text
sequence
text_combined
stringlengths
626
5.36k
pubmed_id
int64
24.2M
26.5M
target
sequence
[ "two percent chlorhexidine gluconate ( chg ) is used in preparing the skin of surgical patients .", "in practice , it often is diluted with saline prior to use .", "whether this affects efficacy is unknown , as the manufacturer does not address dilution but does recommend scrubbing twice .", "we attempted to determine whether diluting chg affects its antiseptic potency and if one scrub is as effective as two .", "to test effects of chg dilution , @ healthy subjects were recruited and randomized into a dilution group ( @ % , @ % , @ % , @ % , or @ % chg ) or a control group ( saline ) .", "one area of one foot of each subject was prepared , and colony-forming units ( cfu ) were counted at baseline and at @min after preparation .", "in a second study , @ subjects were again recruited .", "based on the previous study , a @ % dilution was applied as the scrub .", "colony-forming units were calculated at baseline and after each chg application .", "baseline cfu did not differ among the dilution groups ( p = @ ) .", "subjects in all dilution groups exhibited nearly a @ % decrease in cfu , whereas the control group exhibited an @ % decrease .", "these results were statistically significant ( p < @ ) .", "in the second study , the cfu values after two scrubs ( mean @ ; range @-@ ) were significantly lower than after one scrub ( mean @ , range @-@ ) ( p = @ ) .", "diluting chg to a concentration as low as @ % does not affect antiseptic efficacy .", "the manufacturer-recommended two scrubs is superior to one scrub at reducing skin bacterial colony counts ." ]
two percent chlorhexidine gluconate ( chg ) is used in preparing the skin of surgical patients . in practice , it often is diluted with saline prior to use . whether this affects efficacy is unknown , as the manufacturer does not address dilution but does recommend scrubbing twice . we attempted to determine whether diluting chg affects its antiseptic potency and if one scrub is as effective as two . to test effects of chg dilution , @ healthy subjects were recruited and randomized into a dilution group ( @ % , @ % , @ % , @ % , or @ % chg ) or a control group ( saline ) . one area of one foot of each subject was prepared , and colony-forming units ( cfu ) were counted at baseline and at @min after preparation . in a second study , @ subjects were again recruited . based on the previous study , a @ % dilution was applied as the scrub . colony-forming units were calculated at baseline and after each chg application . baseline cfu did not differ among the dilution groups ( p = @ ) . subjects in all dilution groups exhibited nearly a @ % decrease in cfu , whereas the control group exhibited an @ % decrease . these results were statistically significant ( p < @ ) . in the second study , the cfu values after two scrubs ( mean @ ; range @-@ ) were significantly lower than after one scrub ( mean @ , range @-@ ) ( p = @ ) . diluting chg to a concentration as low as @ % does not affect antiseptic efficacy . the manufacturer-recommended two scrubs is superior to one scrub at reducing skin bacterial colony counts .
24,850,433
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "although uncomplicated cystitis is often self-limiting , most such patients will be prescribed antibiotic treatment .", "we are investigating whether treatment of cystitis with an nsaid is as effective as an antibiotic in achieving symptomatic resolution .", "this is a randomized , controlled , double blind trial following the principles of good clinical practice .", "women between the ages of @ to @ presenting with symptoms of uncomplicated cystitis are screened for eligibility .", "@ women from four sites in norway , sweden and denmark are allocated to treatment with @ mg ibuprofen three times a day or @ mg mecillinam three times a day for three days .", "allocation is conducted using block randomization .", "the primary outcome is the number of patients who feel cured by day four as recorded in a diary .", "adverse events will be handled and reported in accordance with good clinical practice .", "if treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief , we can potentially reduce the use of antibiotics on a global scale .", "eudractnr : @-@-@ .", "clinicaltrials.gov : nct@ ." ]
although uncomplicated cystitis is often self-limiting , most such patients will be prescribed antibiotic treatment . we are investigating whether treatment of cystitis with an nsaid is as effective as an antibiotic in achieving symptomatic resolution . this is a randomized , controlled , double blind trial following the principles of good clinical practice . women between the ages of @ to @ presenting with symptoms of uncomplicated cystitis are screened for eligibility . @ women from four sites in norway , sweden and denmark are allocated to treatment with @ mg ibuprofen three times a day or @ mg mecillinam three times a day for three days . allocation is conducted using block randomization . the primary outcome is the number of patients who feel cured by day four as recorded in a diary . adverse events will be handled and reported in accordance with good clinical practice . if treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief , we can potentially reduce the use of antibiotics on a global scale . eudractnr : @-@-@ . clinicaltrials.gov : nct@ .
25,516,016
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "intravenous loop diuretics are a cornerstone of therapy in acutely decompensated heart failure ( adhf ) .", "we sought to determine if there are any differences in clinical outcomes between intravenous bolus and continuous infusion of loop diuretics .", "subjects with adhf within @ hours of hospital admission were randomly assigned to continuous infusion or twice daily bolus therapy with furosemide .", "there were three co-primary endpoints assessed from admission to discharge : the mean paired changes in serum creatinine , estimated glomerular filtration rate ( egfr ) , and reduction in b-type natriuretic peptide ( bnp ) .", "secondary endpoints included the rate of acute kidney injury ( aki ) , change in body weight and six months follow-up evaluation after discharge .", "a total of @ received a continuous infusion and @ were assigned to bolus treatment .", "at discharge , the mean change in serum creatinine was higher ( +@ @ versus -@ @ mg/dl p < @ ) , and egfr was lower ( -@ @ versus +@ @ ml/min/@ @ m ( @ ) p < @ ) in the continuous arm .", "there was no significant difference in the degree of weight loss ( -@ @ versus -@ @ kg p = @ ) .", "the continuous infusion arm had a greater reduction in bnp over the hospital course , ( -@ @ versus -@ @ pg/ml p = @ ) .", "the rates of aki were comparable ( @ % and @ % p = @ ) between the two groups .", "there was more frequent use of hypertonic saline solutions for hyponatremia ( @ % versus @ % p < @ ) , intravenous dopamine infusions ( @ % versus @ % p = @ ) , and the hospital length of stay was longer in the continuous infusion group ( @ @ versus @ @ days , p < @ ) .", "at @ months there were higher rates of re-admission or death in the continuous infusion group , @ % versus @ % , ( p = @ ) and this mode of treatment independently associated with this outcome after adjusting for baseline and intermediate variables ( adjusted hazard ratio = @ , @ % confidence interval , @ to @ p = @ ) .", "in the setting of adhf , continuous infusion of loop diuretics resulted in greater reductions in bnp from admission to discharge .", "however , this appeared to occur at the consequence of worsened renal filtration function , use of additional treatment , and higher rates of rehospitalization or death at six months .", "clinicaltrials.gov nct@ .", "registered @ september @ ." ]
intravenous loop diuretics are a cornerstone of therapy in acutely decompensated heart failure ( adhf ) . we sought to determine if there are any differences in clinical outcomes between intravenous bolus and continuous infusion of loop diuretics . subjects with adhf within @ hours of hospital admission were randomly assigned to continuous infusion or twice daily bolus therapy with furosemide . there were three co-primary endpoints assessed from admission to discharge : the mean paired changes in serum creatinine , estimated glomerular filtration rate ( egfr ) , and reduction in b-type natriuretic peptide ( bnp ) . secondary endpoints included the rate of acute kidney injury ( aki ) , change in body weight and six months follow-up evaluation after discharge . a total of @ received a continuous infusion and @ were assigned to bolus treatment . at discharge , the mean change in serum creatinine was higher ( +@ @ versus -@ @ mg/dl p < @ ) , and egfr was lower ( -@ @ versus +@ @ ml/min/@ @ m ( @ ) p < @ ) in the continuous arm . there was no significant difference in the degree of weight loss ( -@ @ versus -@ @ kg p = @ ) . the continuous infusion arm had a greater reduction in bnp over the hospital course , ( -@ @ versus -@ @ pg/ml p = @ ) . the rates of aki were comparable ( @ % and @ % p = @ ) between the two groups . there was more frequent use of hypertonic saline solutions for hyponatremia ( @ % versus @ % p < @ ) , intravenous dopamine infusions ( @ % versus @ % p = @ ) , and the hospital length of stay was longer in the continuous infusion group ( @ @ versus @ @ days , p < @ ) . at @ months there were higher rates of re-admission or death in the continuous infusion group , @ % versus @ % , ( p = @ ) and this mode of treatment independently associated with this outcome after adjusting for baseline and intermediate variables ( adjusted hazard ratio = @ , @ % confidence interval , @ to @ p = @ ) . in the setting of adhf , continuous infusion of loop diuretics resulted in greater reductions in bnp from admission to discharge . however , this appeared to occur at the consequence of worsened renal filtration function , use of additional treatment , and higher rates of rehospitalization or death at six months . clinicaltrials.gov nct@ . registered @ september @ .
24,974,232
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "prolonged exposure ( pe ) therapy for post-traumatic stress disorder ( ptsd ) in military veterans has established efficacy , but is ineffective for a substantial number of patients .", "pe is also associated with high dropout rates .", "we hypothesized that hydrocortisone augmentation would enhance symptom improvement and reduce drop-out rates by diminishing the distressing effects of traumatic memories retrieved during imaginal exposure .", "we also hypothesized that in responders , hydrocortisone augmentation would be more effective in reversing glucocorticoid indices associated with ptsd than placebo augmentation .", "twenty-four veterans were randomized to receive either @ mg oral hydrocortisone or placebo prior to pe sessions @-@ in a double-blind protocol .", "glucocorticoid receptor sensitivity was assessed in cultured peripheral blood mononuclear cells ( pbmc ) using the in vitro lysozyme inhibition test and was determined before and after treatment .", "intent-to-treat analysis was performed using latent growth curve modeling of treatment effects on change in ptsd severity over time .", "veterans who no longer met diagnostic criteria for ptsd at post-treatment were designated as responders .", "veterans randomized to hydrocortisone or placebo augmentation did not differ significantly in clinical severity or glucocorticoid sensitivity at pre-treatment .", "hydrocortisone augmentation was associated with greater reduction in total ptsd symptoms compared to placebo , a finding that was explained by significantly greater patient retention in the hydrocortisone augmentation condition .", "a significant treatment condition by responder status interaction for glucocorticoid sensitivity indicated that responders to hydrocortisone augmentation had the highest pre-treatment glucocorticoid sensitivity ( lowest lysozyme ic@-dex ) that diminished over the course of treatment .", "there was a significant association between decline in glucocorticoid responsiveness and improvement in ptsd symptoms among hydrocortisone recipients .", "the results of this pilot study suggest that hydrocortisone augmentation of pe may result in greater retention in treatment and thereby promote ptsd symptom improvement .", "further , the results suggest that particularly elevated glucocorticoid responsiveness at pre-treatment may identify veterans likely to respond to pe combined with an intervention that targets glucocorticoid sensitivity .", "confirmation of these findings will suggest that pharmacologic interventions that target ptsd-associated glucocorticoid dysregulation may be particularly helpful in promoting a positive clinical response to ptsd psychotherapy ." ]
prolonged exposure ( pe ) therapy for post-traumatic stress disorder ( ptsd ) in military veterans has established efficacy , but is ineffective for a substantial number of patients . pe is also associated with high dropout rates . we hypothesized that hydrocortisone augmentation would enhance symptom improvement and reduce drop-out rates by diminishing the distressing effects of traumatic memories retrieved during imaginal exposure . we also hypothesized that in responders , hydrocortisone augmentation would be more effective in reversing glucocorticoid indices associated with ptsd than placebo augmentation . twenty-four veterans were randomized to receive either @ mg oral hydrocortisone or placebo prior to pe sessions @-@ in a double-blind protocol . glucocorticoid receptor sensitivity was assessed in cultured peripheral blood mononuclear cells ( pbmc ) using the in vitro lysozyme inhibition test and was determined before and after treatment . intent-to-treat analysis was performed using latent growth curve modeling of treatment effects on change in ptsd severity over time . veterans who no longer met diagnostic criteria for ptsd at post-treatment were designated as responders . veterans randomized to hydrocortisone or placebo augmentation did not differ significantly in clinical severity or glucocorticoid sensitivity at pre-treatment . hydrocortisone augmentation was associated with greater reduction in total ptsd symptoms compared to placebo , a finding that was explained by significantly greater patient retention in the hydrocortisone augmentation condition . a significant treatment condition by responder status interaction for glucocorticoid sensitivity indicated that responders to hydrocortisone augmentation had the highest pre-treatment glucocorticoid sensitivity ( lowest lysozyme ic@-dex ) that diminished over the course of treatment . there was a significant association between decline in glucocorticoid responsiveness and improvement in ptsd symptoms among hydrocortisone recipients . the results of this pilot study suggest that hydrocortisone augmentation of pe may result in greater retention in treatment and thereby promote ptsd symptom improvement . further , the results suggest that particularly elevated glucocorticoid responsiveness at pre-treatment may identify veterans likely to respond to pe combined with an intervention that targets glucocorticoid sensitivity . confirmation of these findings will suggest that pharmacologic interventions that target ptsd-associated glucocorticoid dysregulation may be particularly helpful in promoting a positive clinical response to ptsd psychotherapy .
