assigned to receive all-trans-retinoic acid or daunorubicin plus cytarabine as induction treatment .", "patients who had a complete remission received consolidation therapy consisting of one cycle of treatment identical to the induction chemotherapy , then high-dose cytarabine plus daunorubicin .", "patients still in complete remission after two cycles of consolidation therapy were then randomly assigned to maintenance treatment with all-trans-retinoic acid or to observation .", "of the @ patients treated with chemotherapy , @ ( @ percent ) had a complete remission , as did @ of the @ ( @ percent ) given all-trans-retinoic acid ( p = @ ) .", "when both induction and maintenance treatments were taken into account , the estimated rates of disease-free survival at one , two , and three years were @ , @ , and @ percent , respectively , for patients assigned to chemotherapy then all-trans-retinoic acid ; @ , @ , and @ percent for all-trans-retinoic acid then all-trans-retinoic acid ; @ , @ , and @ percent for all-trans-retinoic acid then observation ; and @ , @ , and @ percent for chemotherapy then observation .", "by intention-to-treat analysis , the rates of overall survival at one , two , and three years after entry into the study were @ , @ , and @ percent , respectively , among patients assigned to chemotherapy , and @ , @ , and @ percent among those assigned to all-trans-retinoic acid ( p = @ ) .", "all-trans-retinoic acid as induction or maintenance treatment improves disease-free and overall survival as compared with chemotherapy alone and should be included in the treatment of acute promyelocytic leukemia ." ]

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

[ "in many patients , ventricular arrhythmias will develop early after acute myocardial infarction .", "we studied the incidence , timing , and outcomes of such arrhythmias in the international global utilization of streptokinase and tpa ( alteplase ) for occluded coronary arteries ( gusto ) - iii trial .", "we identified independent predictors of inhospital ventricular fibrillation ( vf ) and ventricular tachycardia ( vt ) and compared @-day and @-year mortality rates of patients who did ( n = @ ) and did not ( n = @,@ ) have these arrhythmias during the index hospitalization .", "significant independent predictors of inhospital vf were higher killip class , lower baseline systolic pressure , intravenous preenrollment lidocaine use , shorter time to thrombolysis , and beta-blocker use < @ weeks before enrollment ; independent predictors of inhospital vt were lower baseline systolic pressure , intravenous lidocaine use before enrollment , higher killip class , faster baseline heart rate , and advanced age .", "the @-day mortality rate was @ % in patients with vf , @ % in those with vt , @ % in those with both , and @ % in those with neither ( p = @ ) .", "the corresponding @-year mortality rates were @ % , @ % , @ % , and @ % ( p = @ ) .", "the @-day and @-year mortality rates were higher for patients with late ( > @ hours after enrollment ) versus early arrhythmias ( < or = @ hours after enrollment ) .", "despite thrombolysis , inhospital ventricular arrhythmias are associated with higher @-day and @-year mortality rates after acute myocardial infarction , particularly when occurring later during the initial hospitalization .", "better therapies are needed to improve outcomes of these arrhythmias ." ]

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

[ "the effects of ketanserin on primary or secondary raynaud 's phenomenon due to connective tissue disease were studied in a large , international group of patients .", "the study population consisted of @ patients from @ countries .", "after a run-in period of one month of placebo therapy , patients were randomly assigned in a double-blind manner to receive ketanserin @ mg three times daily ( n = @ ) or placebo ( n = @ ) for three months .", "total finger blood flow was measured in @ patients in a warm and cool room before and during treatment .", "vasospastic episodes were assessed by diaries and global evaluations .", "a significant reduction of @ % in frequency of episodes occurred with ketanserin , compared to @ % with placebo ( p = @ ) .", "there was a @ % reduction in duration of episodes with ketanserin therapy , compared to a @ % increase with placebo therapy , but this finding was not statistically significant ( p = @ ) .", "no difference was observed in severity of attacks .", "global evaluations by investigators ( p = @ ) and patients ( p less than @ ) showed an overall benefit with ketanserin compared to that seen with placebo .", "patients with primary or secondary raynaud 's phenomenon responded similarly to treatment .", "no changes in total finger blood flow were found .", "ketanserin significantly improves the subjective symptoms of patients with primary or secondary raynaud 's phenomenon and is an appropriate agent to use in this disease when conservative measures fail ." ]

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

[ "self-help agencies ( shas ) are consumer-operated service organizations managed as participatory democracies .", "members are involved in all aspects of organizational management , because a premise of shas is that organizationally empowered individuals become more empowered in their own lives , which promotes recovery .", "the study sought to determine the effectiveness of combined sha and community mental health agency ( cmha ) services in assisting recovery for persons with serious mental illness .", "a weighted sample of new clients seeking cmha services was randomly assigned to regular cmha services or to combined sha-cmha services at five proximally located pairs of sha drop-in centers and county cmhas .", "member-clients ( n = @ ) were assessed at baseline and at one , three , and eight months on five recovery-focused outcome measures : personal empowerment , self-efficacy , social integration , hope , and psychological functioning .", "scales had high levels of reliability and independently established validity .", "outcomes were evaluated with a repeated-measures multivariate analysis of covariance .", "overall results indicated that combined sha-cmha services were significantly better able to promote recovery of client-members than cmha services alone .", "the sample with combined services showed greater improvements in personal empowerment ( f = @ , df = @ and @ , p < @ ) , self-efficacy ( f = @ , df = @ and @ , p < @ ) , and independent social integration ( f = @ , df = @ and @ , p < @ ) .", "hopelessness ( f = @ , df = @ and @ , p < @ ) and symptoms ( f = @ , df = @ and @ , p < @ ) dissipated more quickly and to a greater extent in the combined condition than in the cmha-only condition .", "member-empowering shas run as participatory democracies in combination with cmha services produced more positive recovery-focused results than cmha services alone ." ]

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

[ "although several randomized controlled trials examined the relative benefits of coronary artery bypass graft ( cabg ) surgery and percutaneous coronary intervention ( pci ) , the most appropriate treatment remains a matter of debate , at least in some subsets of patients .", "therefore , we evaluated the @-year outcome after multivessel stent implantation ( stent group ) or coronary artery bypass surgery ( cabg group ) in a single-center propensity-matched cohort study .", "the stent study population consisted of all @ consecutive patients who underwent an elective coronary intervention between @ and @ in whom at least @ stents were implanted in multiple vessels .", "they were matched by using the propensity score method with @ cabg patients of @,@ cabg patients with multivessel disease who underwent elective cabg in the same period of time .", "the two populations were very different before matching .", "after matching , the cabg population resembled a stent population .", "the cumulative survival rates after stent were @ % , @ % , and @ % at , respectively , @ , @ , and @ years ; and after cabg @ % , @ % , and @ % ( p = @ ) .", "this was caused mainly by patients with left main disease ( p = @ ) .", "event-free survival was only @ % , @ % , and @ % after stent and @ % , @ % , and @ % after cabg at , respectively , @ , @ , and @ years ( p < @ ) .", "after adjusting , stent was an independent predictor of higher mortality .", "in this matched cohort study with an @-year follow-up , survival was better and less repeat revascularizations were needed among patients undergoing elective cabg for the treatment of multivessel disease as compared with the stent group ." ]

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

[ "in many countries low-molecular-weight heparins ( lmwhs ) are increasingly used for hemodialysis ( hd ) .", "low-range activated clotting time ( act-lr ) values and anti-xa activity had been used to monitor the degree of anticoagulation caused by lmwh .", "however , the facilities are not easily available at most hospitals .", "such data are limited in taiwan .", "a total of @ patients receiving maintenance hd were prospectively enrolled .", "the hd patients were randomized to receive either nadroparin or enoxaparin and checked the act-lr values and anti-xa activity .", "we aimed to analyze act-lr values and anti-xa activity along with the clotting of the dialyzer or bleeding events associated with two lmwhs after they were administered .", "we also aimed to determine the dose necessary to reach maximum safety and efficacy .", "we found no significant differences in lmwh dosage , act-lr values , and anti-xa activity between the two groups .", "there were no significant differences in bleeding/adverse events and extracorporeal circuit thrombosis between the two groups .", "most of the bleeding and adverse events were subcutaneous minor bleeding .", "no major bleeding or mortality was found .", "we found significant differences in mean dosage , cost , bleeding/adverse effect , and extracorporeal circuit thrombosis between excessive and reduced nadroparin dosage groups .", "lmwh is not still routinely used due to its high cost in taiwan .", "in our clinical experience , nadroparin and enoxaparin exhibited high levels of safety and efficacy in chronic hd patients .", "reduced lmwhs dosage could promote patient 's safety and decreased hd cost in hd patients with excessive dosage of lmwhs ." ]

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

[ "to compare effects of integrated treatment traditional chinese medicine and western medicine ( tcm-wm ) and simple western medicine on tcm clincal symptoms in the patient of aids with pulmonary inflammation .", "a multicenter randomized controlled trials of @ subjects evaluated the effects of clinical symptoms of aids with pulmonary inflammation of two regimens : the tcm-wm group ( n = @ ) and western medicine treatment group ( n = @ ) , while incidence of tcm symptoms in different time points in two groups were analyzed .", "twenty eight days after treatment , the cured and markedly effective rate of tcm symptoms in the tcm-wm group significantly exceeding that in the western medicine treatment group ( cured and markedly effective rate significant efficiency @ % vs @ % ) , while the incidence rate for the tcm symptoms of fever and headache in the tcm-wm group was significantly lower than that in western medicine group .", "the integrated treatment of traditional chinese medicine and western medicine helps to alleviate the tcm clinical symptoms of aids with pulmonary inflammation ." ]