25,212,409
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "hypertension develops early in patients with autosomal dominant polycystic kidney disease ( adpkd ) and is associated with disease progression .", "the renin-angiotensin-aldosterone system ( raas ) is implicated in the pathogenesis of hypertension in patients with adpkd .", "dual blockade of the raas may circumvent compensatory mechanisms that limit the efficacy of monotherapy with an angiotensin-converting-enzyme ( ace ) inhibitor or angiotensin ii-receptor blocker ( arb ) .", "in this double-blind , placebo-controlled trial , we randomly assigned @ patients , @ to @ years of age , with adpkd ( estimated glomerular filtration rate -lsb- gfr -rsb- , @ to @ ml per minute per @ m ( @ ) of body-surface area ) to receive an ace inhibitor ( lisinopril ) and placebo or lisinopril and an arb ( telmisartan ) , with the doses adjusted to achieve a blood pressure of @/@ to @/@ mm hg .", "the composite primary outcome was the time to death , end-stage renal disease , or a @ % reduction from the baseline estimated gfr .", "secondary outcomes included the rates of change in urinary aldosterone and albumin excretion , frequency of hospitalizations for any cause and for cardiovascular causes , incidence of pain , frequency of adpkd-related symptoms , quality of life , and adverse study-medication effects .", "patients were followed for @ to @ years .", "there was no significant difference between the study groups in the incidence of the composite primary outcome ( hazard ratio with lisinopril-telmisartan , @ ; @ % confidence interval , @ to @ ) .", "the two treatments controlled blood pressure and lowered urinary aldosterone excretion similarly .", "the rates of decline in the estimated gfr , urinary albumin excretion , and other secondary outcomes and adverse events , including hyperkalemia and acute kidney injury , were also similar in the two groups .", "monotherapy with an ace inhibitor was associated with blood-pressure control in most patients with adpkd and stage @ chronic kidney disease .", "the addition of an arb did not alter the decline in the estimated gfr .", "( funded by the national institute of diabetes and digestive and kidney diseases and others ; halt-pkd -lsb- study b -rsb- clinicaltrials.gov number , nct@ . )" ]
hypertension develops early in patients with autosomal dominant polycystic kidney disease ( adpkd ) and is associated with disease progression . the renin-angiotensin-aldosterone system ( raas ) is implicated in the pathogenesis of hypertension in patients with adpkd . dual blockade of the raas may circumvent compensatory mechanisms that limit the efficacy of monotherapy with an angiotensin-converting-enzyme ( ace ) inhibitor or angiotensin ii-receptor blocker ( arb ) . in this double-blind , placebo-controlled trial , we randomly assigned @ patients , @ to @ years of age , with adpkd ( estimated glomerular filtration rate -lsb- gfr -rsb- , @ to @ ml per minute per @ m ( @ ) of body-surface area ) to receive an ace inhibitor ( lisinopril ) and placebo or lisinopril and an arb ( telmisartan ) , with the doses adjusted to achieve a blood pressure of @/@ to @/@ mm hg . the composite primary outcome was the time to death , end-stage renal disease , or a @ % reduction from the baseline estimated gfr . secondary outcomes included the rates of change in urinary aldosterone and albumin excretion , frequency of hospitalizations for any cause and for cardiovascular causes , incidence of pain , frequency of adpkd-related symptoms , quality of life , and adverse study-medication effects . patients were followed for @ to @ years . there was no significant difference between the study groups in the incidence of the composite primary outcome ( hazard ratio with lisinopril-telmisartan , @ ; @ % confidence interval , @ to @ ) . the two treatments controlled blood pressure and lowered urinary aldosterone excretion similarly . the rates of decline in the estimated gfr , urinary albumin excretion , and other secondary outcomes and adverse events , including hyperkalemia and acute kidney injury , were also similar in the two groups . monotherapy with an ace inhibitor was associated with blood-pressure control in most patients with adpkd and stage @ chronic kidney disease . the addition of an arb did not alter the decline in the estimated gfr . ( funded by the national institute of diabetes and digestive and kidney diseases and others ; halt-pkd -lsb- study b -rsb- clinicaltrials.gov number , nct@ . )
25,399,731
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "surgical extraction of lower third molars is followed by mild or severe postoperative pain which peaks at maximal intensity in the first @ hours and has a significant impact on a patient 's postoperative quality of life .", "the use of long-acting local anaesthetics is a promising strategy to improve postoperative analgesia .", "the aim of the present study was to investigate analgesic parameters and patient satisfaction after using @ % levobupivacaine ( lbup ) , @ % bupivacaine ( bup ) and @ % lidocaine with epinephrine @:@,@ ( lid + epi ) for an inferior alveolar nerve block following lower third molar surgery .", "a total of @ patients ( asa i ) were divided into three groups , each of which received either @ ml of lbup , bup or lid + epi .", "the intensity of postoperative analgesia was measured using a verbal rating scale ( vrs ) .", "the total amounts of rescue analgesics were recorded on the first and during seven postoperative days .", "patients satisfaction was noted using a modified verbal scales .", "a significantly higher level of postoperative pain was recorded in lid + epi group compared to bup and lbup groups .", "no significant differences were seen between bup and lbup , but a significant reduction in the need for rescue analgesics was seen postoperatively in both lbup and bup ( @ % ) in comparison with lid + epi ( @ % ) in the first @ hours .", "the same significant trend in rescue analgesic consumption was recorded for seven postoperative days .", "patients ' overall satisfaction was significantly lower for lid + epi ( @ % ) than for lbup ( @ % ) and bup ( @ % ) .", "the use of a new and long-acting local anaesthetic @ % levobupivacaine is clinically relevant and effective for an inferior alveolar nerve block and postoperative pain control after third molar surgery .", "in our study lbup and bup controled postoperative pain more efficiently after lower third molar surgery compared to lid + epi ." ]
surgical extraction of lower third molars is followed by mild or severe postoperative pain which peaks at maximal intensity in the first @ hours and has a significant impact on a patient 's postoperative quality of life . the use of long-acting local anaesthetics is a promising strategy to improve postoperative analgesia . the aim of the present study was to investigate analgesic parameters and patient satisfaction after using @ % levobupivacaine ( lbup ) , @ % bupivacaine ( bup ) and @ % lidocaine with epinephrine @:@,@ ( lid + epi ) for an inferior alveolar nerve block following lower third molar surgery . a total of @ patients ( asa i ) were divided into three groups , each of which received either @ ml of lbup , bup or lid + epi . the intensity of postoperative analgesia was measured using a verbal rating scale ( vrs ) . the total amounts of rescue analgesics were recorded on the first and during seven postoperative days . patients satisfaction was noted using a modified verbal scales . a significantly higher level of postoperative pain was recorded in lid + epi group compared to bup and lbup groups . no significant differences were seen between bup and lbup , but a significant reduction in the need for rescue analgesics was seen postoperatively in both lbup and bup ( @ % ) in comparison with lid + epi ( @ % ) in the first @ hours . the same significant trend in rescue analgesic consumption was recorded for seven postoperative days . patients ' overall satisfaction was significantly lower for lid + epi ( @ % ) than for lbup ( @ % ) and bup ( @ % ) . the use of a new and long-acting local anaesthetic @ % levobupivacaine is clinically relevant and effective for an inferior alveolar nerve block and postoperative pain control after third molar surgery . in our study lbup and bup controled postoperative pain more efficiently after lower third molar surgery compared to lid + epi .
26,043,591
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "awake fiberoptic intubation is the gold standard for management of predicted difficult intubation .", "the purpose of this study was to test whether glide scope video laryngoscopy ( gvl ) will provide significant advantages over fiberoptic bronchoscopy ( fob ) for awake intubation in morbidly obese patients with predicted difficult intubation .", "we therefore tested the hypothesis that intubation using gvl is faster than intubation with fob .", "@ morbidly obese patients with predicted difficult intubation undergoing laparoscopic bariatric surgery were enrolled in this study .", "patients were randomly assigned to receive awake oral intubation by either gvl or fob .", "after airway topical anesthesia and sedation using target controlled remifentanil infusion to a ramsay sedation scale of @ , wee compared the two devices for time to intubate , successful intubation on first attempt , glottic view using cormack and lehane score system , response of the patient to scope , patients satisfaction and incidence of postoperative sore throat and hoarseness .", "intubation time was @ + / - @ seconds and @ + / - @ seconds for fob and gvl respectively .", "@ % of patients were successfully intubated on the first attempt with fob compared to @ % with gvl .", "grade i/ii glottic view was reported with gvl in @ % of patients compared to @ % with fob .", "the highest target concentration of remifentanil to maintain patients sedated during intubation was @ + / - @ ng/ml and @ + / - @ ng/ml in fob and gvl respectively .", "no significant differences regarding maximum patient response to intubation , adverse effects or patient satisfaction were recorded between groups .", "gvl can be used as a useful alternative to fob in morbidly obese patients with predicted difficult intubation ." ]
awake fiberoptic intubation is the gold standard for management of predicted difficult intubation . the purpose of this study was to test whether glide scope video laryngoscopy ( gvl ) will provide significant advantages over fiberoptic bronchoscopy ( fob ) for awake intubation in morbidly obese patients with predicted difficult intubation . we therefore tested the hypothesis that intubation using gvl is faster than intubation with fob . @ morbidly obese patients with predicted difficult intubation undergoing laparoscopic bariatric surgery were enrolled in this study . patients were randomly assigned to receive awake oral intubation by either gvl or fob . after airway topical anesthesia and sedation using target controlled remifentanil infusion to a ramsay sedation scale of @ , wee compared the two devices for time to intubate , successful intubation on first attempt , glottic view using cormack and lehane score system , response of the patient to scope , patients satisfaction and incidence of postoperative sore throat and hoarseness . intubation time was @ + / - @ seconds and @ + / - @ seconds for fob and gvl respectively . @ % of patients were successfully intubated on the first attempt with fob compared to @ % with gvl . grade i/ii glottic view was reported with gvl in @ % of patients compared to @ % with fob . the highest target concentration of remifentanil to maintain patients sedated during intubation was @ + / - @ ng/ml and @ + / - @ ng/ml in fob and gvl respectively . no significant differences regarding maximum patient response to intubation , adverse effects or patient satisfaction were recorded between groups . gvl can be used as a useful alternative to fob in morbidly obese patients with predicted difficult intubation .
25,007,692
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "bevacizumab , a recombinant humanized monoclonal antibody against vascular endothelial growth factor , was approved by the us food and drug administration for the treatment of advanced non-small-cell lung cancer ( nsclc ) in combination with carboplatin and paclitaxel .", "aries ( avastin regimens : investigation of effectiveness and safety ) , a prospective observational cohort study , evaluated outcomes in a large , community-based population of patients with first-line nsclc .", "from @ to @ , aries enrolled patients with locally advanced or metastatic nsclc who were eligible for bevacizumab , excluding those with predominantly squamous histology .", "patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within @ months before enrollment .", "there were no protocol-defined treatments or assessments .", "the dosing of bevacizumab and chemotherapy , and the choice of chemotherapy regimen , was at the discretion of the treating physician .", "aries enrolled @ patients with first-line nsclc .", "at study closure , median follow-up was @ months ( range , @-@ @ ) .", "median age was @ years ( range , @-@ ) , and @ patients ( @ % ) identified as never smokers .", "median progression-free survival was @ months ( @ % confidence interval , @-@ @ ) , and median overall survival was @ months ( @ % confidence interval , @-@ @ ) with first-line bevacizumab plus chemotherapy .", "incidences of bevacizumab-associated adverse events ( @ % overall ) were consistent with those in randomized controlled trials of bevacizumab in nsclc .", "results from aries demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced nsclc ." ]
bevacizumab , a recombinant humanized monoclonal antibody against vascular endothelial growth factor , was approved by the us food and drug administration for the treatment of advanced non-small-cell lung cancer ( nsclc ) in combination with carboplatin and paclitaxel . aries ( avastin regimens : investigation of effectiveness and safety ) , a prospective observational cohort study , evaluated outcomes in a large , community-based population of patients with first-line nsclc . from @ to @ , aries enrolled patients with locally advanced or metastatic nsclc who were eligible for bevacizumab , excluding those with predominantly squamous histology . patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within @ months before enrollment . there were no protocol-defined treatments or assessments . the dosing of bevacizumab and chemotherapy , and the choice of chemotherapy regimen , was at the discretion of the treating physician . aries enrolled @ patients with first-line nsclc . at study closure , median follow-up was @ months ( range , @-@ @ ) . median age was @ years ( range , @-@ ) , and @ patients ( @ % ) identified as never smokers . median progression-free survival was @ months ( @ % confidence interval , @-@ @ ) , and median overall survival was @ months ( @ % confidence interval , @-@ @ ) with first-line bevacizumab plus chemotherapy . incidences of bevacizumab-associated adverse events ( @ % overall ) were consistent with those in randomized controlled trials of bevacizumab in nsclc . results from aries demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced nsclc .
25,122,429
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate effects of maropitant , acepromazine , and electroacupuncture on morphine-related signs of nausea and vomiting in dogs and assess sedative effects of the treatments .", "randomized controlled clinical trial .", "@ dogs .", "dogs received @ of @ treatments : injection of saline ( @ % nacl ) solution , maropitant citrate , or acepromazine maleate or electroacupuncture treatment at @ acupoint , @ acupoints , or a sham acupoint .", "morphine was administered after @ minutes of electroacupuncture treatment or @ minutes after injectable treatment .", "vomiting and retching events and signs of nausea and sedation were recorded .", "incidence of vomiting and retching was significantly lower in the maropitant ( @/@ -lsb- @ % -rsb- ) group than in the saline solution ( @/@ -lsb- @ % -rsb- ) and sham-acupoint electroacupuncture ( @/@ -lsb- @ % -rsb- ) groups .", "the number of vomiting and retching events in the maropitant ( @ ) , acepromazine ( @ ) , @-acupoint ( @ ) , and @-acupoint ( @ ) groups was significantly lower than in the saline solution ( @ ) and sham-acupoint electroacupuncture ( @ ) groups .", "incidence of signs of nausea was significantly lower in the acepromazine group ( @/@ -lsb- @ % -rsb- ) than in the sham-acupoint group ( @/@ -lsb- @ % -rsb- ) .", "mean nausea scores for the saline solution , maropitant , and sham-acupoint electroacupuncture groups increased significantly after morphine administration , whereas those for the acepromazine , @-acupoint electroacupuncture , and @-acupoint electroacupuncture groups did not .", "mean sedation scores after morphine administration were significantly higher in dogs that received acepromazine than in dogs that received saline solution , maropitant , and sham-acupoint electroacupuncture treatment .", "maropitant treatment was associated with a lower incidence of vomiting and retching , compared with control treatments , and acepromazine and electroacupuncture appeared to prevent an increase in severity of nausea following morphine administration in dogs ." ]
to evaluate effects of maropitant , acepromazine , and electroacupuncture on morphine-related signs of nausea and vomiting in dogs and assess sedative effects of the treatments . randomized controlled clinical trial . @ dogs . dogs received @ of @ treatments : injection of saline ( @ % nacl ) solution , maropitant citrate , or acepromazine maleate or electroacupuncture treatment at @ acupoint , @ acupoints , or a sham acupoint . morphine was administered after @ minutes of electroacupuncture treatment or @ minutes after injectable treatment . vomiting and retching events and signs of nausea and sedation were recorded . incidence of vomiting and retching was significantly lower in the maropitant ( @/@ -lsb- @ % -rsb- ) group than in the saline solution ( @/@ -lsb- @ % -rsb- ) and sham-acupoint electroacupuncture ( @/@ -lsb- @ % -rsb- ) groups . the number of vomiting and retching events in the maropitant ( @ ) , acepromazine ( @ ) , @-acupoint ( @ ) , and @-acupoint ( @ ) groups was significantly lower than in the saline solution ( @ ) and sham-acupoint electroacupuncture ( @ ) groups . incidence of signs of nausea was significantly lower in the acepromazine group ( @/@ -lsb- @ % -rsb- ) than in the sham-acupoint group ( @/@ -lsb- @ % -rsb- ) . mean nausea scores for the saline solution , maropitant , and sham-acupoint electroacupuncture groups increased significantly after morphine administration , whereas those for the acepromazine , @-acupoint electroacupuncture , and @-acupoint electroacupuncture groups did not . mean sedation scores after morphine administration were significantly higher in dogs that received acepromazine than in dogs that received saline solution , maropitant , and sham-acupoint electroacupuncture treatment . maropitant treatment was associated with a lower incidence of vomiting and retching , compared with control treatments , and acepromazine and electroacupuncture appeared to prevent an increase in severity of nausea following morphine administration in dogs .