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

[ "to evaluate the impact of two different modes of shoulder injection training on the level of confidence and number of injections performed by general practitioners ( gps )", "demographic details , and information on referrals for shoulder problems , shoulder joint injection activity , and confidence in the six months before training were obtained for @ gp principals at baseline .", "standardised training in the techniques of shoulder joint injection using rubber mannequins was given to all gps .", "twenty of these gps were randomly allocated to receive additional training on patients in hospital joint injection clinics .", "six months after both forms of training the shoulder injection and referral activities of all gps were reassessed .", "both training groups had comparable demographic characteristics and baseline clinical activity .", "gps who had additional training with patients reported a marked increase in their level of confidence in performing shoulder injections and the number performed .", "the number of shoulder referrals did not differ between the groups", "training on patients in addition to conventional training on mannequins increased gps ' shoulder injection activity and their level of confidence .", "hospital injection clinics may provide a suitable setting in which to train gps interested in developing their shoulder joint injection skills ." ]

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

[ "to evaluate the relationship between number of metabolic syndrome ( mets ) - like components and prostate cancer diagnosis in a group of men where nearly all biopsies were taken independent of prostate-specific antigen ( psa ) level , thus minimising any confounding from how the various mets-like components may influence psa levels .", "we analysed data from @ men in the reduction by dutasteride of prostate cancer events ( reduce ) study with at least one on-study biopsy .", "reduce compared dutasteride vs placebo on prostate cancer risk among men with an elevated psa level and negative pre-study biopsy and included two on-study biopsies regardless of psa level at @ and @ years .", "available data for mets-like components included data on diabetes , hypertension , hypercholesterolaemia , and body mass index .", "the association between number of these mets-like components and prostate cancer risk and low-grade ( gleason sum < @ ) or high-grade ( gleason sum > @ ) vs no prostate cancer was evaluated using logistic regression .", "in all , @ men ( @ % ) had one mets-like component , @ ( @ % ) had two , and @ ( @ % ) had three or four .", "men with more mets-like components had lower psa levels ( p = @ ) .", "one vs no mets-like components was protective for overall prostate cancer ( p = @ ) and low-grade prostate cancer ( p = @ ) .", "two ( p = @ ) or three to four ( p = @ ) mets-like components were not significantly related to prostate cancer .", "while one mets-like component was unrelated to high-grade prostate cancer ( p = @ ) , two ( p = @ ) or three to four mets-like components ( p = @ ) were associated with increased high-grade prostate cancer risk , although only the latter was significant .", "when biopsies are largely psa level independent , men with an initial elevated psa level and a previous negative biopsy , and multiple mets-like components were at an increased risk of high-grade prostate cancer , suggesting the link between mets-like components and high-grade prostate cancer is unrelated to a lowered psa level ." ]

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

[ "infrared photocoagulation ( irp ) is commonly used in the treatment of hemorrhoids , but rectal bleeding can persist after this procedure .", "adjuvant therapy may thus be considered for more definitive control of symptoms , particularly bleeding .", "the goal of this study was to compare the efficacy of a treatment combining irp and oral micronized purified flavonoid fraction ( mpff ) versus each treatment used alone on bleeding cessation in patients with grades i , ii , and iii acute internal hemorrhoids .", "this was a prospective , randomized , controlled , single-blind study .", "consecutive outpatients were randomly assigned to a treatment combining mpff and irp or to each treatment separately .", "for each patient , bleeding status was reported at day @ ( day of inclusion ) and compared with that at day @ after treatment by observers blinded to treatment assignment .", "follow-up visits were planned at days @ , @ , @ , and @ of therapy , including monitoring of treatment-related side effects and self-reporting by patients of any problem related to hemorrhoidal disease .", "a total of @ patients ( @ women , @ men ) were enrolled in the study .", "their mean age was @ years ( range , @-@ years ) .", "hemorrhoids were grade i in @ % ( @ patients ) , grade ii in @ % ( @ patients ) , and grade iii in @ % ( @ patients ) of the study population .", "patients were randomly assigned to each of the @ treatment groups ( @ patients in each ) , with no significant difference between groups in the age , sex , or distribution of grade of hemorrhoids .", "the percentage of patients with no bleeding after @ days of treatment was higher in the combined treatment group ( @ % ) compared with mpff alone ( @ % ; p = @ ) or with irp alone ( @ % ; p = @ ) .", "mpff alone was as effective as irp alone at stopping bleeding .", "patients with grades i and ii hemorrhoids responded significantly better ( @ % and @ % , respectively ) to either treatment than those with grade iii hemorrhoids ( @ % ; p < @ ) .", "of the @ patients who were followed up for @ days , @ had a gastrointestinal adverse event , and @ had a relapse of bleeding .", "five days of treatment combining mpff with irp significantly reduced bleeding status in these study patients with grades i and ii acute internal hemorrhoids compared with each treatment used alone ." ]

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

[ "the aim of this study was to assess the relative bioavailability of diazepam after administration of diazepam itself or as a water-soluble prodrug , avizafone , in humans .", "the study was conducted in an open , randomized , single-dose , three-way , cross-over design .", "each subject received intramuscular injections of avizafone ( @ mg ) , diazepam ( @ mg ) or avizafone ( @ mg ) combined with atropine ( @ mg ) and pralidoxime ( @ mg ) using a bi-compartmental auto-injector ( aibc ) .", "plasma concentrations of diazepam were quantified using a validated lc/ms-ms assay , and were analysed by both a non-compartmental approach and by compartmental modelling .", "the maximum concentration ( c ( max ) ) of diazepam after avizafone injection was higher than that obtained after injection of diazepam itself ( @ vs. @ ng.ml ( -@ ) ) , while area under the curve ( auc ) values were equal .", "diazepam concentrations reached their maximal value faster after injection of avizafone .", "injection of avizafone with atropine-pralidoxime ( aibc ) had no effect on diazepam c ( max ) and auc , but the time to c ( max ) was increased , relative to avizafone injected alone .", "according to the akaike criterion , the pharmacokinetics of diazepam after injection as a prodrug was best described as a two-compartment with zero-order absorption model .", "when atropine and pralidoxime were injected with avizafone , the best pharmacokinetic model was a two-compartment with a first-order absorption model .", "diazepam had a faster entry to the general circulation and achieved higher c ( max ) after injection of prodrug than after the parent drug .", "administration of avizafone in combination with atropine and pralidoxime by aibc had no significant effect on diazepam auc and c ( max ) ." ]

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

[ "depression is common in adolescent offspring of depressed parents and can be prevented , but adoption of prevention programs is dependent on the balance of their incremental costs and benefits .", "to examine the incremental cost-effectiveness of a group cognitive behavioral intervention to prevent depression in adolescent offspring of depressed parents .", "cost-effectiveness analysis of a recent randomized controlled trial .", "kaiser permanente northwest , a large health maintenance organization .", "teens @ to @ years old at risk for depression .", "usual care ( n = @ ) or usual care plus a @-session group cognitive therapy prevention program ( n = @ ) .", "clinical outcomes were converted to depression-free days and quality-adjusted life-years .", "total health maintenance organization costs , costs of services received in other sectors , and family costs were combined with clinical outcomes in a cost-effectiveness analysis comparing the intervention with usual care for @ year after the intervention .", "average cost of the intervention was $ @ , and total direct and indirect costs increased by $ @ in the intervention group .", "however , the result was not statistically significant , suggesting a possible cost offset .", "estimated incremental cost per depression-free day in the base-case analysis was $ @ ( @ % confidence interval , - $ @ to $ @ ) or $ @ per quality-adjusted life-year ( @ % confidence interval , - $ @ @ to $ @ @ ) .", "societal cost-effectiveness of a brief prevention program to reduce the risk of depression in offspring of depressed parents is comparable to that of accepted depression treatments , and the program is cost-effective compared with other health interventions commonly covered in insurance contracts ." ]

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

[ "to assess the effect of regular diabetic health education on cardiovascular risk factors in chinese type @ diabetic patients .", "this was a @-year prospective randomized study .", "one hundred and eighty type @ diabetic subjects were recruited from three regional diabetic centres in hong kong .", "ninety received additional structured reinforcement of diabetic health education by a trained nurse after the doctors ' consultations every @ months ( intervention group ) .", "the others received the same medical care except no nursing reinforcement ( control group ) .", "outcome measures included fasting plasma glucose , hba ( @c ) , body mass index , waist circumference , blood pressure and lipid profiles , which were assessed before the study and after @ year .", "two of the controls defaulted follow-up .", "the intervention group and controls had similar age and sex distribution .", "at the end of study , the intervention group had reducted their waist circumference , diastolic blood pressure , hba ( @c ) , total cholesterol and low-density lipoprotein cholesterol levels .", "the controls had reduced their total cholesterol and low-density lipoprotein cholesterol levels .", "other cardiovascular risk factors were not significantly changed in the controls .", "addition of drugs and/or dosage increment of anti-diabetic drugs , lipid-lowering agents and anti-hypertensive agents were similar between the two groups .", "regular structured reinforcement with diabetic health education is useful .", "it helps to control more successfully some of the cardiovascular risk factors in chinese type @ diabetic patients ." ]

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

[ "to assess the efficacy of interferon beta ( ifn beta ) in combination with methotrexate in treatment of patients with rheumatoid arthritis .", "@ patients with active rheumatoid arthritis , who had been on methotrexate for at least six months and at a stable dose for four weeks before study entry , were randomised in double blind fashion to receive placebo ( @ ml or @ ml ) , ifn beta @ microg ( @ ml ) , or ifn beta @ microg ( @ ml ) , given subcutaneously three times weekly for @ weeks .", "the primary efficacy measure was a change in radiological scores at week @ .", "the secondary endpoint was the proportion of patients who met the acr @ % improvement criteria at the end of the study .", "synovial biopsy specimens were obtained before and after treatment from a subset of patients .", "immunohistochemistry was used to detect the presence of inflammatory cells and the results were measured by digital image analysis .", "collagen crosslinks were measured in urine at different times throughout the study .", "analysis of radiological scores and clinical variable showed no changes in any of the groups , and there were no differences between the groups .", "on microscopic analysis of synovial tissue there was no significant change in the scores for infiltration by inflammatory cells after ifn beta treatment .", "urinary levels of collagen crosslinks were unchanged between the treatment groups .", "at the doses tested , treatment with ifn beta three times weekly in combination with methotrexate did not have a clinical or radiological effect in patients with rheumatoid arthritis ." ]