24,649,993
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "over-diagnosis of malaria among african children results in mismanagement of non-malaria infections .", "limited laboratory capacity makes it difficult to implement policies that recommend pre-treatment confirmation of infections so a new approach with a package for on-the-spot management of fevers was evaluated .", "febrile children presenting to outpatient clinic were randomized to receive either a ` test-treat ' package ( history with clinical examination ; point-of-care tests ; choice of artesunate-amodiaquine , co-amoxiclav and/or paracetamol ) or routine outpatient care in a secondary health care facility in kumasi , ghana .", "a diagnosis of malaria , bacterial , viral or mixed malarial and bacterial infections was made using pre-defined criteria .", "outcome was resolution of all symptoms including fever on day @ .", "the median age of the patients was @ months ( iqr : @ to @ months ) , with @ % being males .", "compared to routine care the test-treat package resulted in less diagnoses of malaria , ( @ % vs @ % , p = @ ) and mixed malaria and bacterial infections ( @ % vs @ % , p < @ ) but more diagnoses of viral ( @ % vs @ % , p < @ ) and bacterial infections only ( @ % vs @ % , p < @ ) .", "less anti-malarials ( @ % vs @ % , p < @ ) and antibiotics ( @ % vs @ % , p < @ ) , were prescribed in the test-treat group on completion of study , more test-treat package patients were clinically well ( @ % vs @ % , p < @ ) and febrile ( @ % vs @ % , p = @ ) and less were admitted for inpatient care ( @ % vs @ % p = @ ) compared to the routine care group .", "test-treat package improves the effectiveness of outpatient diagnosis and treatment of children with fever and reduces inappropriate prescribing of anti-malarials and antibiotics .", "the package provides clinicians with the option for immediate diagnosis and treatment of non-malaria fevers .", "the test-treat package now needs to be evaluated in other settings including primary health care facilities ." ]
over-diagnosis of malaria among african children results in mismanagement of non-malaria infections . limited laboratory capacity makes it difficult to implement policies that recommend pre-treatment confirmation of infections so a new approach with a package for on-the-spot management of fevers was evaluated . febrile children presenting to outpatient clinic were randomized to receive either a ` test-treat ' package ( history with clinical examination ; point-of-care tests ; choice of artesunate-amodiaquine , co-amoxiclav and/or paracetamol ) or routine outpatient care in a secondary health care facility in kumasi , ghana . a diagnosis of malaria , bacterial , viral or mixed malarial and bacterial infections was made using pre-defined criteria . outcome was resolution of all symptoms including fever on day @ . the median age of the patients was @ months ( iqr : @ to @ months ) , with @ % being males . compared to routine care the test-treat package resulted in less diagnoses of malaria , ( @ % vs @ % , p = @ ) and mixed malaria and bacterial infections ( @ % vs @ % , p < @ ) but more diagnoses of viral ( @ % vs @ % , p < @ ) and bacterial infections only ( @ % vs @ % , p < @ ) . less anti-malarials ( @ % vs @ % , p < @ ) and antibiotics ( @ % vs @ % , p < @ ) , were prescribed in the test-treat group on completion of study , more test-treat package patients were clinically well ( @ % vs @ % , p < @ ) and febrile ( @ % vs @ % , p = @ ) and less were admitted for inpatient care ( @ % vs @ % p = @ ) compared to the routine care group . test-treat package improves the effectiveness of outpatient diagnosis and treatment of children with fever and reduces inappropriate prescribing of anti-malarials and antibiotics . the package provides clinicians with the option for immediate diagnosis and treatment of non-malaria fevers . the test-treat package now needs to be evaluated in other settings including primary health care facilities .
25,428,264
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the @ american college of cardiologists/american heart association guidelines on perioperative cardiac evaluation and care for noncardiac surgery is the standard for perioperative cardiac evaluation .", "recent work has shown that residents and anesthesiologists do not apply these guidelines when tested .", "this research hypothesized that a decision support tool would improve adherence to this consensus guideline .", "anesthesiology residents at four training programs participated in an unblinded , prospective , randomized , cross-over trial in which they completed two tests covering clinical scenarios .", "one quiz was completed from memory and one with the aid of an electronic decision support tool .", "performance was evaluated by overall score ( % correct ) , number of incorrect answers with possibly increased cost or risk of care , and the amount of time required to complete the quizzes both with and without the cognitive aid .", "the primary outcome was the proportion of correct responses attributable to the use of the decision support tool .", "all anesthesiology residents at four institutions were recruited and @ residents participated .", "use of the decision support tool resulted in a @ % improvement in adherence to guidelines compared with memory alone ( p < @ ) , and participants made @ % fewer incorrect responses that would have resulted in increased costs .", "use of the tool was associated with a @-min increase in time to complete the test ( p < @ ) .", "use of an electronic decision support tool significantly improved adherence to the guidelines as compared with memory alone .", "the decision support tool also prevented inappropriate management steps possibly associated with increased healthcare costs ." ]
the @ american college of cardiologists/american heart association guidelines on perioperative cardiac evaluation and care for noncardiac surgery is the standard for perioperative cardiac evaluation . recent work has shown that residents and anesthesiologists do not apply these guidelines when tested . this research hypothesized that a decision support tool would improve adherence to this consensus guideline . anesthesiology residents at four training programs participated in an unblinded , prospective , randomized , cross-over trial in which they completed two tests covering clinical scenarios . one quiz was completed from memory and one with the aid of an electronic decision support tool . performance was evaluated by overall score ( % correct ) , number of incorrect answers with possibly increased cost or risk of care , and the amount of time required to complete the quizzes both with and without the cognitive aid . the primary outcome was the proportion of correct responses attributable to the use of the decision support tool . all anesthesiology residents at four institutions were recruited and @ residents participated . use of the decision support tool resulted in a @ % improvement in adherence to guidelines compared with memory alone ( p < @ ) , and participants made @ % fewer incorrect responses that would have resulted in increased costs . use of the tool was associated with a @-min increase in time to complete the test ( p < @ ) . use of an electronic decision support tool significantly improved adherence to the guidelines as compared with memory alone . the decision support tool also prevented inappropriate management steps possibly associated with increased healthcare costs .
24,705,442
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to examine the relationships between stressful life events and physiological measures , adherence to prescribed oral medication regimens , depressive symptoms , and impaired quality of life ( qol ) in adolescents with recent-onset type @ diabetes ( t@d ) .", "data were collected from @ ethnically diverse participants ( @ % female ) in the final year of the treatment options for type @ diabetes in adolescents and youth multicenter clinical trial .", "exposure to @ possible events over the previous year and rating of subsequent distress were collected by self-report and summarized as a major stressors score .", "this score was analyzed for relationship to glycemic control ( hemoglobin a@c and treatment failure ) , body mass index , diagnosis of hypertension or triglyceride dyslipidemia , adherence to a prescribed oral medication regimen , presence of depressive symptoms , and impaired qol .", "the total number of major stressful life events in the adolescents with t@d was calculated , with @ % reporting none , @ % reporting @ , @ % reporting @ , @ % reporting @ , and @ % reporting @ .", "there were no associations between the major stressors score and physiological measures or diagnosis of comorbidities .", "the odds of medication nonadherence increased significantly from those reporting @ major stressor ( or , @ ; p = @ ) to those reporting @ major stressors ( or , @ ; p = @ ) .", "significant odds of elevated depressive symptoms and impaired qol were also found with increased reporting of major stressors .", "exposure to major stressful life events is associated with lower adherence to prescribed oral medication regimens and impaired psychosocial functioning in adolescents with t@d ." ]
to examine the relationships between stressful life events and physiological measures , adherence to prescribed oral medication regimens , depressive symptoms , and impaired quality of life ( qol ) in adolescents with recent-onset type @ diabetes ( t@d ) . data were collected from @ ethnically diverse participants ( @ % female ) in the final year of the treatment options for type @ diabetes in adolescents and youth multicenter clinical trial . exposure to @ possible events over the previous year and rating of subsequent distress were collected by self-report and summarized as a major stressors score . this score was analyzed for relationship to glycemic control ( hemoglobin a@c and treatment failure ) , body mass index , diagnosis of hypertension or triglyceride dyslipidemia , adherence to a prescribed oral medication regimen , presence of depressive symptoms , and impaired qol . the total number of major stressful life events in the adolescents with t@d was calculated , with @ % reporting none , @ % reporting @ , @ % reporting @ , @ % reporting @ , and @ % reporting @ . there were no associations between the major stressors score and physiological measures or diagnosis of comorbidities . the odds of medication nonadherence increased significantly from those reporting @ major stressor ( or , @ ; p = @ ) to those reporting @ major stressors ( or , @ ; p = @ ) . significant odds of elevated depressive symptoms and impaired qol were also found with increased reporting of major stressors . exposure to major stressful life events is associated with lower adherence to prescribed oral medication regimens and impaired psychosocial functioning in adolescents with t@d .
24,948,348
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "low back pain ( lbp ) is responsible for more than @ million visits to us emergency departments ( eds ) annually .", "these patients are usually treated with nonsteroidal anti-inflammatory drugs , acetaminophen , opioids , or skeletal muscle relaxants , often in combination .", "to compare functional outcomes and pain at @ week and @ months after an ed visit for acute lbp among patients randomized to a @-day course of ( @ ) naproxen + placebo ; ( @ ) naproxen + cyclobenzaprine ; or ( @ ) naproxen + oxycodone/acetaminophen .", "this randomized , double-blind , @-group study was conducted at one urban ed in the bronx , new york city .", "patients who presented with nontraumatic , nonradicular lbp of @ weeks ' duration or less were eligible for enrollment upon ed discharge if they had a score greater than @ on the roland-morris disability questionnaire ( rmdq ) .", "the rmdq is a @-item questionnaire commonly used to measure lbp and related functional impairment on which @ indicates no functional impairment and @ indicates maximum impairment .", "beginning in april @ , a total of @ patients were approached for enrollment .", "of the @ deemed eligible for participation , @ were randomized to receive placebo and @ each to cyclobenzaprine and to oxycodone/acetaminophen .", "follow-up was completed in december @ .", "all participants were given @ tablets of naproxen , @ mg , to be taken twice a day .", "they were randomized to receive either @ tablets of placebo ; cyclobenzaprine , @ mg ; or oxycodone , @ mg/acetaminophen , @ mg .", "participants were instructed to take @ or @ of these tablets every @ hours , as needed for lbp .", "they also received a standardized @-minute lbp educational session prior to discharge .", "the primary outcome was improvement in rmdq between ed discharge and @ week later .", "demographic characteristics were comparable among the @ groups .", "at baseline , median rmdq score in the placebo group was @ ( interquartile range -lsb- iqr -rsb- ,@ -@ ) , in the cyclobenzaprine group @ ( iqr,@-@ ) , and in the oxycodone/acetaminophen group @ ( iqr,@-@ ) .", "at @-week follow-up , the mean rmdq improvement was @ in the placebo group , @ in the cyclobenzaprine group , and @ in the oxycodone/acetaminophen group .", "between-group difference in mean rmdq improvement for cyclobenzaprine vs placebo was @ ( @ % ci , -@ to @ ; p = @ ) , for oxycodone/acetaminophen vs placebo , @ ( @ % ci , -@ to @ ; p = @ ) , and for oxycodone/acetaminophen vs cyclobenzaprine , @ ( @ % ci , -@ to @ ; p = @ ) .", "among patients with acute , nontraumatic , nonradicular lbp presenting to the ed , adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at @-week follow-up .", "these findings do not support use of these additional medications in this setting .", "clinicaltrials.gov identifier : nct@ ." ]
low back pain ( lbp ) is responsible for more than @ million visits to us emergency departments ( eds ) annually . these patients are usually treated with nonsteroidal anti-inflammatory drugs , acetaminophen , opioids , or skeletal muscle relaxants , often in combination . to compare functional outcomes and pain at @ week and @ months after an ed visit for acute lbp among patients randomized to a @-day course of ( @ ) naproxen + placebo ; ( @ ) naproxen + cyclobenzaprine ; or ( @ ) naproxen + oxycodone/acetaminophen . this randomized , double-blind , @-group study was conducted at one urban ed in the bronx , new york city . patients who presented with nontraumatic , nonradicular lbp of @ weeks ' duration or less were eligible for enrollment upon ed discharge if they had a score greater than @ on the roland-morris disability questionnaire ( rmdq ) . the rmdq is a @-item questionnaire commonly used to measure lbp and related functional impairment on which @ indicates no functional impairment and @ indicates maximum impairment . beginning in april @ , a total of @ patients were approached for enrollment . of the @ deemed eligible for participation , @ were randomized to receive placebo and @ each to cyclobenzaprine and to oxycodone/acetaminophen . follow-up was completed in december @ . all participants were given @ tablets of naproxen , @ mg , to be taken twice a day . they were randomized to receive either @ tablets of placebo ; cyclobenzaprine , @ mg ; or oxycodone , @ mg/acetaminophen , @ mg . participants were instructed to take @ or @ of these tablets every @ hours , as needed for lbp . they also received a standardized @-minute lbp educational session prior to discharge . the primary outcome was improvement in rmdq between ed discharge and @ week later . demographic characteristics were comparable among the @ groups . at baseline , median rmdq score in the placebo group was @ ( interquartile range -lsb- iqr -rsb- ,@ -@ ) , in the cyclobenzaprine group @ ( iqr,@-@ ) , and in the oxycodone/acetaminophen group @ ( iqr,@-@ ) . at @-week follow-up , the mean rmdq improvement was @ in the placebo group , @ in the cyclobenzaprine group , and @ in the oxycodone/acetaminophen group . between-group difference in mean rmdq improvement for cyclobenzaprine vs placebo was @ ( @ % ci , -@ to @ ; p = @ ) , for oxycodone/acetaminophen vs placebo , @ ( @ % ci , -@ to @ ; p = @ ) , and for oxycodone/acetaminophen vs cyclobenzaprine , @ ( @ % ci , -@ to @ ; p = @ ) . among patients with acute , nontraumatic , nonradicular lbp presenting to the ed , adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at @-week follow-up . these findings do not support use of these additional medications in this setting . clinicaltrials.gov identifier : nct@ .
26,501,533
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to improve survival rates in children with acute myeloid leukemia ( aml ) , we evaluated gemtuzumab-ozogamicin ( go ) , a humanized immunoconjugate targeted against cd@ , as an alternative to further chemotherapy dose escalation .", "our primary objective was to determine whether adding go to standard chemotherapy improved event-free survival ( efs ) and overall survival ( os ) in children with newly diagnosed aml .", "our secondary objectives examined outcomes by risk group and method of intensification .", "children , adolescents , and young adults ages @ to @ years with newly diagnosed aml were enrolled onto childrens oncology group trial aaml@ and then were randomly assigned to either standard five-course chemotherapy alone or to the same chemotherapy with two doses of go ( @ mg/m@/dose ) administered once in induction course @ and once in intensification course @ ( two of three ) .", "there were @,@ evaluable patients enrolled .", "go significantly improved efs ( @ years : @ % v. @ % ; hazard ratio -lsb- hzr -rsb- , @ ; @ % ci , @ to @ ; p. @ ) but not os ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) .", "although remission was not improved ( @ % v. @ % ; p = @ ) , posthoc analyses found relapse risk ( rr ) was significantly reduced among go recipients overall ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) .", "despite an increased postremission toxic mortality ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) , disease-free survival was better among go recipients ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) .", "go added to chemotherapy improved efs through a reduction in rr for children and adolescents with aml ." ]
to improve survival rates in children with acute myeloid leukemia ( aml ) , we evaluated gemtuzumab-ozogamicin ( go ) , a humanized immunoconjugate targeted against cd@ , as an alternative to further chemotherapy dose escalation . our primary objective was to determine whether adding go to standard chemotherapy improved event-free survival ( efs ) and overall survival ( os ) in children with newly diagnosed aml . our secondary objectives examined outcomes by risk group and method of intensification . children , adolescents , and young adults ages @ to @ years with newly diagnosed aml were enrolled onto childrens oncology group trial aaml@ and then were randomly assigned to either standard five-course chemotherapy alone or to the same chemotherapy with two doses of go ( @ mg/m@/dose ) administered once in induction course @ and once in intensification course @ ( two of three ) . there were @,@ evaluable patients enrolled . go significantly improved efs ( @ years : @ % v. @ % ; hazard ratio -lsb- hzr -rsb- , @ ; @ % ci , @ to @ ; p. @ ) but not os ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) . although remission was not improved ( @ % v. @ % ; p = @ ) , posthoc analyses found relapse risk ( rr ) was significantly reduced among go recipients overall ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) . despite an increased postremission toxic mortality ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) , disease-free survival was better among go recipients ( @ years : @ % v. @ % ; hzr , @ ; @ % ci , @ to @ ; p = @ ) . go added to chemotherapy improved efs through a reduction in rr for children and adolescents with aml .
25,092,781
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "fatigue is one of many unintended consequences of shift work in the nursing profession .", "natural health products ( nhps ) for fatigue are becoming an increasingly popular topic of clinical study ; one such nhp is rhodiola rosea .", "a well-designed , rigorously conducted randomized controlled trial is required before therapeutic claims for this product can be made .", "to compare the efficacy of r. rosea with placebo for reducing fatigue in nursing students on shift work .", "a parallel-group randomized , double-blinded , placebo-controlled trial of @-@ year old students from the faculty of nursing from the university of alberta , participating in clinical rotations between january @ and september @ .", "participants were randomized to take @ mg of either r. rosea or identical placebo at the start of their wakeful period and up to one additional capsule within the following four hours on a daily basis over a @-day period .", "the primary outcome was reduction in fatigue over the @-day trial period measured using the vitality-subscale of the rand-@ , cross-validated by the visual analogue scale for fatigue ( vas-f ) .", "secondary outcomes included health-related quality of life , individualized outcomes assessment , and adverse events .", "a total of @ participants were randomized to r. rosea ( n = @ ) or placebo ( n = @ ) .", "the mean change in scores on the vitality-subscale was significantly different between the study groups at day @ in favor of placebo ( -@ ( @ % ci -@ , -@ ) , p = @ ) , the mean change in scores on the vas-f was also significantly difference between study groups at day @ in favour of placebo ( @ ( @ % ci @ , @ ) , p = @ ) .", "total number of adverse events did not differ between r. rosea and placebo groups .", "this study indicates that among nursing students on shift work , a @-day course of r. rosea compared with placebo worsened fatigue ; however , the results should be interpreted with caution .", "clinicaltrials.gov nct@ ." ]
fatigue is one of many unintended consequences of shift work in the nursing profession . natural health products ( nhps ) for fatigue are becoming an increasingly popular topic of clinical study ; one such nhp is rhodiola rosea . a well-designed , rigorously conducted randomized controlled trial is required before therapeutic claims for this product can be made . to compare the efficacy of r. rosea with placebo for reducing fatigue in nursing students on shift work . a parallel-group randomized , double-blinded , placebo-controlled trial of @-@ year old students from the faculty of nursing from the university of alberta , participating in clinical rotations between january @ and september @ . participants were randomized to take @ mg of either r. rosea or identical placebo at the start of their wakeful period and up to one additional capsule within the following four hours on a daily basis over a @-day period . the primary outcome was reduction in fatigue over the @-day trial period measured using the vitality-subscale of the rand-@ , cross-validated by the visual analogue scale for fatigue ( vas-f ) . secondary outcomes included health-related quality of life , individualized outcomes assessment , and adverse events . a total of @ participants were randomized to r. rosea ( n = @ ) or placebo ( n = @ ) . the mean change in scores on the vitality-subscale was significantly different between the study groups at day @ in favor of placebo ( -@ ( @ % ci -@ , -@ ) , p = @ ) , the mean change in scores on the vas-f was also significantly difference between study groups at day @ in favour of placebo ( @ ( @ % ci @ , @ ) , p = @ ) . total number of adverse events did not differ between r. rosea and placebo groups . this study indicates that among nursing students on shift work , a @-day course of r. rosea compared with placebo worsened fatigue ; however , the results should be interpreted with caution . clinicaltrials.gov nct@ .
25,268,730
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "stroke is one of the most common causes of cognitive impairment .", "up to @ % of stroke survivors may be considered to have cognitive impairment , which severely limit individual autonomy for successful reintegration into family , work and social life .", "the clinical efficacy of acupuncture with baihui ( du@ ) and shenting ( du@ ) in stroke and post-stroke cognitive impairment has been previously demonstrated .", "computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients .", "however , the cognitive impairment after stroke is so complexity that one single treatment can not resolve effectively .", "besides , the effects of acupuncture and rehacom cognitive training have not been systematically compared , nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated .", "our primary aim of this trial is to evaluate the synergistic effect of acupuncture and rehacom cognitive training on cognitive dysfunction after stroke .", "a randomized controlled trial of @ @ factorial design will be conducted in the rehabilitation hospital affiliated to fujian university of traditional chinese medicine .", "a total of @ patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and randomized into rehacom training group , acupuncture group , a combination of both or control group in a @:@:@:@ ratio .", "all patients will receive conventional treatment .", "the interventions will last for @ weeks ( @ min per day , monday to friday every week ) .", "evaluations will be conducted by blinded assessors at baseline and again at @ , @ and @ weeks .", "outcome measurements include mini-mental state examination ( mmse ) , montreal cognitive assessments ( moca ) , functional independence measure scale ( fim ) and adverse events .", "the results of this trial are expected to clarify the synergistic effect of acupuncture and rehacom cognitive training on cognitive dysfunction after stroke .", "furthermore , to confirm whether combined or alone of acupuncture and rehacom cognitive training , is more effective than conventional treatment in the management of post-stroke cognitive dysfunction .", "chinese clinical trial registry : chictr-trc-@ ." ]
stroke is one of the most common causes of cognitive impairment . up to @ % of stroke survivors may be considered to have cognitive impairment , which severely limit individual autonomy for successful reintegration into family , work and social life . the clinical efficacy of acupuncture with baihui ( du@ ) and shenting ( du@ ) in stroke and post-stroke cognitive impairment has been previously demonstrated . computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients . however , the cognitive impairment after stroke is so complexity that one single treatment can not resolve effectively . besides , the effects of acupuncture and rehacom cognitive training have not been systematically compared , nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated . our primary aim of this trial is to evaluate the synergistic effect of acupuncture and rehacom cognitive training on cognitive dysfunction after stroke . a randomized controlled trial of @ @ factorial design will be conducted in the rehabilitation hospital affiliated to fujian university of traditional chinese medicine . a total of @ patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and randomized into rehacom training group , acupuncture group , a combination of both or control group in a @:@:@:@ ratio . all patients will receive conventional treatment . the interventions will last for @ weeks ( @ min per day , monday to friday every week ) . evaluations will be conducted by blinded assessors at baseline and again at @ , @ and @ weeks . outcome measurements include mini-mental state examination ( mmse ) , montreal cognitive assessments ( moca ) , functional independence measure scale ( fim ) and adverse events . the results of this trial are expected to clarify the synergistic effect of acupuncture and rehacom cognitive training on cognitive dysfunction after stroke . furthermore , to confirm whether combined or alone of acupuncture and rehacom cognitive training , is more effective than conventional treatment in the management of post-stroke cognitive dysfunction . chinese clinical trial registry : chictr-trc-@ .
25,099,775
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "anastomotic leakage of pancreaticojejunostomy ( pj ) remains the single most important source of morbidity after pancreaticoduodenectomy ( pd ) .", "the primary aim of this randomized clinical trial comparing pg with pj after pd was to test the hypothesis that invaginated pg would result in a lower rate and severity of pancreatic fistula .", "patients undergoing pd were randomized to receive either a duct-to-duct pj or a double-layer invaginated pg .", "the primary endpoint was the rate of pancreatic fistula , using the definition of the international study group on pancreatic fistula .", "secondary endpoints were the evaluation of severe abdominal complications ( clavien-dindo grade iiia or above ) , endocrine and exocrine function .", "of @ patients randomized , @ underwent pj and @ had pg .", "the incidence of pancreatic fistula was significantly higher following pj than for pg ( @ of @ versus @ of @ respectively ; p = @ ) , as was the severity of pancreatic fistula ( grade a : @ versus @ per cent ; grade b-c : @ versus @ per cent ; p = @ ) .", "the hospital readmission rate for complications was significantly lower after pg ( @ versus @ per cent ; p = @ ) , weight loss was lower ( p = @ ) and exocrine function better ( p = @ ) .", "the rate and severity of pancreatic fistula was significantly lower with this pg technique compared with that following pj .", "isrctn@ ( http://www.controlled-trials.com ) ." ]
anastomotic leakage of pancreaticojejunostomy ( pj ) remains the single most important source of morbidity after pancreaticoduodenectomy ( pd ) . the primary aim of this randomized clinical trial comparing pg with pj after pd was to test the hypothesis that invaginated pg would result in a lower rate and severity of pancreatic fistula . patients undergoing pd were randomized to receive either a duct-to-duct pj or a double-layer invaginated pg . the primary endpoint was the rate of pancreatic fistula , using the definition of the international study group on pancreatic fistula . secondary endpoints were the evaluation of severe abdominal complications ( clavien-dindo grade iiia or above ) , endocrine and exocrine function . of @ patients randomized , @ underwent pj and @ had pg . the incidence of pancreatic fistula was significantly higher following pj than for pg ( @ of @ versus @ of @ respectively ; p = @ ) , as was the severity of pancreatic fistula ( grade a : @ versus @ per cent ; grade b-c : @ versus @ per cent ; p = @ ) . the hospital readmission rate for complications was significantly lower after pg ( @ versus @ per cent ; p = @ ) , weight loss was lower ( p = @ ) and exocrine function better ( p = @ ) . the rate and severity of pancreatic fistula was significantly lower with this pg technique compared with that following pj . isrctn@ ( http://www.controlled-trials.com ) .
24,264,781
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "predictors of outcome after aneurysmal subarachnoid hemorrhage have been determined previously through hypothesis-driven methods that often exclude putative covariates and require a priori knowledge of potential confounders .", "here , we apply a data-driven approach , principal component analysis , to identify baseline patient phenotypes that may predict neurological outcomes .", "principal component analysis was performed on @ subjects enrolled in a prospective randomized trial of clazosentan for the prevention of angiographic vasospasm .", "correlation matrices were created using a combination of pearson , polyserial , and polychoric regressions among @ variables .", "scores of significant components ( with eigenvalues > @ ) were included in multivariate logistic regression models with incidence of severe angiographic vasospasm , delayed ischemic neurological deficit , and long-term outcome as outcomes of interest .", "sixteen significant principal components accounting for @ % of the variance were identified .", "a single component dominated by the patients ' initial hemodynamic status , world federation of neurosurgical societies score , neurological injury , and initial neutrophil/leukocyte counts was significantly associated with poor outcome .", "two additional components were associated with angiographic vasospasm , of which one was also associated with delayed ischemic neurological deficit .", "the first was dominated by the aneurysm-securing procedure , subarachnoid clot clearance , and intracerebral hemorrhage , whereas the second had high contributions from markers of anemia and albumin levels .", "principal component analysis , a data-driven approach , identified patient phenotypes that are associated with worse neurological outcomes .", "such data reduction methods may provide a better approximation of unique patient phenotypes and may inform clinical care as well as patient recruitment into clinical trials .", "http://www.clinicaltrials.gov .", "unique identifier : nct@ ." ]
predictors of outcome after aneurysmal subarachnoid hemorrhage have been determined previously through hypothesis-driven methods that often exclude putative covariates and require a priori knowledge of potential confounders . here , we apply a data-driven approach , principal component analysis , to identify baseline patient phenotypes that may predict neurological outcomes . principal component analysis was performed on @ subjects enrolled in a prospective randomized trial of clazosentan for the prevention of angiographic vasospasm . correlation matrices were created using a combination of pearson , polyserial , and polychoric regressions among @ variables . scores of significant components ( with eigenvalues > @ ) were included in multivariate logistic regression models with incidence of severe angiographic vasospasm , delayed ischemic neurological deficit , and long-term outcome as outcomes of interest . sixteen significant principal components accounting for @ % of the variance were identified . a single component dominated by the patients ' initial hemodynamic status , world federation of neurosurgical societies score , neurological injury , and initial neutrophil/leukocyte counts was significantly associated with poor outcome . two additional components were associated with angiographic vasospasm , of which one was also associated with delayed ischemic neurological deficit . the first was dominated by the aneurysm-securing procedure , subarachnoid clot clearance , and intracerebral hemorrhage , whereas the second had high contributions from markers of anemia and albumin levels . principal component analysis , a data-driven approach , identified patient phenotypes that are associated with worse neurological outcomes . such data reduction methods may provide a better approximation of unique patient phenotypes and may inform clinical care as well as patient recruitment into clinical trials . http://www.clinicaltrials.gov . unique identifier : nct@ .
24,425,125
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "to evaluate the effects of an al ( @ + ) - and mg ( @ + ) - containing antacid , ferrous sulfate , and calcium carbonate on the absorption of nemonoxacin in healthy humans .", "two single-dose , open-label , randomized , crossover studies were conducted in @ healthy male chinese volunteers ( @ per study ) .", "in study @ , the subjects orally received nemonoxacin ( @ mg ) alone , or an antacid ( containing @ mg of al ( @ + ) and @ mg of mg ( @ + ) ) plus nemonoxacin administered @ h before , concomitantly or @ h after the antacid .", "in study @ , the subjects orally received nemonoxacin ( @ mg ) alone , or nemonoxacin concomitantly with ferrous sulfate ( containing @ mg of fe ( @ + ) ) or calcium carbonate ( containing @ mg of ca ( @ + ) ) .", "concomitant administration of nemonoxacin with the antacid significantly decreased the area under the concentration-time curve from time @ to infinity ( auc@ - ) for nemonoxacin by @ % , the maximum concentration ( cmax ) by @ % , and urine recovery ( ae ) by @ % .", "administration of nemonoxacin @ h after the antacid decreased the auc@ - for nemonoxacin by @ % , cmax by @ % , and ae by @ % .", "administration of nemonoxacin @ h before the antacid did not affect the absorption of nemonoxacin .", "administration of nemonoxacin concomitantly with ferrous sulfate markedly decreased auc@ - by @ % , cmax by @ % , and ae by @ % , while concomitant administration of nemonoxacin with calcium carbonate mildly decreased auc@ - by @ % , cmax by @ % , and ae by @ % .", "metal ions , al ( @ + ) , mg ( @ + ) , and fe ( @ + ) markedly decreased the absorption of nemonoxacin in healthy chinese males , whereas ca ( @ + ) had much weaker effects .", "to avoid the effects of al ( @ + ) and mg ( @ + ) - containing drugs , nemonoxacin should be administered @ h before them ." ]
to evaluate the effects of an al ( @ + ) - and mg ( @ + ) - containing antacid , ferrous sulfate , and calcium carbonate on the absorption of nemonoxacin in healthy humans . two single-dose , open-label , randomized , crossover studies were conducted in @ healthy male chinese volunteers ( @ per study ) . in study @ , the subjects orally received nemonoxacin ( @ mg ) alone , or an antacid ( containing @ mg of al ( @ + ) and @ mg of mg ( @ + ) ) plus nemonoxacin administered @ h before , concomitantly or @ h after the antacid . in study @ , the subjects orally received nemonoxacin ( @ mg ) alone , or nemonoxacin concomitantly with ferrous sulfate ( containing @ mg of fe ( @ + ) ) or calcium carbonate ( containing @ mg of ca ( @ + ) ) . concomitant administration of nemonoxacin with the antacid significantly decreased the area under the concentration-time curve from time @ to infinity ( auc@ - ) for nemonoxacin by @ % , the maximum concentration ( cmax ) by @ % , and urine recovery ( ae ) by @ % . administration of nemonoxacin @ h after the antacid decreased the auc@ - for nemonoxacin by @ % , cmax by @ % , and ae by @ % . administration of nemonoxacin @ h before the antacid did not affect the absorption of nemonoxacin . administration of nemonoxacin concomitantly with ferrous sulfate markedly decreased auc@ - by @ % , cmax by @ % , and ae by @ % , while concomitant administration of nemonoxacin with calcium carbonate mildly decreased auc@ - by @ % , cmax by @ % , and ae by @ % . metal ions , al ( @ + ) , mg ( @ + ) , and fe ( @ + ) markedly decreased the absorption of nemonoxacin in healthy chinese males , whereas ca ( @ + ) had much weaker effects . to avoid the effects of al ( @ + ) and mg ( @ + ) - containing drugs , nemonoxacin should be administered @ h before them .