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

[ "to elucidate the prospects administration of allicor ( long-releasing garlic tablets ) in prevention of acute respiratory diseases ( ard ) in children vs benzimidazole ( dibazole ) .", "at the first stage , tolerance of allicor ( @ mg/day ) and its effects on ard morbidity were investigated in an opened @-month study in @ children aged @-@ years compared to @ controls .", "as the second stage , the effects of allicor ( @ mg/day ) on asrd morbidity were investigated in a double-blind placebo-controlled randomized @-month trial in @ children aged @-@ years in comparison with @ placebo-treated children and @ benzimidazole-treated children .", "at the first stage of the study allicor was not observed to induce gastrointestinal side effects in children at any dosage while ard morbidity was reduced @-@-fold as compared to the controls .", "at the second stage of the study allicor reduced ard morbidity @-fold compared to placebo and @-fold vs benzimidazole .", "there was no significant difference in ard morbidity between placebo - and benzimidazole-treated groups .", "health index in allicor-treated group was @-fold higher as compared either to placebo - or benzimidazole-treated children .", "thus , the results of this study have demonstrated that allicor is effective for non-specific prevention of acute respiratory infections in children and has no side effects .", "ard prevention with benzimidazole appeared ineffective in placebo-controlled study , so the development of new useful and safe preparations is of ultimate importance ." ]

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

[ "to determine the percentage of elective abdominal aortic aneurysms ( aaas ) / aortoiliac aneurysms that currently can be repaired with endovascular grafts ( evgs ) , the reasons for rejection of evgs , and the future role of evg in the treatment of aaa .", "from january @ to may @ , patients at three hospitals ( a university hospital , a university-affiliated teaching hospital , and a veterans administration hospital with university faculty and residents ) were evaluated for evgs as part of a national clinical trial with grafts manufactured by endovascular technologies ( evt , menlo park , calif ) .", "all patients at two hospitals and patients treated by the participating surgeons at the third hospital were screened for evg .", "patients with aaas that were ruptured , symptomatic , or involved renal or mesenteric arteries and patients who declined treatment were excluded from the study .", "evaluation included clinical examination , computed tomography scan , and selective arteriography .", "the decision to proceed with evg was made by the vascular surgeon , with input and concurrence of medical personnel from a company with extensive experience in endograft repair .", "the main outcome measures were the determination of the percentage of elective aaas currently being treated with an evg and the reasons for exclusion of patients from evg placement .", "a total of @ patients underwent elective treatment of an aaa , @ ( @ % ) with an evg ( @ bifurcated , eight tube ) and @ ( @ % ) with traditional resection .", "indications for not proceeding with an evg included insufficient proximal cuff in @ patients ( @ % ) , distal common iliac aneurysm or insufficient distal iliac neck in @ patients ( @ % ) , proximal neck too large for an evg in @ patients ( @ % ) , symptomatic iliac stenosis in @ patients ( @ % ) , iliac stenosis precluding introducer passage in @ patients ( @ % ) , patient preference in @ patients ( @ % ) , and calcification , kink , or extensive thrombus involving the proximal neck precluding safe graft attachment in seven patients ( @ % ) .", "of the @ patients treated with an evg , three were converted to open resection , because of iliac stenosis in two patients and premature stent deployment in one patient ( initial technical success rate , @ % ) .", "based on currently available technology , @ % of patients were not candidates for an evg because of proximal calcification , short aortic or distal cuff , coexisting distal iliac aneurysm , and stenotic iliac disease .", "even with the use of adjunctive procedures , most patients still require open repair .", "significant changes in design will be necessary to apply these devices to most patients with an aaa ." ]

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

[ "fortification of human milk ( hm ) is a common clinical practice to adapt breast milk to the nutritional needs of very low birth weight ( vlbw ) infants .", "the optimal method for hm fortification remains to be determined , and a variety of protocols are currently used in neonatal intensive care units .", "it is believed that standard fortification is insufficient to meet the needs of vlbw infants .", "therefore , we designed a randomized prospective study that investigated the effects of varying levels of blind fortification on short-term growth and metabolic responses of preterm infants .", "eligible infants were randomized into @ groups : standard fortification ( sf ) , moderate fortification ( mf ) , and aggressive fortification ( af ) .", "short-term growth , feeding intolerance , and urea , calcium , phosphorus , and alkaline phosphatase levels were assessed .", "there were @ , @ , and @ infants in the sf , mf , and af groups , respectively .", "the baseline characteristics of the groups were similar .", "daily weight gain and length at discharge did not differ among the groups ; however , head circumference was significantly higher in the mf and af groups compared with the sf group .", "urea , calcium , phosphorus , and alkaline phosphatase levels were similar between the groups .", "we demonstrated that blind fortification of hm , even with higher amounts than recommended by manufacturers , did not cause any measured adverse effects on the metabolic response of preterm infants .", "anthropometric measurements ( except head circumference ) were not different between the different dosages of fortification ." ]

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

[ "the interleukin-@ receptor ( il-@r ) blocker tocilizumab ( tcz ) reduces inflammatory disease activity in rheumatoid arthritis ( ra ) but elevates lipid concentrations in some patients .", "we aimed to characterise the impact of il-@r inhibition on established and novel risk factors in active ra .", "randomised , multicentre , two-part , phase iii trial ( @-week double-blind , @-week open-label ) , measure , evaluated lipid and lipoprotein levels , high-density lipoprotein ( hdl ) particle composition , markers of coagulation , thrombosis and vascular function by pulse wave velocity ( pwv ) in @ patients with ra who received tcz or placebo .", "median total-cholesterol , low-density lipoprotein-cholesterol ( ldl-c ) and triglyceride levels increased in tcz versus placebo recipients by week @ ( @ % vs @ % , @ % vs @ % , @ % vs -@ % , respectively ; all p < @ ) .", "there were no significant differences in mean small ldl , mean oxidised ldl or total hdl-c concentrations .", "however , hdl-associated serum amyloid a content decreased in tcz recipients .", "tcz also induced reductions ( > @ % ) in secretory phospholipase a@-iia , lipoprotein ( a ) , fibrinogen and d-dimers and elevation of paraoxonase ( all p < @ vs placebo ) .", "the apob/apoa@ ratio remained stable over time in both groups .", "pwv decreases were greater with placebo than tcz at @weeks ( adjusted mean difference @ m/s ( @ % ci @ to @ ; p = @ ) ) .", "these data provide the first detailed evidence for the modulation of lipoprotein particles and other surrogates of vascular risk with il-@r inhibition .", "when compared with placebo , tcz induced elevations in ldl-c but altered hdl particles towards an anti-inflammatory composition and favourably modified most , but not all , measured vascular risk surrogates .", "the net effect of such changes for cardiovascular risk requires determination ." ]

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

[ "the increase in serum c-reactive protein ( crp ) levels is an independent determinant of cardiovascular events in long-term hemodialysis ( hd ) patients .", "recently , statins have shown anti-inflammatory properties in addition to their lipid-lowering effect .", "we designed a @-month , prospective , randomized , controlled study to assess the safety and efficacy of atorvastatin in reducing serum crp levels in long-term hd patients .", "patients on hd therapy for at least @ months , with autologous vascular access , were included .", "patients presenting with illnesses and/or use of drugs that may affect crp levels were excluded .", "after randomization , group a included @ patients treated with atorvastatin ( @ mg/d orally ) , and group b included @ patients treated with placebo .", "body mass index , kt/v , normalized protein catabolic rate , mean blood pressure , and levels of hemoglobin , serum crp , albumin , creatinine , lipids , and enzymes were recorded at baseline and after @ months .", "qualitative/quantitative parameters were homogeneous between the groups at baseline .", "in group a , median serum crp levels decreased from @ mg/l ( range , @ to @ mg/l ) at baseline to @ mg/l ( range , @ to @ mg/l ) after @ months ( p = @ ) .", "in group b , values were @ mg/l ( range , @ to @ mg/l ) at baseline and @ mg/l ( range , @ to @ mg/l ) after @ months ( p = @ ) .", "serum crp levels were lower in group a than group b at month-@ ( @ mg/l ; range , @ to @ mg/l versus @ mg/l ; range , @ to @ mg/l , respectively ; p = @ ) and month-@ evaluations ( @ mg/l ; range , @ to @ mg/l versus @ mg/l ; range , @ to @ mg/l , respectively ; p = @ ) .", "after @ months , only in group a was there a significant decrease in serum cholesterol levels ( p = @ ) and a significant increase in serum albumin levels ( p = @ ) .", "enzyme levels were stable during the study in both groups .", "administration of atorvastatin is safe in patients on long-term hd therapy and , in addition to its beneficial effects on lipid levels , induces a significant decrease in serum crp levels , with a consequential increase in serum albumin levels ." ]