25,327,812
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study was conducted to compare the effectiveness of pettlep-based imagery , and traditional imagery interventions , on performance of passing skill in volleyball .", "@ beginners male volleyball players ( mage = @ years , sd = @ years ) with @-@ months practice experience were randomly assigned to one of three groups : physical practice + pettlep imagery ( pp+pi ) ( n. = @ ) , physical practice + traditional imagery ( n. = @ ) , and physical practice only ( pp ; n. = @ ) .", "subjects in the pp+pi group applied the seven components of pettlep imagery training ; whereas subjects in the pp+ti engaged in a relaxation session before imagery and used response laden motor imagery scripts .", "the two groups completed @ minutes of imagery training followed immediately by @ minutes of `` passing '' practice three times per week .", "the pp group completed only @ minutes of `` passing '' practice three times per week .", "each group performed its respective tasks for @ weeks .", "a pre-test took place during the first practice session in which `` passing '' was assessed .", "after the @-week practice program , a post-test took place followed by a retention test , one `` no-practice '' week later .", "all groups improved significantly ( p < @ ) from pre - to post-test and retention test .", "however , as hypothesised the pp+pi group improved more ( p < @ ) than the pp+ti and pp groups .", "the findings , therefore , support the effectiveness of pettlep imagery in enhancing performance of passing skill in volleyball when combined with physical practice ." ]
this study was conducted to compare the effectiveness of pettlep-based imagery , and traditional imagery interventions , on performance of passing skill in volleyball . @ beginners male volleyball players ( mage = @ years , sd = @ years ) with @-@ months practice experience were randomly assigned to one of three groups : physical practice + pettlep imagery ( pp+pi ) ( n. = @ ) , physical practice + traditional imagery ( n. = @ ) , and physical practice only ( pp ; n. = @ ) . subjects in the pp+pi group applied the seven components of pettlep imagery training ; whereas subjects in the pp+ti engaged in a relaxation session before imagery and used response laden motor imagery scripts . the two groups completed @ minutes of imagery training followed immediately by @ minutes of `` passing '' practice three times per week . the pp group completed only @ minutes of `` passing '' practice three times per week . each group performed its respective tasks for @ weeks . a pre-test took place during the first practice session in which `` passing '' was assessed . after the @-week practice program , a post-test took place followed by a retention test , one `` no-practice '' week later . all groups improved significantly ( p < @ ) from pre - to post-test and retention test . however , as hypothesised the pp+pi group improved more ( p < @ ) than the pp+ti and pp groups . the findings , therefore , support the effectiveness of pettlep imagery in enhancing performance of passing skill in volleyball when combined with physical practice .
25,642,682
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this multicenter , randomized , open-labeled , clinical trial evaluated the efficacy and safety of cisplatin/@-fluorouracil ( @-fu ) hepatic arterial infusion chemotherapy ( cf-haic ) versus adriamycin adding to cf-haic ( acf-haic ) in advanced hcc patients .", "fifty-six patients with advanced hcc were randomized to two treatment groups : ( @ ) cf-haic group -lsb- n = @ , @-fu , @ mg/m ( @ ) on days @-@ , and cisplatin , @ mg/m ( @ ) on day @ -rsb- and ( @ ) acf-haic group -lsb- n = @ , adriamycin , @ mg/m ( @ ) on day @ , @-fu , @ mg/m ( @ ) on days @-@ , and cisplatin , @ mg/m ( @ ) on day @ -rsb- every @ weeks via an implantable port system .", "primary efficacy endpoint was overall survival ( os ) .", "treatment response and time to progression were secondary endpoints .", "treatment response rates did not differ significantly between the two treatment groups .", "time to progression ( @ vs. @ months , p = @ ) and os ( @ vs. @ months , p = @ ) were not significantly different .", "when the factors affecting patient os were analyzed , disease control rate -lsb- p < @ , hr @ ( @ % ci @-@ @ ) -rsb- was independently associated with os .", "age ( @ years ) and serum afp level ( @ ng/dl ) also were significant factors for os -lsb- p = @ , hr @ ( @ % ci @-@ @ ) , p = @ , hr @ ( @ % ci @-@ @ ) , respectively -rsb- .", "grade @ treatment-related toxicity and mortality was not observed in both groups .", "although both haic regimens are safe and effective in patients with advanced hcc , haic adding adriamycin did not show delayed tumor progression and survival benefit compared to cf-haic in advanced hcc ." ]
this multicenter , randomized , open-labeled , clinical trial evaluated the efficacy and safety of cisplatin/@-fluorouracil ( @-fu ) hepatic arterial infusion chemotherapy ( cf-haic ) versus adriamycin adding to cf-haic ( acf-haic ) in advanced hcc patients . fifty-six patients with advanced hcc were randomized to two treatment groups : ( @ ) cf-haic group -lsb- n = @ , @-fu , @ mg/m ( @ ) on days @-@ , and cisplatin , @ mg/m ( @ ) on day @ -rsb- and ( @ ) acf-haic group -lsb- n = @ , adriamycin , @ mg/m ( @ ) on day @ , @-fu , @ mg/m ( @ ) on days @-@ , and cisplatin , @ mg/m ( @ ) on day @ -rsb- every @ weeks via an implantable port system . primary efficacy endpoint was overall survival ( os ) . treatment response and time to progression were secondary endpoints . treatment response rates did not differ significantly between the two treatment groups . time to progression ( @ vs. @ months , p = @ ) and os ( @ vs. @ months , p = @ ) were not significantly different . when the factors affecting patient os were analyzed , disease control rate -lsb- p < @ , hr @ ( @ % ci @-@ @ ) -rsb- was independently associated with os . age ( @ years ) and serum afp level ( @ ng/dl ) also were significant factors for os -lsb- p = @ , hr @ ( @ % ci @-@ @ ) , p = @ , hr @ ( @ % ci @-@ @ ) , respectively -rsb- . grade @ treatment-related toxicity and mortality was not observed in both groups . although both haic regimens are safe and effective in patients with advanced hcc , haic adding adriamycin did not show delayed tumor progression and survival benefit compared to cf-haic in advanced hcc .
25,663,125
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to assess the effectiveness and safety on post-stroke dysphagia in chronic stage treated with magnetic-ball sticking therapy at the auricular points .", "ninety cases of post-apoplexy dysphagia in chronic stage were randomized into an auricular points group and an acupuncture group .", "in the auricular points group , the magnetic-ball sticking therapy was applied to subcortex ( pizhixia , at@ ) , brainstem ( naogan , at ( @,@ i ) ) , mouth ( kou , co@ ) , cheek ( mianjia , lo ( @,@ i ) ) , tongue ( she , lo@ ) and throat ( yanhou , tg@ ) on one ear each time , and were changed on the other ear once every @ days .", "in the acupucnture group , acupuncture was applied to feng-chi ( gb @ ) , yifeng ( te @ ) , shanglianquan ( extra ) , jinjin ( ex-hn @ ) , yuye ( ex-hn @ ) , shuigou ( gv @ ) and tongli ( th @ ) , etc. .", "the needles were retained for @ min in each treatment .", "the treatment was gi-yen once a day in the two groups and the treatment of @ days made one session .", "there was @ day at an interval among the sessions .", "totally , @ sessions of treatment were required .", "the video fluoroscopic swallowing study ( vfss ) was performed for @ kinds of food with different properties and shapes in each patient .", "the main indices were rosenbek penetration-aspiration score , oral-retaining score and throat-retaining score .", "the efficacy , and the incidences of aspiration pneumonia and malnutrition were compared between the two groups .", "the nutrition indices were compared before and after treatment between the two groups , such as the skinfold thickness of triceps brachii muscle , serum albumin and peralbumin .", "in @ days of treatment , in the auricular points group , the @ ml liquid loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately .", "the @ ml liquid loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately .", "the @ ml paste loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately .", "the @/@ cake-form loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately .", "the incidence of aspiration pneumonia was @ % ( @/@ ) in the auricular points group , which was lower than @ % ( @/@ ) in the acupuncture group ( p < @ ) .", "the incidence of malnutrition was @ % ( @/@ ) in the auricular points group , which was lower than @ % ( @/@ ) in the acupuncture group ( p < @ ) .", "in @ days of treatment , the results of the skinfold thickness of triceps brachii muscle and serum albumin in the auricular points group were better than those in the acupuncture group ( both p < @ ) .", "the magnetic-ball sticking therapy at auricular points achieves the definite efficacy on post-stoke dysphagia in chronic stage and decreases the incidences of aspiration pneumonia and malnutrition .", "the efficacy of this therapy is better than acupuncture ." ]
to assess the effectiveness and safety on post-stroke dysphagia in chronic stage treated with magnetic-ball sticking therapy at the auricular points . ninety cases of post-apoplexy dysphagia in chronic stage were randomized into an auricular points group and an acupuncture group . in the auricular points group , the magnetic-ball sticking therapy was applied to subcortex ( pizhixia , at@ ) , brainstem ( naogan , at ( @,@ i ) ) , mouth ( kou , co@ ) , cheek ( mianjia , lo ( @,@ i ) ) , tongue ( she , lo@ ) and throat ( yanhou , tg@ ) on one ear each time , and were changed on the other ear once every @ days . in the acupucnture group , acupuncture was applied to feng-chi ( gb @ ) , yifeng ( te @ ) , shanglianquan ( extra ) , jinjin ( ex-hn @ ) , yuye ( ex-hn @ ) , shuigou ( gv @ ) and tongli ( th @ ) , etc. . the needles were retained for @ min in each treatment . the treatment was gi-yen once a day in the two groups and the treatment of @ days made one session . there was @ day at an interval among the sessions . totally , @ sessions of treatment were required . the video fluoroscopic swallowing study ( vfss ) was performed for @ kinds of food with different properties and shapes in each patient . the main indices were rosenbek penetration-aspiration score , oral-retaining score and throat-retaining score . the efficacy , and the incidences of aspiration pneumonia and malnutrition were compared between the two groups . the nutrition indices were compared before and after treatment between the two groups , such as the skinfold thickness of triceps brachii muscle , serum albumin and peralbumin . in @ days of treatment , in the auricular points group , the @ ml liquid loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately . the @ ml liquid loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately . the @ ml paste loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately . the @/@ cake-form loversol rosenbek penetration-aspiration score ( @ + / - @ ) , oral-retaining score ( @ + / - @ ) and throat-retaining score ( @ + / - @ ) were all lower than those ( @ + / - @ , @ + / - @ , @ + / - @ ) in the acupuncture group separately . the incidence of aspiration pneumonia was @ % ( @/@ ) in the auricular points group , which was lower than @ % ( @/@ ) in the acupuncture group ( p < @ ) . the incidence of malnutrition was @ % ( @/@ ) in the auricular points group , which was lower than @ % ( @/@ ) in the acupuncture group ( p < @ ) . in @ days of treatment , the results of the skinfold thickness of triceps brachii muscle and serum albumin in the auricular points group were better than those in the acupuncture group ( both p < @ ) . the magnetic-ball sticking therapy at auricular points achieves the definite efficacy on post-stoke dysphagia in chronic stage and decreases the incidences of aspiration pneumonia and malnutrition . the efficacy of this therapy is better than acupuncture .
24,673,044
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "several characteristics of bone-targeted agents are considered when making treatment decisions .", "this study evaluated physicians ' therapy preferences for preventing skeletal-related events ( sres ) in patients with bone metastases secondary to solid tumors .", "a web-enabled , discrete-choice experiment online survey was conducted among physicians who treated patients with bone metastases and solid tumors in the united states .", "respondents chose between pairs of hypothetical medications defined by combinations of six attributes at varying levels for two hypothetical patients .", "preference weights for attribute levels were estimated using a random-parameters logit model .", "in total , @ physicians completed the survey .", "their mean age was @ years , @ % were in practice for more than @ years , @ % were oncologists , and @ % treated @ or fewer patients with bone metastases weekly .", "out-of-pocket cost to patients was the most important attribute overall .", "among clinical outcomes , time to first sre and risk of renal impairment were the most important attributes .", "statistically significant preferences were observed for all attribute levels for time to first sre , risk of renal impairment , and mode of administration .", "predicted choice probability analysis showed that physicians preferred a hypothetical medication with attributes similar to those of denosumab over one with attributes similar to those of zoledronic acid .", "physicians indicated that clinical attributes are important when considering bone-targeting therapy for bone metastases , but consistent with the current health care landscape , patient out-of-pocket cost was the most important .", "with health care costs being increasingly shifted to patients , physicians require accurate information about co-pays and assistance programs to avoid patients receiving less costly , yet potentially inferior , treatment ." ]
several characteristics of bone-targeted agents are considered when making treatment decisions . this study evaluated physicians ' therapy preferences for preventing skeletal-related events ( sres ) in patients with bone metastases secondary to solid tumors . a web-enabled , discrete-choice experiment online survey was conducted among physicians who treated patients with bone metastases and solid tumors in the united states . respondents chose between pairs of hypothetical medications defined by combinations of six attributes at varying levels for two hypothetical patients . preference weights for attribute levels were estimated using a random-parameters logit model . in total , @ physicians completed the survey . their mean age was @ years , @ % were in practice for more than @ years , @ % were oncologists , and @ % treated @ or fewer patients with bone metastases weekly . out-of-pocket cost to patients was the most important attribute overall . among clinical outcomes , time to first sre and risk of renal impairment were the most important attributes . statistically significant preferences were observed for all attribute levels for time to first sre , risk of renal impairment , and mode of administration . predicted choice probability analysis showed that physicians preferred a hypothetical medication with attributes similar to those of denosumab over one with attributes similar to those of zoledronic acid . physicians indicated that clinical attributes are important when considering bone-targeting therapy for bone metastases , but consistent with the current health care landscape , patient out-of-pocket cost was the most important . with health care costs being increasingly shifted to patients , physicians require accurate information about co-pays and assistance programs to avoid patients receiving less costly , yet potentially inferior , treatment .