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

[ "the purpose of this study was to compare the immediate microtensile bond strength ( microtbs ) of two-step etch-and-rinse adhesive systems to the dentin of primary and permanent teeth .", "non-carious human teeth ( @ primary molars and @ premolars ) were assigned to @ groups according to the adhesive system .", "the adhesive systems were applied to flat superficial coronal dentin surfaces etched with phosphoric acid and composite resin blocks were built up .", "the teeth were sectioned to produce beam-shaped specimens with @ mm@ cross-sectional area subjected to microtbs testing .", "microtbs data were analyzed statistically by anova and tukey 's test ( a = @ ) .", "the adhesive systems produced statistically similar mean microtbs to each other ( p > @ ) and no significant differences ( p > @ ) were found when the same material was applied to primary or permanent tooth dentin .", "the mean microtbs values ( mpa ) obtained were : prime & bond nt : @ + / - @ ( permanent ) and @ + / - @ ( primary ) ; single bond : @ + / - @ ( permanent ) and @ + / - @ ( primary ) ; excite dsc : @ + / - @ ( permanent teeth ) and @ + / - @ ( primary ) .", "there was no difference in the immediate microtbs of two-step etch-and-rinse adhesive systems when applied to the dentin of primary and permanent teeth ." ]

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

[ "pulp necrosis is one of the main complications of dental trauma .", "when it happens on an immature tooth , pulp necrosis implies a lack of root maturation and apical closure .", "a therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling .", "the aim of this prospective randomized clinical trial is to compare mineral trioxide aggregate ( mta ) with calcium hydroxide ( ch ) as materials used to induce root-end closure in necrotic permanent immature incisors .", "this study , promoted by ap-hp , was approved by the ethics committee ( cpp paris ile de france iv ) .", "@ children aged from @ to @ years and presenting a non-vital permanent incisor are selected .", "prior to treatment , an appropriate written consent has to be obtained from both parents and from children .", "patients are then randomly assigned to either the mta ( experimental ) or ch ( control ) groups .", "recalls are performed after @ , @ and @ months to determine the presence or absence of a calcified apical barrier through the use of clinical and radiographic exams .", "additional criteria such as clinical symptoms , apical radiolucencies , periapical index ( pai ) are also noted .", "clinicaltrials.gov no .", "nct@ ( first inclusion : may @ , @ ; last inclusion : april @ , @ ; study completed : april @ , @ ) ." ]

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

[ "the effects of induced hypothermia in cardiac surgical patients are not yet fully understood .", "despite numerous studies on the effects of acid-base management on organ blood flow , only little information is available on the effects of alpha-stat versus ph-stat management on systemic haemodynamics .", "we therefore compared the effect of alpha-stat and ph-stat acid-base management on systemic haemodynamics in a prospective , controlled , cross-over study .", "twenty patients undergoing coronary artery bypass surgery were included in the study .", "cardiac output was measured by thermodilution .", "cardiac index and systemic vascular resistance were calculated according to standard formulae .", "measurements were performed under hypo - and hypercapnia after induction of anaesthesia .", "measurements were repeated at the end of two @-min periods of ph-stat and alpha-stat acid-base management , respectively .", "systemic vascular resistance at the lower paco@-levels ( hypocapnia and alpha-stat , respectively ) was significantly higher than those at the higher level ( hypercania and ph-stat , respectively ) .", "the periods of different paco@-levels were comparable with respect to haematocrit , blood viscosity and temperature .", "systemic vascular resistance was not significantly different from the control period .", "this study demonstrates that during hypothermic cardiopulmonary bypass , systemic vascular resistance under alpha-stat acid-base management is higher than under ph-stat management .", "as obvious from measurements during the control period , this finding can be completely explained by the difference in paco@ ." ]

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

[ "epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type @ diabetes .", "we investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type @ diabetes who had either established cardiovascular disease or additional cardiovascular risk factors .", "in this randomized study , @,@ patients ( mean age , @ years ) with a median glycated hemoglobin level of @ % were assigned to receive intensive therapy ( targeting a glycated hemoglobin level below @ % ) or standard therapy ( targeting a level from @ to @ % ) .", "of these patients , @ % were women , and @ % had had a previous cardiovascular event .", "the primary outcome was a composite of nonfatal myocardial infarction , nonfatal stroke , or death from cardiovascular causes .", "the finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of @ years of follow-up .", "at @ year , stable median glycated hemoglobin levels of @ % and @ % were achieved in the intensive-therapy group and the standard-therapy group , respectively .", "during follow-up , the primary outcome occurred in @ patients in the intensive-therapy group , as compared with @ in the standard-therapy group ( hazard ratio , @ ; @ % confidence interval [ ci ] , @ to @ ; p = @ ) .", "at the same time , @ patients in the intensive-therapy group died , as compared with @ patients in the standard-therapy group ( hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) .", "hypoglycemia requiring assistance and weight gain of more than @ kg were more frequent in the intensive-therapy group ( p < @ ) .", "as compared with standard therapy , the use of intensive therapy to target normal glycated hemoglobin levels for @ years increased mortality and did not significantly reduce major cardiovascular events .", "these findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type @ diabetes .", "( clinicaltrials.gov number , nct@ . )" ]

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

[ "to determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections ( esi ) in patients with sciatica .", "we performed a @-month , multicentre , double-blind , randomized , placebo-controlled , parallel-group trial in four secondary pain-care clinics in the wessex region .", "two hundred and twenty-eight patients with a clinical diagnosis of unilateral sciatica of @-@ months ' duration were randomized to either three lumbar esis of triamcinolone acetonide or interligamentous saline injections at intervals of @ weeks .", "the main outcome measure was the oswestry low back pain disability questionnaire ( odq ) .", "at @ weeks , the esi group demonstrated a transient benefit over the placebo group ( patients achieving a @ % improvement in odq , @ vs @ % ; number needed to treat , @ ) .", "no benefit was demonstrated from @ to @ weeks .", "esis did not improve physical function , hasten return to work or reduce the need for surgery .", "there was no benefit of repeated esis over single injection .", "no clinical predictors of response were found .", "at the end of the study the majority of patients still had significant pain and disability regardless of intervention .", "in this pragmatic study , esis offered transient benefit in symptoms at @ weeks in patients with sciatica , but no sustained benefits in terms of pain , function or need for surgery .", "sciatica is a chronic condition requiring a multidisciplinary approach .", "to fully investigate the value of esis , they need to be evaluated as part of a multidisciplinary approach ." ]

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

[ "hyperkalemia is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system ( raas ) inhibitors with stage @ or greater chronic kidney disease ( ckd ) who may also have diabetes , heart failure , or both .", "to select starting doses for a phase @ study and to evaluate the long-term safety and efficacy of a potassium-binding polymer , patiromer , in outpatients with hyperkalemia .", "phase @ , multicenter , open-label , dose-ranging , randomized clinical trial ( amethyst-dn ) , conducted at @ sites in europe from june @ to june @ evaluating patiromer in @ outpatients with type @ diabetes ( estimated glomerular filtration rate , @ to < @ ml/min/@ @ m@ and serum potassium level > @ meq/l ) .", "all patients received raas inhibitors prior to and during study treatment .", "patients were stratified by baseline serum potassium level into mild or moderate hyperkalemia groups and received @ of @ randomized starting doses of patiromer ( @ g [ n = @ ] , @ g [ n = @ ] , or @ g [ n = @ ] twice daily [ mild hyperkalemia ] or @ g [ n = @ ] , @ g [ n = @ ] , or @ g [ n = @ ] twice daily [ moderate hyperkalemia ] ) .", "patiromer was titrated to achieve and maintain serum potassium level @ meq/l or lower .", "the primary efficacy end point was mean change in serum potassium level from baseline to week @ or prior to initiation of dose titration .", "the primary safety end point was adverse events through @ weeks .", "secondary efficacy end points included mean change in serum potassium level through @ weeks .", "a total of @ patients were randomized .", "the least squares mean reduction from baseline in serum potassium level at week @ or time of first dose titration in patients with mild hyperkalemia was @ ( @ % ci , @-@ @ ) meq/l for the @ g twice daily starting-dose group , @ ( @ % ci , @-@ @ ) meq/l for the @ g twice daily starting-dose group , and @ ( @ % ci , @-@ @ ) meq/l for the @ g twice daily starting-dose group .", "in those with moderate hyperkalemia , the reduction was @ ( @ % ci , @-@ @ ) meq/l for the @ g twice daily starting-dose group , @ ( @ % ci , @-@ @ ) meq/l for the @ g twice daily starting-dose group , and @ ( @ % ci , @-@ @ ) meq/l for the @ g twice daily starting-dose group ( p < @ for all changes vs baseline by hyperkalemia starting-dose groups within strata ) .", "from week @ through week @ , statistically significant mean decreases in serum potassium levels were observed at each monthly point in patients with mild and moderate hyperkalemia .", "over the @ weeks , hypomagnesemia ( @ % ) was the most common treatment-related adverse event , mild to moderate constipation ( @ % ) was the most common gastrointestinal adverse event , and hypokalemia ( < @ meq/l ) occurred in @ % of patients .", "among patients with hyperkalemia and diabetic kidney disease , patiromer starting doses of @ to @ g twice daily resulted in statistically significant decreases in serum potassium level after @ weeks of treatment , lasting through @ weeks .", "clinicaltrials.gov identifier : nct@ ." ]

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

[ "for patients with cancer who are married or in an intimate relationship , their relationships with their partners play a critical role in their adaptation to illness .", "however , cancer patients and their partners often have difficulty in talking with each other about their cancer-related concerns .", "difficulties in communication ultimately may compromise both the patient-partner relationship and the patient 's psychological adjustment .", "the current study tested the efficacy of a novel partner-assisted emotional disclosure intervention in a sample of patients with gastrointestinal ( gi ) cancer .", "one hundred thirty patients with gi cancer and their partners were assigned randomly to receive @ sessions of either partner-assisted emotional disclosure or a couples cancer education/support intervention .", "patients and partners completed measures of relationship quality , intimacy with their partner , and psychological distress before randomization and at the end of the intervention sessions .", "data were analyzed using multilevel modeling .", "compared with an education/support condition , the partner-assisted emotional disclosure condition led to improvements in relationship quality and intimacy for couples in which the patient initially reported higher levels of holding back from discussing cancer-related concerns .", "partner-assisted emotional disclosure is a novel intervention that builds on both the private emotional disclosure and the cognitive-behavioral marital literature .", "the results of this study suggested that this intervention may be beneficial for couples in which the patient tends to hold back from discussing concerns .", "the authors concluded that future research on methods of enhancing the effects of partner-assisted emotional disclosure is warranted ." ]