25,595,237
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "despite their positive motivation to quit , many smokers do not attempt to quit or relapse soon after their quit attempt .", "this study investigated the predictors of successful and unsuccessful quit attempts among smokers motivated to quit smoking .", "we conducted secondary data analysis among respondents motivated to quit within @ months , randomized to the control group ( n = @ ) of a web-based smoking cessation intervention study .", "using chi-square tests and anova with tukey post hoc comparisons , we investigated baseline differences by smoking status ( successful quitter/relapse/persistent smoker ) assessed after @ weeks ( n = @ ) .", "to identify independent predictors of smoking status , multivariate multinomial logistic regression analyses were conducted .", "successful quitters at @-week follow-up ( @ % ) had reported significantly higher baseline levels of self-efficacy than relapsers ( @ % ) and persistent smokers ( @ % ) .", "furthermore , both successful quitters and relapsers had reported a significantly higher baseline intention to quit than persistent smokers and successful quitters had reported significantly more preparatory planning at baseline than persistent smokers .", "results from regression analyses showed that smokers ' baseline intention to quit positively predicted quit attempts reported after @ weeks , while self-efficacy positively predicted quit attempt success .", "different factors appear to play a role in predicting quit attempts and their success .", "whereas intention to quit only appeared to play a role in predicting quit attempts , self-efficacy was the main factor predicting quit attempt success .", "more research is needed to determine the role of preparatory planning and plan enactment and to investigate whether these findings can be replicated on the long term ." ]
despite their positive motivation to quit , many smokers do not attempt to quit or relapse soon after their quit attempt . this study investigated the predictors of successful and unsuccessful quit attempts among smokers motivated to quit smoking . we conducted secondary data analysis among respondents motivated to quit within @ months , randomized to the control group ( n = @ ) of a web-based smoking cessation intervention study . using chi-square tests and anova with tukey post hoc comparisons , we investigated baseline differences by smoking status ( successful quitter/relapse/persistent smoker ) assessed after @ weeks ( n = @ ) . to identify independent predictors of smoking status , multivariate multinomial logistic regression analyses were conducted . successful quitters at @-week follow-up ( @ % ) had reported significantly higher baseline levels of self-efficacy than relapsers ( @ % ) and persistent smokers ( @ % ) . furthermore , both successful quitters and relapsers had reported a significantly higher baseline intention to quit than persistent smokers and successful quitters had reported significantly more preparatory planning at baseline than persistent smokers . results from regression analyses showed that smokers ' baseline intention to quit positively predicted quit attempts reported after @ weeks , while self-efficacy positively predicted quit attempt success . different factors appear to play a role in predicting quit attempts and their success . whereas intention to quit only appeared to play a role in predicting quit attempts , self-efficacy was the main factor predicting quit attempt success . more research is needed to determine the role of preparatory planning and plan enactment and to investigate whether these findings can be replicated on the long term .
24,837,754
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "airseal is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide ( co ) recirculation during laparoscopic surgery .", "comparison data to standard co pressure pneumoperitoneum insufflators is scarce .", "the aim of this study is to evaluate the potential advantages of airseal compared to a standard co insufflator .", "this is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy , colorectal surgery and hernia repair with airseal ( group a ) versus a standard co pressure insufflator ( group s ) .", "patients are randomized using a web-based central randomization and registration system .", "primary outcome measures will be operative time and level of postoperative shoulder pain by using the visual analog score ( vas ) .", "secondary outcomes include the evaluation of immunological values through blood tests , anesthesiological parameters , surgical side effects and length of hospital stay .", "taking into account an expected dropout rate of @ % , the total number of patients is @ ( n = @ per group ) .", "all tests will be two-sided with a confidence level of @ % ( p < @ ) .", "the duration of an operation is an important factor in reducing the patient 's exposure to co pneumoperitoneum and its adverse consequences .", "this trial will help to evaluate if the announced advantages of airseal , such as clear sight of the operative site and an exceptionally stable working environment , will facilitate the course of selected procedures and influence operation time and patients clinical outcome .", "clinicaltrials.gov nct@ , registered @ november @ ." ]
airseal is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide ( co ) recirculation during laparoscopic surgery . comparison data to standard co pressure pneumoperitoneum insufflators is scarce . the aim of this study is to evaluate the potential advantages of airseal compared to a standard co insufflator . this is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy , colorectal surgery and hernia repair with airseal ( group a ) versus a standard co pressure insufflator ( group s ) . patients are randomized using a web-based central randomization and registration system . primary outcome measures will be operative time and level of postoperative shoulder pain by using the visual analog score ( vas ) . secondary outcomes include the evaluation of immunological values through blood tests , anesthesiological parameters , surgical side effects and length of hospital stay . taking into account an expected dropout rate of @ % , the total number of patients is @ ( n = @ per group ) . all tests will be two-sided with a confidence level of @ % ( p < @ ) . the duration of an operation is an important factor in reducing the patient 's exposure to co pneumoperitoneum and its adverse consequences . this trial will help to evaluate if the announced advantages of airseal , such as clear sight of the operative site and an exceptionally stable working environment , will facilitate the course of selected procedures and influence operation time and patients clinical outcome . clinicaltrials.gov nct@ , registered @ november @ .
24,950,720
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to compare the difference in the clinical efficacy on perennial allergic rhinitis between three nasal points acupuncture therapy and the oral administration of loratadine so as to provide the better acupuncture program in clinical treatment .", "sixty cases were randomized into an acupuncture group ( @ cases ) and a medication group ( @ cases ) .", "in the acupuncture group , acupuncture was applied to three nasal points -lsb- yingxiang ( li @ ) , yintang ( ex-hn @ ) , bitong ( extra ) -rsb- and acupoints selected by syndrome differentiation .", "acupuncture was given once every two days , three times a week , for @ weeks totally .", "in the medication group , loratadine was prescribed for oral administration , @ mg every day , for @ weeks .", "the symptom and physical sign scores before and after treatment , as well the short-term and long-term efficacy were compared between the two groups .", "the total effective rate was @ % ( @/@ ) in the acupuncture group and was @ % ( @/@ ) in the medication group after treatment .", "the efficacy was similar between the two groups ( p > @ ) .", "in follow-up , the total effective rate was @ % ( @/@ ) in the acupuncture group , which was better than @ % ( @/@ , p < @ ) in the medication group .", "the scores of symptoms and physical signs after treatment and in follow-up were all reduced apparently as compared with those before treatment in the patients of the two groups ( all p < @ ) .", "the scores of symptoms and physical signs were reduced more apparently in the acupuncture group as compared with those in the medication group in follow-up ( all p < @ ) .", "the acupuncture at three nasal points and the acupoints selected by syndrome differentiation achieves the similar short-term efficacy on perennial allergic rhinitis as compared with the oral administration of loratadine .", "the acupuncture therapy presents the obvious advantages on long-term efficacy ." ]
to compare the difference in the clinical efficacy on perennial allergic rhinitis between three nasal points acupuncture therapy and the oral administration of loratadine so as to provide the better acupuncture program in clinical treatment . sixty cases were randomized into an acupuncture group ( @ cases ) and a medication group ( @ cases ) . in the acupuncture group , acupuncture was applied to three nasal points -lsb- yingxiang ( li @ ) , yintang ( ex-hn @ ) , bitong ( extra ) -rsb- and acupoints selected by syndrome differentiation . acupuncture was given once every two days , three times a week , for @ weeks totally . in the medication group , loratadine was prescribed for oral administration , @ mg every day , for @ weeks . the symptom and physical sign scores before and after treatment , as well the short-term and long-term efficacy were compared between the two groups . the total effective rate was @ % ( @/@ ) in the acupuncture group and was @ % ( @/@ ) in the medication group after treatment . the efficacy was similar between the two groups ( p > @ ) . in follow-up , the total effective rate was @ % ( @/@ ) in the acupuncture group , which was better than @ % ( @/@ , p < @ ) in the medication group . the scores of symptoms and physical signs after treatment and in follow-up were all reduced apparently as compared with those before treatment in the patients of the two groups ( all p < @ ) . the scores of symptoms and physical signs were reduced more apparently in the acupuncture group as compared with those in the medication group in follow-up ( all p < @ ) . the acupuncture at three nasal points and the acupoints selected by syndrome differentiation achieves the similar short-term efficacy on perennial allergic rhinitis as compared with the oral administration of loratadine . the acupuncture therapy presents the obvious advantages on long-term efficacy .
25,675,568
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "comparing the overall and differential effects of psychodynamic psychotherapy ( pdt ) versus cognitive behavior therapy ( cbt ) for social anxiety disorder ( sad ) .", "patients with a primary sad ( n = @ ) were randomly assigned to pdt ( n = @ ) or cbt ( n = @ ) .", "both pdt and cbt consisted of up to @ sessions ( average pdt @ and cbt @ sessions ) .", "assessments took place at waitlist : pretest , after @ and @ weeks for those who received longer treatment : posttest , @-month and @-year follow-up .", "changes in the main outcome measure self-reported social anxiety composite , as well as in other psychopathology , social skills , negative social beliefs , public self-consciousness , defense mechanisms , personal goals , independent rater 's judgments of sad and general improvement , and approach behavior during an objective test , were analyzed using multilevel analysis .", "no improvement occurred during waitlist .", "treatments were highly efficacious , with large within-subject effect sizes for social anxiety , but no differences between pdt and cbt on general and treatment-specific measures occurred .", "remission rates were over @ % and similar for pdt and cbt .", "personality disorders did not influence the effects of pdt or cbt .", "pdt and cbt are both effective approaches for sad .", "further research is needed on the cost-effectiveness of pdt versus cbt , on different lengths pdt , and on patient preferences and their relationship to outcome of pdt versus cbt ." ]
comparing the overall and differential effects of psychodynamic psychotherapy ( pdt ) versus cognitive behavior therapy ( cbt ) for social anxiety disorder ( sad ) . patients with a primary sad ( n = @ ) were randomly assigned to pdt ( n = @ ) or cbt ( n = @ ) . both pdt and cbt consisted of up to @ sessions ( average pdt @ and cbt @ sessions ) . assessments took place at waitlist : pretest , after @ and @ weeks for those who received longer treatment : posttest , @-month and @-year follow-up . changes in the main outcome measure self-reported social anxiety composite , as well as in other psychopathology , social skills , negative social beliefs , public self-consciousness , defense mechanisms , personal goals , independent rater 's judgments of sad and general improvement , and approach behavior during an objective test , were analyzed using multilevel analysis . no improvement occurred during waitlist . treatments were highly efficacious , with large within-subject effect sizes for social anxiety , but no differences between pdt and cbt on general and treatment-specific measures occurred . remission rates were over @ % and similar for pdt and cbt . personality disorders did not influence the effects of pdt or cbt . pdt and cbt are both effective approaches for sad . further research is needed on the cost-effectiveness of pdt versus cbt , on different lengths pdt , and on patient preferences and their relationship to outcome of pdt versus cbt .
24,577,880
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to examine how prenatal drug exposure ( pde ) to heroin/cocaine and behavioral problems relate to adolescent drug experimentation .", "the sample included african-american adolescents ( mean age = @ years , sd = @ ) with pde ( n = @ ) and a nonexposed community comparison ( n = @ ) .", "pde status was determined at delivery through toxicology analysis and maternal report .", "internalizing/externalizing problems were assessed during adolescence with the behavior assessment system for children , second edition .", "drug experimentation was assessed by adolescent report and urine analysis .", "logistic regression evaluated the likelihood of drug experimentation related to pde and behavioral problems , adjusting for age , gender , pde , perceived peer drug use , and caregiver drug use .", "interaction terms examined gender modification .", "sixty-seven subjects ( @ % ) used drugs : @ ( @ % ) used tobacco/alcohol only and @ ( @ % ) used marijuana/illegal drugs .", "ninety-four subjects ( @ % ) perceived peer drug use .", "pde significantly increased the risk of tobacco/alcohol experimentation ( odds ratio = @ , @ % confidence interval -lsb- ci -rsb- @-@ @ , p = @ ) but not after covariate adjustment ( adjusted odds ratio -lsb- aor -rsb- = @ , @ % ci @ -@ , p > @ ) .", "pde was not related to the overall or marijuana/illegal drug experimentation .", "the likelihood of overall drug experimentation was doubled per sd increase in externalizing problems ( aor = @ , @ % ci @-@ @ , p = @ ) and , among girls , @ times greater ( aor = @ , @ % ci @-@ @ , p = @ ) per sd increase in internalizing problems .", "age and perceived peer drug use were significant covariates .", "drug experimentation was relatively common ( @ % ) , especially in the context of externalizing problems , internalizing problems ( girls only ) , older age , and perceived peer drug use .", "findings support the problem behavior theory and suggest that adolescent drug prevention addresses behavioral problems and promotes prosocial peer groups ." ]
to examine how prenatal drug exposure ( pde ) to heroin/cocaine and behavioral problems relate to adolescent drug experimentation . the sample included african-american adolescents ( mean age = @ years , sd = @ ) with pde ( n = @ ) and a nonexposed community comparison ( n = @ ) . pde status was determined at delivery through toxicology analysis and maternal report . internalizing/externalizing problems were assessed during adolescence with the behavior assessment system for children , second edition . drug experimentation was assessed by adolescent report and urine analysis . logistic regression evaluated the likelihood of drug experimentation related to pde and behavioral problems , adjusting for age , gender , pde , perceived peer drug use , and caregiver drug use . interaction terms examined gender modification . sixty-seven subjects ( @ % ) used drugs : @ ( @ % ) used tobacco/alcohol only and @ ( @ % ) used marijuana/illegal drugs . ninety-four subjects ( @ % ) perceived peer drug use . pde significantly increased the risk of tobacco/alcohol experimentation ( odds ratio = @ , @ % confidence interval -lsb- ci -rsb- @-@ @ , p = @ ) but not after covariate adjustment ( adjusted odds ratio -lsb- aor -rsb- = @ , @ % ci @ -@ , p > @ ) . pde was not related to the overall or marijuana/illegal drug experimentation . the likelihood of overall drug experimentation was doubled per sd increase in externalizing problems ( aor = @ , @ % ci @-@ @ , p = @ ) and , among girls , @ times greater ( aor = @ , @ % ci @-@ @ , p = @ ) per sd increase in internalizing problems . age and perceived peer drug use were significant covariates . drug experimentation was relatively common ( @ % ) , especially in the context of externalizing problems , internalizing problems ( girls only ) , older age , and perceived peer drug use . findings support the problem behavior theory and suggest that adolescent drug prevention addresses behavioral problems and promotes prosocial peer groups .