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

[ "this study was undertaken to examine whether acupuncture treatment may have a long-term effect on smoking cessation or reduction .", "altogether @ healthy men and women who reported smoking @ + / - @ cigarettes per day ( mean + / - sd ) volunteered in the study .", "they were randomly assigned to a test group ( tg ) or to a control group ( cg ) in which presumed anti-smoking acupoints were stimulated ( tg ) or acupuncture was applied to acupoints considered to have no effect on smoking cessation ( cg ) .", "before each treatment , after the last one , and @ months and @ years after the last one , each subject answered questionnaires about his or her smoking habits and attitudes .", "blood samples for measuring variables related to smoking , i.e. , serum cotinine and serum thiocyanate , were taken .", "during the treatment period the reported cigarette consumption fell on average by @ ( tg ) and @ ( cg ) cigarettes per day ( p < @ ) .", "for both groups the reported cigarette consumption rose on average by @-@ cigarettes during the following @ months , and there was no systematic change thereafter .", "consequently , tg showed a maintained reduction in smoking ; no lasting effect was seen for cg .", "the tg reported that cigarettes tasted worse than before the treatments , and also the desire to smoke fell .", "for tg the serum concentration of cotinine fell , and the values correlated with the reported smoking .", "this study confirms that adequate acupuncture treatment may help motivated smokers to reduce their smoking , or even quit smoking completely , and the effect may last for at least @ years .", "acupuncture may affect the subjects ' smoking by reducing their taste of tobacco and their desire to smoke .", "different acupoints have different effects on smoking cessation ." ]

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

[ "to assess the safety of vivagel used vaginally twice daily for @ days among healthy , sexually-abstinent women , aged @-@ years in the usa and kenya .", "randomized placebo controlled trial .", "participants were randomized @ , vivagel to placebo .", "safety was assessed by comparing genitourinary ( gu ) adverse events ( aes ) , colposcopy findings , vaginal lactobacilli and laboratory abnormalities by arm .", "fifty-four women were enrolled ; @ in the vivagel arm and @ in the placebo arm .", "twenty-six ( @ % ) and @ ( @ % ) women reported taking all doses of vivagel and placebo , respectively .", "no grade @ or @ aes , or serious aes occurred .", "twenty-five ( @ % ) participants in the vivagel arm compared to @ ( @ % ) participants in the placebo arm had at least one grade @ or @ gu ae associated with product use ( rr = @ , @ % ci @-@ @ ) .", "all seven grade @ gu aes associated with product use occurred among four women in the vivagel arm .", "vulvar and cervical erythema , cervical lesions , symptomatic bv , urinary frequency and metrorrhagia were more common in the vivagel arm than the placebo arm .", "twenty-nine ( @ % ) participants in the vivagel arm had a colposcopic finding compared to @ ( @ % ) participants in the placebo arm ( rr = @ , @ % ci = @-@ @ ) .", "two women in the vivagel arm prematurely discontinued product use themselves due to a reported gu ae .", "persistence of ho-producing and non-producing lactobacilli did not differ by study arm .", "gu aes and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the vivagel arm .", "clinicaltrials.gov nct@ ." ]

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

[ "student nurses are an important target group for smoking prevention .", "this study analyzes ( a ) the relation between student nurses ' smoking behavior and their knowledge , attitudes , and behavior toward smoking prevention and ( b ) the effect of targeted health education in improving student nurses ' knowledge , attitudes , and preventive behavior .", "a controlled trial was performed with school classes as the randomization unit .", "one hundred fifty-five first-year students from a school in nursing in copenhagen , denmark , participated in a baseline study and a follow-up study @ weeks later .", "the intervention included eight lectures on the health consequences of smoking .", "about @ % of student nurses in both the intervention and the control groups were smokers , and this percentage did not change during follow-up .", "compared with nonsmokers , smokers had less favorable attitudes and behavior toward smoking prevention .", "student nurses ' knowledge about the health consequences of smoking improved during the study period in both groups , but the change was larger in the intervention group .", "this difference was not present in multivariate analyses that controlled for age and smoking status .", "during follow-up the attitude improved in the intervention classes , while it deteriorated in the controls , revealing a significant difference , which persisted after multivariate adjustment .", "the amount of education had no effect on student nurse 's preventive behavior .", "targeted health education improves knowledge and attitudes toward smoking prevention in first-year student nurses ." ]

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

[ "dihydrocodeine is metabolized to dihydromorphine via the isoenzyme cytochrome p@ @d@ , whose activity is determined by genetic polymorphism .", "the importance of the dihydromorphine metabolites for analgesia in poor metabolizers is unclear .", "the aim of this study was to assess the importance of the dihydromorphine metabolites of dihydrocodeine in analgesia by investigating the effects of dihydrocodeine on somatic and visceral pain thresholds in extensive and quinidine-induced poor metabolizers .", "eleven healthy subjects participated in a double-blind , randomized , placebo-controlled , four-way cross-over study comparing the effects of single doses of placebo and slow-release dihydrocodeine @ mg with and without premedication with quinidine sulphate @ mg on electrical , heat and rectal distension pain tolerance thresholds .", "plasma concentrations and urinary excretion of dihydrocodeine and dihydromorphine were measured .", "in quinidine-induced poor metabolizers the plasma concentrations of dihydromorphine were reduced between @ and @ fold from @ h to @ h after dosing ( p < @ ) and urinary excretion of dihydromorphine in the first @ h was decreased from @ % to @ % of the dihydrocodeine dose ( p < @ ) .", "dihydrocodeine significantly raised the heat pain tolerance thresholds ( at @ h and @ h postdosing , p < @ ) and the rectal distension defaecatory urge ( at @ h and @ h postdosing , p < @ ) and pain tolerance thresholds ( at @ h and @ h postdosing , p < @ ) compared with placebo .", "premedication with quinidine did not change the effects of dihydrocodeine on pain thresholds , but decreased the effect of dihydrocodeine on defaecatory urge thresholds ( at @ h , @ h and @ h postdosing , p < @ ) .", "in quinidine-induced poor metabolizers significant reduction in dihydromorphine metabolite production did not result in diminished analgesic effects of a single dose of dihydrocodeine .", "the metabolism of dihydrocodeine to dihydromorphine may therefore not be of clinical importance for analgesia .", "this conclusion must however , be confirmed with repeated dosing in patients with pain ." ]

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

[ "the consequences of alcohol dependence are severe and may range from physical disease to neuropsychological deficits in several cognitive domains .", "alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex .", "conventional neuropsychological interventions ( paper-and-pencil cognitive stimulation training ) have a positive effect but are time-consuming , costly , and not motivating for patients .", "our goal was to test the cognitive effects of a novel approach to neuropsychological intervention , using mobile technology and serious games , on patients with alcohol dependence .", "the trial design consisted of a two-arm study assessing the cognitive outcomes of neuropsychological intervention with mobile serious games ( mhealth ) versus control ( treatment-as-usual with no neuropsychological intervention ) in patients undergoing treatment for alcohol dependence syndrome .", "sixty-eight patients were recruited from an alcohol-rehab clinic and randomly assigned to the mhealth ( n = @ ) or control condition ( n = @ ) .", "the intervention on the experimental group consisted of a therapist-assisted cognitive stimulation therapy for @ weeks on a @-@ days/week basis .", "fourteen patients dropped out of the study .", "the results of the neuropsychological assessments with the remaining @ patients showed an overall increase ( p < @ ) of general cognitive abilities , mental flexibility , psychomotor processing speed , and attentional ability in both experimental ( n = @ ) and control groups ( n = @ ) .", "however , there was a more pronounced improvement ( p = @ ) specifically in frontal lobe functions from baseline ( mean @ , se @ ) to follow-up ( mean @ , se @ ) in the experimental group but not in the control group .", "the overall increase in general cognitive function for both experimental and control groups supports the beneficial role of existing alcohol treatment protocols aimed at minimizing withdrawal symptoms , but the differential improvements observed in frontal lobe functioning supports the use of mobile serious games for neuropsychological stimulation to overcome executive dysfunction in patients with alcohol dependence .", "this trial was negative on two neuropsychological/cognitive tests , and positive on one .", "clinicaltrials.gov nct@ ; http://www.clinicaltrials.gov/ct@/show/nct@ ." ]