24,768,161
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "intra-articular triamcinolone in combination with dmards may be able to achieve faster and tighter control of disease activity in early rheumatoid arthritis that may be the key to preventing or minimizing later deformities .", "to compare the efficacy of a combination of disease modifying anti-rheumatoid drugs ( dmards ) with intra-articular glucocorticoids versus only dmards in a group of patients with early rheumatoid arthritis ( ra ) .", "fifty patients diagnosed as rheumatoid arthritis ( ra ) by american rheumatology association ( ara ) criteria ( @ ) with disease duration less than two years were randomized into two groups .", "the control group received a combination of methotrexate @ mg daily with sulfasalazine @ gm daily for @ months and the study group received the above combination along with intra-articular injections of triamcinolone acetate ( @ mg per ml ) in each of the swollen joints at the start of the study .", "outcome was assessed in terms of disease activity score ( das-@ ) , american college of rheumatology ( acr ) @/@/@ criteria and number of rescue medications used at the end of @ months .", "the study group had significant reductions in das @ scores ( @ versus @ in control group ) and significantly more subjects achieved the acr @/@/@ criteria at the end of @ months ( @/@/@ % versus @/@/@ % ) secondary end-points like tender and swollen joint count , esr , early morning stiffness , health assessment questionnaire ( haq ) scores and general health status were significantly reduced in the study group .", "also , significantly lesser rescue medications were needed in the study group .", "combination of dmards with intra-articular corticosteroids is significantly better than dmards alone in early ra ." ]
intra-articular triamcinolone in combination with dmards may be able to achieve faster and tighter control of disease activity in early rheumatoid arthritis that may be the key to preventing or minimizing later deformities . to compare the efficacy of a combination of disease modifying anti-rheumatoid drugs ( dmards ) with intra-articular glucocorticoids versus only dmards in a group of patients with early rheumatoid arthritis ( ra ) . fifty patients diagnosed as rheumatoid arthritis ( ra ) by american rheumatology association ( ara ) criteria ( @ ) with disease duration less than two years were randomized into two groups . the control group received a combination of methotrexate @ mg daily with sulfasalazine @ gm daily for @ months and the study group received the above combination along with intra-articular injections of triamcinolone acetate ( @ mg per ml ) in each of the swollen joints at the start of the study . outcome was assessed in terms of disease activity score ( das-@ ) , american college of rheumatology ( acr ) @/@/@ criteria and number of rescue medications used at the end of @ months . the study group had significant reductions in das @ scores ( @ versus @ in control group ) and significantly more subjects achieved the acr @/@/@ criteria at the end of @ months ( @/@/@ % versus @/@/@ % ) secondary end-points like tender and swollen joint count , esr , early morning stiffness , health assessment questionnaire ( haq ) scores and general health status were significantly reduced in the study group . also , significantly lesser rescue medications were needed in the study group . combination of dmards with intra-articular corticosteroids is significantly better than dmards alone in early ra .
25,856,933
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the ipswich touch test is a novel method to detect subjects with diabetes with loss of foot sensation and is simple , safe , quick , and easy to perform and teach .", "this study determines whether it can be used by relatives and/or carers to detect reduced foot sensation in the setting of the patient 's home .", "the test involves lightly and briefly ( @-@ s ) touching the tips of the first , third and fifth toes of both feet with the index finger .", "reduced foot sensation was defined as @ insensate areas .", "patients due to attend clinic over a @-week period were invited by post .", "the invitation contained detailed instructions and a sheet for recording the results .", "the findings were compared with those obtained in clinic using the @-g monofilament at the same six sites .", "of @ patients ( @ males ) , @ % ( n = @ ) had @ insensate areas to @-g monofilament testing .", "compared with this , the ipswich touch test at home had a sensitivity of @ % and a specificity of @ % .", "the predictive values of detecting ` at-risk ' feet were positive at @ % and negative at @ % .", "the likelihood ratios were positive at @ and negative at @ .", "with clearly written instructions , this simple test can be used by non-professionals to accurately assess for loss of protective sensation .", "we believe that the ipswich touch test may also be a useful educational adjunct to improve awareness of diabetes foot disease in patients and relatives alike and empower them to seek appropriate care if sensation was found to be abnormal ." ]
the ipswich touch test is a novel method to detect subjects with diabetes with loss of foot sensation and is simple , safe , quick , and easy to perform and teach . this study determines whether it can be used by relatives and/or carers to detect reduced foot sensation in the setting of the patient 's home . the test involves lightly and briefly ( @-@ s ) touching the tips of the first , third and fifth toes of both feet with the index finger . reduced foot sensation was defined as @ insensate areas . patients due to attend clinic over a @-week period were invited by post . the invitation contained detailed instructions and a sheet for recording the results . the findings were compared with those obtained in clinic using the @-g monofilament at the same six sites . of @ patients ( @ males ) , @ % ( n = @ ) had @ insensate areas to @-g monofilament testing . compared with this , the ipswich touch test at home had a sensitivity of @ % and a specificity of @ % . the predictive values of detecting ` at-risk ' feet were positive at @ % and negative at @ % . the likelihood ratios were positive at @ and negative at @ . with clearly written instructions , this simple test can be used by non-professionals to accurately assess for loss of protective sensation . we believe that the ipswich touch test may also be a useful educational adjunct to improve awareness of diabetes foot disease in patients and relatives alike and empower them to seek appropriate care if sensation was found to be abnormal .
24,673,517
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the cellular immunity has a profound impact on the status of hepatitis c virus ( hcv ) infection .", "however , the response of cellular immunity on the virological response in patients with antiviral treatment remains largely unclear .", "we aimed to clarify the response of peripheral t cells and monocytes in chronic hepatitis c patients with antiviral treatment .", "patients with chronic hepatitis c were treated either with interferon alpha-@b plus ribavirin ( n = @ ) or with pegylated interferon alpha-@a plus ribavirin ( n = @ ) for up to @ weeks .", "frequencies of peripheral regulatory t-cells ( tregs ) , programmed death-@ ( pd-@ ) expressing cd@ + t-cells or cd@ + t-cells and toll-like receptor ( tlr ) @ expressing cd@ + monocytes were evaluated by flow cytometry in patients at baseline , @ and @ weeks following treatment and in @ healthy controls .", "frequencies of tregs , pd-@ and tlr@ expressing cells were higher in patients than those in control subjects ( p < @ ) .", "patients with complete early virological response ( cevr ) showed lower tregs , pd-@ expressing cd@ + or cd@ + t-cells than those without cevr at @ weeks ( p < @ ) .", "patients with low tlr@ expressing cd@ + monocytes at baseline had a high rate of cevr ( p < @ ) .", "low peripheral tlr@ expressing cd@ + monocytes at baseline could serve as a predictor for cevr of antiviral therapy in chronic hcv-infected patients .", "the cevr rates were significantly increased in the patients with reduced circulating tregs , pd-@ expressing cd@ + or cd@ + t-cells .", "chinese clinical trial registry chictr@ ." ]
the cellular immunity has a profound impact on the status of hepatitis c virus ( hcv ) infection . however , the response of cellular immunity on the virological response in patients with antiviral treatment remains largely unclear . we aimed to clarify the response of peripheral t cells and monocytes in chronic hepatitis c patients with antiviral treatment . patients with chronic hepatitis c were treated either with interferon alpha-@b plus ribavirin ( n = @ ) or with pegylated interferon alpha-@a plus ribavirin ( n = @ ) for up to @ weeks . frequencies of peripheral regulatory t-cells ( tregs ) , programmed death-@ ( pd-@ ) expressing cd@ + t-cells or cd@ + t-cells and toll-like receptor ( tlr ) @ expressing cd@ + monocytes were evaluated by flow cytometry in patients at baseline , @ and @ weeks following treatment and in @ healthy controls . frequencies of tregs , pd-@ and tlr@ expressing cells were higher in patients than those in control subjects ( p < @ ) . patients with complete early virological response ( cevr ) showed lower tregs , pd-@ expressing cd@ + or cd@ + t-cells than those without cevr at @ weeks ( p < @ ) . patients with low tlr@ expressing cd@ + monocytes at baseline had a high rate of cevr ( p < @ ) . low peripheral tlr@ expressing cd@ + monocytes at baseline could serve as a predictor for cevr of antiviral therapy in chronic hcv-infected patients . the cevr rates were significantly increased in the patients with reduced circulating tregs , pd-@ expressing cd@ + or cd@ + t-cells . chinese clinical trial registry chictr@ .
24,709,775
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "few randomized trials have compared the results of doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy .", "few studies have reported long-term results .", "the aim of this study is to evaluate the results of doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade iii hemorrhoids .", "this is a prospective randomized study registered at clinicaltrials.gov ( nct@ ) .", "a power analysis assessed the study 's sample size .", "patients were randomly assigned to undergo either hemorrhoidectomy or doppler-guided hemorrhoid dearterialization plus mucopexy .", "the test , mann-whitney u test , student t test , and a regression model were used , as appropriate .", "this study was conducted at the department of surgery , san raffaele scientific institute , milan , italy .", "fifty consecutive patients were treated for grade iii hemorrhoids from july to november @ .", "the primary outcome was postoperative pain .", "the secondary outcomes included postoperative morbidity , the resumption of social and/or working activity , patient satisfaction , and the relapse of symptoms at @ and @ months .", "no major complications occurred in either group .", "the median visual analog scale scores for pain in the hemorrhoidectomy and doppler-guided dearterialization plus mucopexy groups on days @ , @ , @ , and @ were @ vs @ , @ vs @ , @ vs @ , and @ vs @ ( p > @ ) .", "the median work resumption day was the @nd in the hemorrhoidectomy group and the @th in the doppler-guided dearterialization plus mucopexy group ( p = @ ) .", "patient satisfaction at @ and @ postoperative months , with the use of a @-point scale , was @ vs @ and @ vs @ ( p > @ ) .", "during the follow-up , @ patients in the dearterialization group required ambulatory treatment , and @ patient in each group required further surgery for symptom relapse .", "nonvalidated questionnaires were used in the follow-up .", "cost analysis was not performed .", "compared with hemorrhoidectomy , dearterialization with mucopexy resulted in similar postoperative pain and morbidity , and a similar long-term cure rate ." ]
few randomized trials have compared the results of doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy . few studies have reported long-term results . the aim of this study is to evaluate the results of doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade iii hemorrhoids . this is a prospective randomized study registered at clinicaltrials.gov ( nct@ ) . a power analysis assessed the study 's sample size . patients were randomly assigned to undergo either hemorrhoidectomy or doppler-guided hemorrhoid dearterialization plus mucopexy . the test , mann-whitney u test , student t test , and a regression model were used , as appropriate . this study was conducted at the department of surgery , san raffaele scientific institute , milan , italy . fifty consecutive patients were treated for grade iii hemorrhoids from july to november @ . the primary outcome was postoperative pain . the secondary outcomes included postoperative morbidity , the resumption of social and/or working activity , patient satisfaction , and the relapse of symptoms at @ and @ months . no major complications occurred in either group . the median visual analog scale scores for pain in the hemorrhoidectomy and doppler-guided dearterialization plus mucopexy groups on days @ , @ , @ , and @ were @ vs @ , @ vs @ , @ vs @ , and @ vs @ ( p > @ ) . the median work resumption day was the @nd in the hemorrhoidectomy group and the @th in the doppler-guided dearterialization plus mucopexy group ( p = @ ) . patient satisfaction at @ and @ postoperative months , with the use of a @-point scale , was @ vs @ and @ vs @ ( p > @ ) . during the follow-up , @ patients in the dearterialization group required ambulatory treatment , and @ patient in each group required further surgery for symptom relapse . nonvalidated questionnaires were used in the follow-up . cost analysis was not performed . compared with hemorrhoidectomy , dearterialization with mucopexy resulted in similar postoperative pain and morbidity , and a similar long-term cure rate .
24,509,458
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "management of antihistamine refractory chronic idiopathic urticaria ( ciu ) has poorly defined therapeutic options .", "to evaluate the efficacy of dapsone ( @,@ ' - diaminodiphenylsulfone ) in antihistamine refractory ciu compared with placebo .", "twenty-two patients with antihistamine refractory ciu were randomly assigned to @ mg of dapsone daily or placebo for @ weeks in a @-week double-blind , placebo-controlled crossover trial .", "end points were measured from a daily diary that reflected the weekly hive score , the weekly itch score , and a visual analog scale ( vas ) score .", "secondary to a carryover effect , the first period results were analyzed as a parallel design that compared placebo with dapsone directly by using repeated-measures analysis .", "after @ weeks , the patients in the dapsone arm showed mean improvement over baseline in vas ( @ -lsb- @ % ci , @-@ @ -rsb- , p = @ ) , urticaria score ( -@ -lsb- @ % ci , -@ to -@ -rsb- , p = @ ) , and itch score ( -@ -lsb- @ % ci , -@ to -@ -rsb- , p = @ ) , whereas the placebo arm showed no improvement over baseline for vas , urticaria , or itch scores .", "dapsone showed greater improvement compared with placebo for itch ( p = @ ) and vas ( p = @ ) .", "of the @ patients , @ showed complete resolution of hives and itch with dapsone , whereas @ % and @ % had @ % resolution of hives and itch , respectively .", "no serious adverse effects were observed with dapsone .", "to our knowledge , this is the first double-blind , placebo controlled study of dapsone in ciu and indicates that dapsone has efficacy in patients with antihistamine refractory ciu ." ]
management of antihistamine refractory chronic idiopathic urticaria ( ciu ) has poorly defined therapeutic options . to evaluate the efficacy of dapsone ( @,@ ' - diaminodiphenylsulfone ) in antihistamine refractory ciu compared with placebo . twenty-two patients with antihistamine refractory ciu were randomly assigned to @ mg of dapsone daily or placebo for @ weeks in a @-week double-blind , placebo-controlled crossover trial . end points were measured from a daily diary that reflected the weekly hive score , the weekly itch score , and a visual analog scale ( vas ) score . secondary to a carryover effect , the first period results were analyzed as a parallel design that compared placebo with dapsone directly by using repeated-measures analysis . after @ weeks , the patients in the dapsone arm showed mean improvement over baseline in vas ( @ -lsb- @ % ci , @-@ @ -rsb- , p = @ ) , urticaria score ( -@ -lsb- @ % ci , -@ to -@ -rsb- , p = @ ) , and itch score ( -@ -lsb- @ % ci , -@ to -@ -rsb- , p = @ ) , whereas the placebo arm showed no improvement over baseline for vas , urticaria , or itch scores . dapsone showed greater improvement compared with placebo for itch ( p = @ ) and vas ( p = @ ) . of the @ patients , @ showed complete resolution of hives and itch with dapsone , whereas @ % and @ % had @ % resolution of hives and itch , respectively . no serious adverse effects were observed with dapsone . to our knowledge , this is the first double-blind , placebo controlled study of dapsone in ciu and indicates that dapsone has efficacy in patients with antihistamine refractory ciu .
25,213,055
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "in alcohol-dependent patients , alcohol cues evoke increased activation in mesolimbic brain areas , such as the nucleus accumbens and the amygdala .", "moreover , patients show an alcohol approach bias , a tendency to more quickly approach than avoid alcohol cues .", "cognitive bias modification training , which aims to retrain approach biases , has been shown to reduce alcohol craving and relapse rates .", "the authors investigated effects of this training on cue reactivity in alcohol-dependent patients .", "in a double-blind randomized design , @ abstinent alcohol-dependent patients received either bias modification training or sham training .", "both trainings consisted of six sessions of the joystick approach-avoidance task ; the bias modification training entailed pushing away @ % of alcohol cues and @ % of soft drink cues , whereas this ratio was @/@ in the sham training .", "alcohol cue reactivity was measured with functional mri before and after training .", "before training , alcohol cue-evoked activation was observed in the amygdala bilaterally , as well as in the right nucleus accumbens , although here it fell short of significance .", "activation in the amygdala correlated with craving and arousal ratings of alcohol stimuli ; correlations in the nucleus accumbens again fell short of significance .", "after training , the bias modification group showed greater reductions in cue-evoked activation in the amygdala bilaterally and in behavioral arousal ratings of alcohol pictures , compared with the sham training group .", "decreases in right amygdala activity correlated with decreases in craving in the bias modification but not the sham training group .", "these findings provide evidence that cognitive bias modification affects alcohol cue-induced mesolimbic brain activity .", "reductions in neural reactivity may be a key underlying mechanism of the therapeutic effectiveness of this training ." ]
in alcohol-dependent patients , alcohol cues evoke increased activation in mesolimbic brain areas , such as the nucleus accumbens and the amygdala . moreover , patients show an alcohol approach bias , a tendency to more quickly approach than avoid alcohol cues . cognitive bias modification training , which aims to retrain approach biases , has been shown to reduce alcohol craving and relapse rates . the authors investigated effects of this training on cue reactivity in alcohol-dependent patients . in a double-blind randomized design , @ abstinent alcohol-dependent patients received either bias modification training or sham training . both trainings consisted of six sessions of the joystick approach-avoidance task ; the bias modification training entailed pushing away @ % of alcohol cues and @ % of soft drink cues , whereas this ratio was @/@ in the sham training . alcohol cue reactivity was measured with functional mri before and after training . before training , alcohol cue-evoked activation was observed in the amygdala bilaterally , as well as in the right nucleus accumbens , although here it fell short of significance . activation in the amygdala correlated with craving and arousal ratings of alcohol stimuli ; correlations in the nucleus accumbens again fell short of significance . after training , the bias modification group showed greater reductions in cue-evoked activation in the amygdala bilaterally and in behavioral arousal ratings of alcohol pictures , compared with the sham training group . decreases in right amygdala activity correlated with decreases in craving in the bias modification but not the sham training group . these findings provide evidence that cognitive bias modification affects alcohol cue-induced mesolimbic brain activity . reductions in neural reactivity may be a key underlying mechanism of the therapeutic effectiveness of this training .