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

[ "to compare the safety and immunogenicity of @ different acellular pertussis vaccines combined with diphtheria and tetanus toxoids ( dtap ) with one licensed diphtheria , tetanus , and whole-cell pertussis vaccine ( dtwp ) as a fourth-dose booster in children who had previously received dtap or dtwp primary vaccinations .", "healthy @ - to @-month-old children were enrolled at six national institutes of health vaccine treatment and evaluation units .", "all had been randomly assigned to receive three primary doses of dtap or dtwp at @ , @ , and @ months of age as part of an earlier national institutes of health multicenter trial of dtap vaccines in the same vaccine treatment and evaluation units .", "parents recorded the occurrence and magnitude of fever ; irritability ; and injection site redness , swelling , and pain for @ days after vaccination .", "sera obtained before and @ month after the booster vaccination were analyzed for antibody to pertussis toxin ( pt ) , filamentous hemagglutinin ( fha ) , fimbriae ( fim ) , and pertactin ( prn ) .", "diphtheria and tetanus toxoid as well as pt neutralizing ( chinese hamster ovary cell ) and whole-cell agglutinating antibodies were measured on a subset of sera .", "a total of @ children contributed fourth-dose reaction data .", "reactions were less frequent after dtap than after dtwp .", "for children vaccinated with a fourth dose of dtap , which was the same dtap as received in the primary series , fever and injection site redness , swelling , and pain increased in prevalence compared with the third dose in the primary series .", "for children receiving dtap as a fourth dose , injection site redness and swelling occurred more frequently in dtap-primed than in dtwp-primed children .", "variation in the occurrence of reactions among dtap vaccines was observed .", "a total of @ paired pre - and postvaccination sera were available for analysis .", "serum antibody concentrations before boosting were lower than those obtained @ month after the primary immunization .", "after the fourth dose , significant increases in antibodies directed against the included antigens were observed for all vaccines ; postbooster vaccination antibody titers differed significantly among the dtap vaccines .", "for children primed and boosted with the same dtap , antibody levels were not directly related to the quantity of antigen included for pt , fha , and fim ; for prn , there was a closer relationship .", "some dtap vaccines given as fourth-dose boosters elicited antibody to prn or fim in some vaccinees , although the dtap vaccines were not reported to contain these antigens ; these responses were observed more frequently in dtwp-primed children .", "agglutinin antibody rises were observed in all groups immunized with four doses of a dtap vaccine containing fha or prn , regardless of whether the vaccine included fim .", "diphtheria and tetanus antibody levels exceeded the presumed protective concentration ( @ iu/ml for diphtheria and @ iu/ml for tetanus ) after the fourth dose for all vaccinees .", "although differences were observed in reaction rates among the dtap vaccines given as a fourth dose , the dtap vaccines were , in general , associated with fewer adverse events than a us-licensed dtwp .", "for dtap vaccines , fever ; irritability ; and injection site pain , redness , and swelling occurred more frequently after the fourth dose than after the third dose of the same vaccine in the primary series .", "no dtap was consistently most or least reactogenic or immunogenic .", "although serologic correlates of pertussis immunity are not defined , it is clear that most dtap vaccines can stimulate comparable or higher serum antibody responses than dtwp for those antigens contained in the vaccine ." ]

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

[ "to evaluate effects of infusion of guaifenesin , ketamine , and medetomidine in combination with inhalation of sevoflurane versus inhalation of sevoflurane alone for anesthesia of horses .", "randomized clinical trial .", "@ horses .", "horses were premedicated with xylazine and anesthetized with diazepam and ketamine .", "anesthesia was maintained by infusion of guaifenesin , ketamine , and medetomidine and inhalation of sevoflurane ( @ horses ) or by inhalation of sevoflurane ( @ horses ) .", "a surgical plane of anesthesia was maintained by controlling the inhaled concentration of sevoflurane .", "sodium pentothal was administered as necessary to prevent movement in response to surgical stimulation .", "hypotension was treated with dobutamine ; hypoxemia and hypercarbia were treated with intermittent positive-pressure ventilation .", "the quality of anesthetic induction , maintenance , and recovery and the quality of the transition to inhalation anesthesia were scored .", "the delivered concentration of sevoflurane ( ie , the vaporizer dial setting ) was significantly lower and the quality of transition to inhalation anesthesia and of anesthetic maintenance were significantly better in horses that received the guaifenesin-ketamine-medetomidine infusion than in horses that did not .", "five horses , all of which received sevoflurane alone , required administration of pentothal .", "recovery time and quality of recovery were not significantly different between groups , but horses that received the guaifenesin-ketamine-medetomidine infusion required fewer attempts to stand .", "results suggest that in horses , the combination of a guaifenesin-ketamine-medetomidine infusion and inhalation of sevoflurane resulted in better transition and maintenance phases while improving cardiovascular function and reducing the number of attempts needed to stand after the completion of anesthesia , compared with inhalation of sevoflurane ." ]

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

[ "this study explored possible mechanisms through which symptoms of posttraumatic stress disorder ( ptsd ) were reduced in a randomized controlled trial comparing the effect of a yoga intervention with an assessment control .", "we examined whether changes in psychological flexibility , mindfulness , and emotion regulation strategies ( expressive suppression and reappraisal ) were associated with posttreatment ptsd symptoms for @ women with diagnostic and statistical manual of mental disorders fourth edition full or subthreshold ptsd .", "hierarchical linear regression models revealed that expressive suppression significantly decreased for the yoga group relative to the assessment control .", "psychological flexibility increased significantly for the control but not yoga group .", "however , increases in psychological flexibility were associated with decreases in ptsd symptoms for the yoga but not control group .", "preliminary findings suggest that yoga may reduce expressive suppression and may improve ptsd symptoms by increasing psychological flexibility .", "more research is needed to replicate and extend these findings ." ]

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

[ "there are currently no clinically useful assessments that can reliably predict -- early in treatment -- whether a particular depressed patient will respond to a particular antidepressant .", "we explored the possibility of using baseline features and early symptom change to predict which patients will and which patients will not respond to treatment .", "participants were @,@ outpatients enrolled in the sequenced treatment alternatives to relieve depression ( star * d ) study who had complete @-item quick inventory of depressive symptomatology-self-report ( qids-sr@ ) records at baseline , week @ , and week @ ( primary outcome ) of treatment with citalopram .", "response was defined as a @ % reduction in qids-sr@ score by week @ .", "by developing a recursive subsetting algorithm , we used both baseline variables and change in qids-sr@ scores from baseline to week @ to predict response/nonresponse to treatment for as many patients as possible with controlled accuracy , while reserving judgment for the rest .", "baseline variables by themselves were not clinically useful predictors , whereas symptom change from baseline to week @ identified @ nonresponders , of which @ were true nonresponders .", "by subsetting recursively according to both baseline features and symptom change , we were able to identify @ nonresponders , of which @ were true nonresponders , to achieve a clinically meaningful negative predictive value of @ , which was upheld in cross-validation analyses .", "recursive subsetting based on baseline features and early symptom change allows predictions of nonresponse that are sufficiently certain for clinicians to spare identified patients from prolonged exposure to ineffective treatment , thereby personalizing depression management and saving time and cost .", "clinicaltrials.gov identifier : nct@ ." ]

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

[ "our purpose was to determine whether maternal administration of prophylactic ampicillin or erythromycin after preterm amnion rupture is associated with maternal or neonatal benefits .", "women with singleton pregnancies between @ and @ weeks @ days of gestation were eligible if they had no immediate indication for delivery .", "after giving informed consent , patients were randomized either to receive ampicillin ( erythromycin if penicillin allergic ) until delivery or to enter a control group .", "women whose cervical cultures were positive for either group b streptococci or neisseria gonorrhoeae received treatment .", "tocolytics and corticosteroids were not used .", "from january @ to february @ @ patients ( antibiotics @ , control @ ) were recruited and analyzed .", "prophylactic antibiotics were associated with a longer latent phase ( mean @ vs @ days , p = @ ) and fewer maternal infectious complications ( @ % vs @ % , p = @ ) .", "a higher incidence of neonatal necrotizing enterocolitis was observed in the treatment group ( @ % vs @ % , p = @ ) .", "other neonatal complications , including death , were lower in the treatment group , but none attained statistical significance ( p = @ to @ ) .", "the use of prophylactic antibiotics in selected patients after preterm amnion rupture appears to have a demonstrable maternal benefit .", "large , multicenter trials may demonstrate a significant neonatal benefit or confirm any adverse outcomes ." ]

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

[ "to compare neonatal short-term outcome in patients who underwent spinal , general anaesthesia and conversion from spinal to general anaesthesia .", "one hundred seventy-nine pregnant women undergoing elective caesarean section were allocated randomly to general ( n = @ ) or spinal anaesthesia ( n = @ ) and compared with @ patients who required conversion to general anaesthesia .", "umbilical cord artery ph , apgar score as well as its individual parameter and need for assisted ventilation were evaluated .", "no differences were found in ph values ( p = @ ) , while the need for assisted ventilation differed significantly ( p = @ ) .", "the rate of depressed newborns was @ % in the spinal group , @ % in the general group and @ % in the conversion group with a significant difference for all comparisons .", "at @-min , all newborns were vigorous .", "at @min , a higher score for each parameter was found in spinal group with respect to general group , while ` activity ' , ` grimace ' and ` respiration ' showed a higher score in conversion group than in general group .", "at @min , a difference was found only for ` activity ' .", "all kinds of anaesthesia seem to be safe , but loco-regional blockade shows more advantages on the neonatal outcome also when a conversion is necessary ." ]

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

[ "to compare the clinical and radiological outcomes following two different , single visit vital pulp therapy techniques , in cariously exposed primary molar teeth .", "a paediatric dental clinic within the dental hospital , newcastle upon tyne , uk .", "fifty two child patients were sequentially enrolled in the clinical investigation , @ males and @ females with an age range of @-@ @ years .", "primary molar teeth requiring vital pulp therapy were randomly allocated to either the formocresol group ( f ) or the calcium hydroxide group ( c ) .", "the total number of teeth treated was @ .", "recruitment was on the basis of strict inclusion criteria .", "coronal pulp amputation was prescribed only in teeth with vital , cariously exposed pulp tissue .", "treatment was undertaken between october @ and december @ .", "all cases were reviewed using predefined clinical and radiological criteria .", "the statistical tests used were logistic regression of a triple nested data structure , chi-squared analysis of equality of treatment and probability of success with relation to subject age .", "eighty-four cariously exposed primary molars required vital pulp therapy .", "forty six ( @ % ) teeth were included in the f group and @ ( @ % ) allocated to the c group .", "five teeth were lost to follow-up , leaving @ teeth : forty four ( @ % ) in group f and @ ( @ % ) in group c. eighty four percent ( @/@ ) of teeth treated with formocresol and @ percent ( @/@ ) treated with calcium hydroxide were classed as clinically and radiographically successful at the cut-off date , december @ , after a mean clinical review of @ months ( range @-@ @ months ) and a mean radiographic review of @ months ( range @-@ @ months ) .", "this investigation confirms the clinical efficacy of a one-fifth dilution of buckley 's formocresol as an agent in pulp treatment of cariously exposed , vital primary molar teeth .", "however , calcium hydroxide in its pure , powder form is a clinically acceptable alternative when combined with strict selection criteria for this method of restorative care .", "there was a statistically insignificant difference in successful clinical and radiological outcome between the two treatment groups .", "success was unrelated to the duration of time taken to achieve haemostasis and the presence or absence of bleeding after placement of the medicament ." ]

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

[ "to compare the efficacy of verapamil and diltiazem as slow infusions in terminating spontaneous supraventricular tachycardia ( svt ) in the emergency department ( ed ) .", "patients of at least @ years of age who presented to our ed with regular narrow complex tachycardia not converted with a vagal manoeuvre with an ecg diagnosis of svt were included .", "those who were haemodynamically unstable were excluded .", "patients were randomized to undergo either verapamil infusion at a rate of @ mg/min to a maximum of @ mg or diltiazem infusion at a rate of @ mg/min to a maximum of @ mg .", "eighty-one patients were randomized to receive verapamil infusion and @ were randomized to receive the diltiazem infusion .", "there is no difference in success rate between verapamil ( @ % ) and diltiazem ( @ % ) infusion .", "the dose of medication required to convert @,@ and @ % of svts were @,@ and @ mg for the verapamil infusion and @,@ and @ mg for the diltiazem infusion .", "there was one complication in each group .", "calcium channel blockers infusions were safe and efficacious in terminating spontaneous svt .", "there was no difference between the success rates of verapamil and diltiazem infusions ." ]

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

[ "to compare the efficacy and safety of a @-day regimen of clindamycin vaginal ovules with a @-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis ( bv ) .", "women with a clinical diagnosis of bv were treated with a @-day course of clindamycin ovules or a @-day course of clindamycin cream administered intravaginally .", "three hundred and eighty-four patients received study drug and were included in the evaluable patient population ( ovule group , n = @ ; cream group , n = @ ) .", "assessments included pelvic examination and diagnostic testing .", "primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second .", "cure rates in the evaluable patient population were similar between treatment groups : @ % ( @/@ ) for the ovule group and @ % ( @/@ ) for the cream group ( p = @ , @ % ci -@ -@ % ) .", "the most commonly reported medical event , vulvovaginal pruritus , had similar incidence in both treatment groups .", "a @-day course of clindamycin vaginal ovules is as effective and well-tolerated as a @-day course of clindamycin vaginal cream in the treatment of bv ." ]

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

[ "numerous studies have indicated an association between spirituality and health outcomes .", "however , little information is available about interventions that have been shown to enhance spiritual health and decrease stress .", "this study examined the effects of a spiritual learning program ( slp ) on nursing student-perceived spiritual health and clinical practice stress .", "a convenience sample of nursing students currently enrolled at a nursing school in northern taiwan were recruited to participate in this quasiexperimental study as participants to experimental and control groups via simple random sampling .", "results from a spiritual health scale and a perceived clinical practice stress scale , together with the score for clinical nursing practice , were compared between the groups .", "baseline data were collected from all participants .", "the experimental group participated in @ weeks of @-minute per week slp , which included lectures , discussion , reflection , and spiritual practices .", "a second data set was collected from all participants after the intervention .", "a third data set was collected after all participants had performed @ weeks of nursing clinical practice .", "participants were all women .", "average age was @ years ( sd = @ years ) .", "generalized estimating equation analysis showed slp to have a significant short-term effect on improving the total score for spiritual health ( p < @ ) .", "significantly greater improvement in clinical practice stress scores was also seen in the experimental group as compared with the control group ( all p < @ ) .", "the experimental group obtained a higher score of the final clinical practice than the control group ( t = @ , p < @ ) .", "the slp may encourage participants to see stressors as meaningful events that are connected to individual life purposes .", "the program developed in this study may be used to improve spiritual health and reduce stress in nursing students ' clinical practice .", "this slp may be referenced when designing similar spirituality-related courses and applied to nursing student counseling ." ]

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

[ "multicenter , randomized , double-blind , placebo-controlled trial .", "to examine the safety and efficacy of three different doses of the tumor necrosis factor alpha ( tnf - ) inhibitor etanercept versus placebo for the treatment of symptomatic lumbar disc herniation ( ldh ) .", "tnf - is considered to be a major cause of radicular leg pain associated with symptomatic ldh .", "systemic administration of tnf - inhibitors for sciatica has indicated a trend toward efficacy .", "forty-nine subjects aged between @ and @ years , with persistent lumbosacral radicular pain secondary to ldh , and an average leg pain intensity of @/@ or more were randomized to @ of @ groups : @-mg , @-mg , @-mg etanercept , or placebo .", "subjects received @ transforaminal epidural injections , @ weeks apart , and were assessed for efficacy up to @ weeks after the second injection .", "the primary outcome measure was the change in mean daily worst leg pain ( wlp ) .", "secondary outcomes included average leg pain , worst back pain , average back pain , in-clinic pain , oswestry disability index , patient global impression of change , and tolerability .", "forty-three of the @ randomized patients completed the study .", "patients receiving @-mg etanercept showed a clinically and statistically significant ( p < @ ) reduction in mean daily wlp compared with the placebo cohort from @ to @ weeks for both the per protocol population ( -@ vs. -@ ; p = @ ) and the intention-to-treat population ( -@ vs. -@ ; p = @ ) .", "fifty percent of these subjects reported a @ % reduction in wlp @ weeks post-treatment compared with @ % of subjects in the placebo cohort .", "improvements in all secondary outcomes were also observed in the @-mg etanercept cohort .", "the overall incidence of adverse events was similar in placebo and all etanercept cohorts .", "two transforaminal injections of etanercept provided clinically significant reductions in mean daily wlp and worst back pain compared with placebo for subjects with symptomatic ldh .", "epidural etanercept may offer patients with sciatica a safe and effective nonoperative treatment ." ]

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

[ "the aim of this pilot study was to determine whether early atorvastatin treatment will reduce left ventricle ( lv ) remodeling , infarct size , and improve microvascular perfusion .", "in animal studies , early statin therapy reduces reperfusion injury after a percutaneous coronary intervention ( pci ) for acute myocardial infarction ( ami ) .", "forty-two consecutive patients ( @ % male , mean age @ @ ) who underwent a primary pci for a first st-elevated ami were randomized for pretreatment with atorvastatin @ mg ( n = @ ) or placebo ( n = @ ) and continued with the same dosage daily for @ week .", "all patients received atorvastatin @ mg once daily @ days after primary pci .", "the lv function and infarct size were measured by magnetic resonance imaging within @ day , at @ week , and @ months follow up .", "the primary endpoint was the end-systolic volume index ( esvi ) at @ months .", "secondary endpoints were global lv function measurements , myocardial infarct size , biochemical cardiac markers , timi flow , and st-t elevation resolution .", "esvi @ months after ami was @ ml/m ( @ ) in the atorvastatin arm and @ ml/m ( @ ) in the placebo arm ( p = @ ) .", "the differences in change from baseline to @ months follow up in global lv function and myocardial infarct size did not differ between both treatment arms .", "furthermore , biochemical markers , timi flow , and st-t elevation resolution did not differ between atorvastatin and placebo arm .", "in this pilot study , pretreatment with atorvastatin in an acute myocardial infarction does not result in an improved cardiac function , microvascular perfusion , or decreased myocardial infarct size ." ]

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

[ "to characterize effects of bivalirudin compared with unfractionated heparin plus eptifibatide on inflammation , and thrombin generation and activity after percutaneous coronary intervention .", "we measured the concentration in blood of fibrinopeptide a , prothrombin fragment @ +@ , soluble cd@ ligand , interleukin @ receptor antagonist , interleukin @ , and high sensitivity c-reactive protein in @ patients treated with aspirin and clopidogrel and undergoing elective percutaneous coronary intervention , who were randomized to treatment with either bivalirudin ( n = @ ) or unfractionated heparin plus eptifibatide ( n = @ ) .", "neither generation nor activity of thrombin increased @ min after percutaneous coronary intervention in patients randomized to bivalirudin or unfractionated heparin plus eptifibatide .", "however , prothrombin fragment @ +@ increased modestly and comparably in both groups after @ day .", "inflammation , reflected by concentrations of interleukin @ and high sensitivity c-reactive protein in blood , increased similarly @ day after percutaneous coronary intervention in patients treated with either regimen .", "in a subset of patients ( n = @ in each group ) from whom blood was obtained @ days after percutaneous coronary intervention , the concentration of high sensitivity c-reactive protein was lower in those who had been treated with bivalirudin ( by @ mg/l , p = @ ) .", "the early effects on inflammation and thrombin generation and activity are similar after treatment with bivalirudin alone compared with unfractionated heparin plus eptifibatide in patients treated with aspirin and clopidogrel who are undergoing percutaneous coronary intervention for symptoms of stable angina .", "the decreased concentration of high sensitivity c-reactive protein seen @ days after percutaneous coronary intervention in those treated with bivalirudin is consistent with greater attenuation of inflammation that may have contributed to the trend toward reduced mortality @ year later in those treated with bivalirudin in replace-@ ." ]

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

[ "endoscopic heater probe thermocoagulation and hemoclip are considered to be safe and very effective in the treatment of bleeding peptic ulcer .", "so far , there are only few reports concerning hemostasis with endoscopic hemoclip .", "the aims of this study were to compare the hemostatic effects of both therapeutic modalities in patients with peptic ulcer bleeding .", "a total of @ patients with active bleeding or nonbleeding visible vessels were randomized to receive endoscopic hemoclip ( n = @ ) or heater probe thermocoagulation ( n = @ ) .", "initial hemostasis was achieved in @ patients ( @ % ) in the hemoclip group and @ patients ( @ % ) in the heater probe group ( p = @ ) .", "rebleeding occurred in three patients ( @ % ) in the hemoclip group and two patients ( @ % ) in the heater probe group ( p > @ ) .", "among patients with difficult-to-approach bleeding , we obtained a better hemostatic rate in the heater probe group ( nine of @ patients vs three of @ , p = @ ) .", "the volume of blood transfused after entry into the study , duration of hospital stay , number of patients requiring urgent surgery , and the mortality rate were not statistically significantly different between the two groups .", "for patients with peptic ulcer bleeding , heater probe thermocoagulation offers an advantage in achieving hemostasis than hemoclip .", "in difficult-to-approach bleeders , heater probe is a more suitable therapeutic modality ." ]

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

[ "the aim of this study was to compare a fixed-sample and a sequential design with regard to study duration , sample size , and medical results in a real-life situation .", "a randomized study comparing laparoscopic and conventional cholecystectomy was carried out with a fixed-sample design , parallel with a sequential design .", "the main variable was duration of postoperative convalescence .", "in the fixed-sample trial the necessary number of patients was calculated to be @ .", "the sequential trial was conclusive after inclusion of @ patients and reduced the duration of the study from @ to @ weeks .", "additionally , the sequential trial reached the same conclusions as the fixed-sample trial in all the observed variables except for one .", "the present study indicates that sequential design should be used more frequently in clinical trials , to involve the smallest possible number of patients necessary to reach a conclusion ." ]

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

[ "total enteral nutrition ( ten ) with a liquid formula can suppress gut inflammation and induce remission in active crohn 's disease .", "the mechanism is obscure .", "studies have suggested that long term nutritional supplementation with a liquid formula ( partial enteral nutrition ( pen ) ) may also suppress inflammation and prevent relapse .", "the aim of this study was to compare pen with conventional ten in active crohn 's disease .", "fifty children with a paediatric crohn 's disease activity index ( pcdai ) > @ were randomly assigned to receive @ % ( pen ) or @ % ( ten ) of their energy requirement as elemental formula for six weeks .", "the pen group was encouraged to eat an unrestricted diet while those receiving ten were not allowed to eat .", "the primary outcome was achievement of remission ( pcdai < @ ) .", "secondary analyses of changes in erythrocyte sedimentation rate ( esr ) , c reactive protein , albumin , and platelets were performed to look for evidence of anti-inflammatory effects .", "remission rate with pen was lower than with ten ( @ % v @ % ; p = @ ) .", "although pcdai fell in both groups ( p = @ for both ) , the reduction was greater with ten ( p = @ ) .", "moreover , the fall in pcdai with pen was due to symptomatic and nutritional benefits .", "with both treatments there were significant improvements in relation to abdominal pain , `` sense of wellbeing '' , and nutritional status .", "however , only ten led to a reduction in diarrhoea ( p = @ ) , an increase in haemoglobin and albumin , and a fall in platelets and esr .", "ten suppresses inflammation in active crohn 's disease but pen does not .", "this suggests that long term nutritional supplementation , although beneficial to some patients , is unlikely to suppress inflammation and so prevent disease relapse ." ]

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

[ "smoking may affect adversely the cure rate for helicobacter pylori infection in patients treated with amoxicillin and omeprazole .", "therapy with clarithromycin and omeprazole was tested for its effectiveness in the treatment of h. pylori infection in smokers and nonsmokers .", "patients with verified duodenal ulcer and h. pylori infection received clarithromycin @ mg tid , in combination with omeprazole @ mg / day , for @ weeks , followed by omeprazole ( @ or @ mg daily ) for @ additional weeks according to a randomized , double-blind , multicenter design .", "patients were analyzed by their smoking status for the cure of h. pylori infection , ulcer healing , and prevention of duodenal ulcer recurrence .", "after treatment with clarithromycin and omeprazole , h. pylori infection was cured in @ % of the smokers and in @ % of the nonsmokers ( evaluated @-@ weeks after treatment ) .", "overall ulcer healing was @ % , and overall ulcer recurrence was @ % .", "for h. pylori-negative patients , ulcer recurrence was @ % in both smokers and nonsmokers .", "none of these values was significantly different when smokers were compared to nonsmokers .", "therapy with clarithromycin and omeprazole is effective for cure of h. pylori infection in smokers and nonsmokers .", "smoking has no effect on duodenal ulcer healing or duodenal ulcer recurrence for patients treated with this regimen ." ]

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

[ "previous studies have not demonstrated good correlations between various presumed phenotypic measures of in vivo cytochrome p@ ( cyp ) @a activity .", "however , in reality , few have used appropriate and validated in vivo probes that consider the complexities of cyp@a .", "accordingly , the disposition of @ closely related benzodiazepines with extensive and similar cyp@a-mediated metabolism characteristics but different pharmacokinetics was investigated , and correlations between the drugs were examined .", "the single-dose oral clearances of alprazolam , midazolam , and triazolam and the systemic clearances of the latter @ drugs were separately determined in @ healthy subjects ( @ men ) according to a randomized experimental design with a minimum @-week period between the individual studies .", "an erythromycin breath test was also performed .", "after intravenous administration , systemic clearance varied @-fold compared with a @-fold range in clearance after an oral dose for all @ drugs .", "however , mean values differed markedly between the drugs , with the systemic clearance of midazolam being almost double that of triazolam ( @ + / - @ ml/min versus @ + / - @ ml/min ) .", "oral clearances were even more dissimilar : alprazolam , @ + / - @ ml/min ; triazolam , @ + / - @ ml/min ; and midazolam , @ + / - @ ml/min .", "estimates of cyp@a-mediated extraction by the intestine and liver indicated approximately equal contributions by both organs but larger values for midazolam than for triazolam , and these differences accounted for the differences in oral bioavailability , @ % + / - @ % versus @ % + / - @ % , respectively .", "statistically significant ( p = @ to @ ) correlations between the @ drugs ' oral clearances ranged from @ to @ ( r s value ) , whereas the correlation for the systemic clearances of midazolam and triazolam was @ ( p = @ ) .", "no statistically significant relationships were observed between any of the clearance parameters and the erythromycin breath test .", "despite alprazolam , midazolam , and triazolam having markedly different pharmacokinetic characteristics , statistically significant correlations were present between the oral and systemic clearances of the @ drugs , consistent with a major involvement of cyp@a in their metabolism and elimination .", "however , the magnitude of the coefficients of determination ( r s ) was such to suggest that an in vivo probe approach , even with the use of valid phenotypic trait values , will be unable to accurately and reliably predict the pharmacokinetic behavior of another cyp@a substrate , as determined by the enzyme 's constitutive activity ." ]

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

[ "to assess the change in the intermittent and constant osteoarthritis pain ( icoap ) - scale scores in patients taking duloxetine or placebo and to characterize the responsiveness of the icoap by comparing the effect size associated with its scales to effect sizes seen with other pain scales used in this study .", "this was a secondary analysis of data from a @-week , double-blind , randomized , flexible-dose , placebo-controlled trial that enrolled patients who had persistent moderate pain due to osteoarthritis ( oa ) of the knee , despite having received nonsteroidal anti-inflammatory drug ( nsaid ) therapy .", "the pain measures used in this study ( focusing on the drug-placebo difference at week @ ) were patient-rated pain severity , the western ontario and mcmaster universities osteoarthritis index ( womac ) , the brief pain inventory ( bpi ) , and the icoap .", "the mean difference between duloxetine and placebo at week @ for patient-rated pain severity , the bpi average pain , womac pain , and each icoap scale was statistically significant ( p < @ for each ) .", "the icoap total showed a moderate effect size of @ , whereas the constant and intermittent scores showed effect sizes of @ and @ , respectively .", "the patient-rated pain severity and the bpi average pain showed similar moderate effect sizes of @ and @ , respectively .", "the study demonstrated efficacy of duloxetine compared with placebo when using the icoap scale in a placebo-controlled trial .", "the observed treatment effect size for the icoap scores was similar to that for other reliable , valid and responsive pain assessments .", "clinicaltrial.gov identifier : nct@ ." ]

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

[ "cognitive remediation is an intervention to overcome cognitive deficits through drills and use of strategies .", "previous studies have reported positive effects for cognitive remediation on neurocognition , but researchers ' allegiance effects are not always adequately controlled .", "furthermore , its efficacy amongst the asian population has not been established .", "hence , this study aimed to determine if cognitive remediation would have positive effects on neurocognition and functioning within an english-speaking asian population , when compared against the effects of a credible and balanced control provided by therapists blinded to the study hypothesis .", "a total of @ participants with schizophrenia who attended vocational training or day rehabilitation programmes were randomised to receive a @-hour programme of either cognitive remediation or physical exercise .", "neurocognition and functional outcomes were measured at baseline , upon completion of treatment , @ months after treatment and @ year after treatment .", "participants who received cognitive remediation had significantly greater improvement in all neurocognitive domains .", "furthermore , the cognitive remediation group achieved greater attainment of vocational or independent living skills and better functional outcomes at post-intervention and at the end of the @-year follow-up .", "when compared against a credible intervention such as physical exercise , cognitive remediation was able to show significant positive effects on both neurocognition and functional outcomes among the asian population of schizophrenia patients ." ]