25,526,597
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the effectiveness of misoprostol sublingual and oral routes before manual vacuum aspiration ( mva ) in first trimester termination of pregnancy .", "a double-blinded randomized controlled trial was conducted infirst trimester termination ofpregnancy cases .", "eighty cases were recruited and divided into sublingual and oral groups .", "both groups were randomized to receive @ microg misoprostol two hours prior to mva .", "main outcomes were cervical dilatation , operative time , complications , side effects , pain scores , and patient satisfactions .", "sublingual group had significantly more cervical dilatation and shorter operative time than oral group ( @ + / - @ vs. @ + / - @ mm , p < @ and @ + / - @ vs. @ + / - @ min , p = @ , respectively ) .", "however there were similar side effects , pain scores , and patient satisfactions in two groups .", "the present study had no uterine perforation , cervical tear hemorrhage , or re-evacuation .", "sublingual misoprostol route was more effective for cervical priming prior to mva in first trimester therapeutic abortion than oral route ." ]
to compare the effectiveness of misoprostol sublingual and oral routes before manual vacuum aspiration ( mva ) in first trimester termination of pregnancy . a double-blinded randomized controlled trial was conducted infirst trimester termination ofpregnancy cases . eighty cases were recruited and divided into sublingual and oral groups . both groups were randomized to receive @ microg misoprostol two hours prior to mva . main outcomes were cervical dilatation , operative time , complications , side effects , pain scores , and patient satisfactions . sublingual group had significantly more cervical dilatation and shorter operative time than oral group ( @ + / - @ vs. @ + / - @ mm , p < @ and @ + / - @ vs. @ + / - @ min , p = @ , respectively ) . however there were similar side effects , pain scores , and patient satisfactions in two groups . the present study had no uterine perforation , cervical tear hemorrhage , or re-evacuation . sublingual misoprostol route was more effective for cervical priming prior to mva in first trimester therapeutic abortion than oral route .
25,632,615
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the safety and efficacy of laser debulking ( ld ) and drug-eluting balloon ( deb ) angioplasty to treatment with deb angioplasty alone in patients affected by critical limb ischemia ( cli ) and superficial femoral artery ( sfa ) chronic stent occlusion in a prospective , randomized study .", "among @ cli patients treated from december @ to march @ , @ patients ( @ men ; mean age @ years ) with chronic sfa in-stent occlusion were randomly assigned to treatment using ld+deb ( n = @ ) or deb angioplasty alone ( n = @ ) .", "patency at @ months was the primary outcome measure ; secondary outcomes were target lesion revascularization ( tlr ) and clinical success at @ months .", "in the ld+deb group , the patency rates at @ and @ months ( @ % and @ % , respectively ) were significantly higher ( p = @ ) than in the deb only patients ( @ % and @ % , respectively ) .", "tlr at @ months was @ % in the ld+deb group and @ % in the deb only group ( p = @ ) .", "two ( @ % ) patients needed major amputations in the ld+deb group vs. @ ( @ % ) in the deb only group at @ months ( p = @ ) .", "in this small initial experience , combined treatment with ld and deb angioplasty is correlated with better outcomes in cli patients with occluded sfa stents ." ]
to compare the safety and efficacy of laser debulking ( ld ) and drug-eluting balloon ( deb ) angioplasty to treatment with deb angioplasty alone in patients affected by critical limb ischemia ( cli ) and superficial femoral artery ( sfa ) chronic stent occlusion in a prospective , randomized study . among @ cli patients treated from december @ to march @ , @ patients ( @ men ; mean age @ years ) with chronic sfa in-stent occlusion were randomly assigned to treatment using ld+deb ( n = @ ) or deb angioplasty alone ( n = @ ) . patency at @ months was the primary outcome measure ; secondary outcomes were target lesion revascularization ( tlr ) and clinical success at @ months . in the ld+deb group , the patency rates at @ and @ months ( @ % and @ % , respectively ) were significantly higher ( p = @ ) than in the deb only patients ( @ % and @ % , respectively ) . tlr at @ months was @ % in the ld+deb group and @ % in the deb only group ( p = @ ) . two ( @ % ) patients needed major amputations in the ld+deb group vs. @ ( @ % ) in the deb only group at @ months ( p = @ ) . in this small initial experience , combined treatment with ld and deb angioplasty is correlated with better outcomes in cli patients with occluded sfa stents .
24,325,697
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "hypertension is one of the most common co-existing conditions in patients with chronic pain , and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension .", "the purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release ( er ) treatment in patients with hypertension .", "we performed a post hoc analysis of data pooled from three randomized , placebo - and active-controlled , phase iii studies of tapentadol er for managing chronic osteoarthritis knee ( nct@ , nct@ ) or low back ( nct@ ) pain ( @-week , double-blind treatment period ) .", "data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline .", "heart rate , systolic blood pressure ( sbp ) , and diastolic blood pressure ( dbp ) were measured at each visit .", "in patients with a listed medical history of hypertension ( n = @,@ ) , least-squares mean ( lsm -lsb- standard error ( se ) -rsb- ) changes from baseline to endpoint with placebo , tapentadol er , and oxycodone hcl controlled release ( cr ) , respectively , were -@ ( @ ) , @ ( @ ) , and -@ ( @ ) beats per minute ( bpm ) for heart rate ; -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for sbp ; and -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for dbp ; in patients with at least one listed concomitant antihypertensive medication ( n = @,@ ) , the lsm ( se ) changes from baseline to endpoint were -@ ( @ ) , @ ( @ ) , and -@ ( @ ) bpm for heart rate ; -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for sbp ; and -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for dbp .", "no clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol er ( @-@ mg twice daily ) ." ]
hypertension is one of the most common co-existing conditions in patients with chronic pain , and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension . the purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release ( er ) treatment in patients with hypertension . we performed a post hoc analysis of data pooled from three randomized , placebo - and active-controlled , phase iii studies of tapentadol er for managing chronic osteoarthritis knee ( nct@ , nct@ ) or low back ( nct@ ) pain ( @-week , double-blind treatment period ) . data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline . heart rate , systolic blood pressure ( sbp ) , and diastolic blood pressure ( dbp ) were measured at each visit . in patients with a listed medical history of hypertension ( n = @,@ ) , least-squares mean ( lsm -lsb- standard error ( se ) -rsb- ) changes from baseline to endpoint with placebo , tapentadol er , and oxycodone hcl controlled release ( cr ) , respectively , were -@ ( @ ) , @ ( @ ) , and -@ ( @ ) beats per minute ( bpm ) for heart rate ; -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for sbp ; and -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for dbp ; in patients with at least one listed concomitant antihypertensive medication ( n = @,@ ) , the lsm ( se ) changes from baseline to endpoint were -@ ( @ ) , @ ( @ ) , and -@ ( @ ) bpm for heart rate ; -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for sbp ; and -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) mmhg for dbp . no clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol er ( @-@ mg twice daily ) .
24,916,058
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "to assess the relative bioavailability of a new subcutaneous ( sc ) diclofenac hydroxypropyl b-cyclodextrin ( hpbcd ) formulation administered to three body sites : quadriceps , gluteus , and abdomen .", "this was a pilot , single-dose , randomized , three-way crossover relative bioavailability study .", "a total of @ healthy subjects received a single sc injection of diclofenac hpbcd @ mg/@ ml in the quadriceps , gluteus , or abdomen .", "the auc was comparable after sc diclofenac hpbcd in the quadriceps , gluteus , and abdomen .", "the cmax was comparable after sc administration in the quadriceps or abdomen , and ~ @ % higher in the gluteus .", "the absorption was rapid ( @ minutes ) after administration of the treatment at any site .", "the treatment was well tolerated .", "the relative bioavailability of sc diclofenac hpbcd was comparable when administered to the quadriceps , gluteus , and abdomen .", "the new diclofenac formulation can therefore be administered subcutaneously to any of these sites without clinically significant differences .", "a further adequately powered study would be necessary to reveal any differences among injection sites in terms of peak plasma concentration ." ]
to assess the relative bioavailability of a new subcutaneous ( sc ) diclofenac hydroxypropyl b-cyclodextrin ( hpbcd ) formulation administered to three body sites : quadriceps , gluteus , and abdomen . this was a pilot , single-dose , randomized , three-way crossover relative bioavailability study . a total of @ healthy subjects received a single sc injection of diclofenac hpbcd @ mg/@ ml in the quadriceps , gluteus , or abdomen . the auc was comparable after sc diclofenac hpbcd in the quadriceps , gluteus , and abdomen . the cmax was comparable after sc administration in the quadriceps or abdomen , and ~ @ % higher in the gluteus . the absorption was rapid ( @ minutes ) after administration of the treatment at any site . the treatment was well tolerated . the relative bioavailability of sc diclofenac hpbcd was comparable when administered to the quadriceps , gluteus , and abdomen . the new diclofenac formulation can therefore be administered subcutaneously to any of these sites without clinically significant differences . a further adequately powered study would be necessary to reveal any differences among injection sites in terms of peak plasma concentration .
24,361,086
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the correlation between the dosage frequency of sildenafil and its treatment outcomes in men with erectile dysfunction ( ed ) .", "data were from a @-week , multicenter , observational study of men ( @ ) , between @ and @ years of age , with a clinical diagnosis of ed defined as the sexual health inventory for men ( shim ) score @ .", "the erectile function and quality of sexual life were evaluated at the baseline and the endpoint of sildenafil treatment ( after @ weeks ) by using shim , self-esteem and relationship questionnaire , @-item short form health survey , erection hardness score , and the global efficacy question .", "nine hundred thirty-five patients were enrolled in the @ weekly , @ in the @-@ weekly , and @ in the @-@ weekly dosage frequency cohorts .", "after @ weeks of treatment , a higher dosage frequency of sildenafil was associated with a better shim , self-esteem and relationship questionnaire , and @-item short form health survey score improvement ( all p < @ ) .", "hyperlipidemia is a poor prognostic factor ( odds ratio , @ ; p = @ ) , whereas hypertension ( odds ratio , @ ; p < @ ) and coronary heart disease ( odds ratio , @ ; p = @ ) are sensitive to sildenafil treatment .", "higher dosage frequency of sildenafil is associated with a better improvement of sexual function and quality of life of men with ed , and the concomitant treatment of hyperlipidemia is recommended ." ]
to evaluate the correlation between the dosage frequency of sildenafil and its treatment outcomes in men with erectile dysfunction ( ed ) . data were from a @-week , multicenter , observational study of men ( @ ) , between @ and @ years of age , with a clinical diagnosis of ed defined as the sexual health inventory for men ( shim ) score @ . the erectile function and quality of sexual life were evaluated at the baseline and the endpoint of sildenafil treatment ( after @ weeks ) by using shim , self-esteem and relationship questionnaire , @-item short form health survey , erection hardness score , and the global efficacy question . nine hundred thirty-five patients were enrolled in the @ weekly , @ in the @-@ weekly , and @ in the @-@ weekly dosage frequency cohorts . after @ weeks of treatment , a higher dosage frequency of sildenafil was associated with a better shim , self-esteem and relationship questionnaire , and @-item short form health survey score improvement ( all p < @ ) . hyperlipidemia is a poor prognostic factor ( odds ratio , @ ; p = @ ) , whereas hypertension ( odds ratio , @ ; p < @ ) and coronary heart disease ( odds ratio , @ ; p = @ ) are sensitive to sildenafil treatment . higher dosage frequency of sildenafil is associated with a better improvement of sexual function and quality of life of men with ed , and the concomitant treatment of hyperlipidemia is recommended .
26,142,584
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "ligasure , a bipolar electronic vessel sealing system , has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer .", "in this multicenter , prospective , randomized controlled trial , patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with ligasure or a conventional technique .", "of the @ patients enrolled , @ were randomized to the ligasure group and @ to the conventional group .", "patient characteristics were well balanced in the two groups .", "there were no significant differences between the ligasure and conventional groups in blood loss ( @ vs. @ml , respectively ; p = @ ) or operative time ( @ and @min , respectively ; p = @ ) ; nor in the incidence of surgical complications or duration of postoperative hospital stay .", "in a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum , the use of ligasure significantly reduced blood loss ( @ vs. @ml ; p = @ ) , and the duration of the operation ( @ vs. @min ; p = @ ) .", "ligasure did not contribute to reducing intraoperative blood loss , operative time , or other adverse surgical outcomes .", "the usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy ." ]
ligasure , a bipolar electronic vessel sealing system , has become popular in abdominal surgery but few clinical studies have been conducted to evaluate its effectiveness in radical gastrectomy for gastric cancer . in this multicenter , prospective , randomized controlled trial , patients with curative gastric cancer were randomly assigned to undergo gastrectomy either with ligasure or a conventional technique . of the @ patients enrolled , @ were randomized to the ligasure group and @ to the conventional group . patient characteristics were well balanced in the two groups . there were no significant differences between the ligasure and conventional groups in blood loss ( @ vs. @ml , respectively ; p = @ ) or operative time ( @ and @min , respectively ; p = @ ) ; nor in the incidence of surgical complications or duration of postoperative hospital stay . in a subgroup analysis of patients who underwent gastrectomy that preserved the distal part of the greater omentum , the use of ligasure significantly reduced blood loss ( @ vs. @ml ; p = @ ) , and the duration of the operation ( @ vs. @min ; p = @ ) . ligasure did not contribute to reducing intraoperative blood loss , operative time , or other adverse surgical outcomes . the usefulness of the device may be limited to a specific part of the surgical procedure in open gastrectomy .
24,838,660
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cerebral microbleeds have been observed in normal-appearing brain tissue of patients with glioma years after receiving radiation therapy .", "the contrast of these paramagnetic lesions varies with field strength due to differences in the effects of susceptibility .", "the purpose of this study was to compare @t and @t mri as platforms for detecting cerebral microbleeds in patients treated with radiotherapy using susceptibility-weighted imaging ( swi ) .", "swi was performed with both @t and @t mr scanners on ten patients with glioma who had received prior radiotherapy .", "imaging sequences were optimized to obtain data within a clinically acceptable scan time .", "both t@ * - weighted magnitude images and swi data were reconstructed , minimum intensity projection was implemented , and microbleeds were manually identified .", "the number of microbleeds was counted and compared among datasets .", "significantly more microbleeds were identified on swi than magnitude images at both @t ( p = @ ) and @t ( p = @ ) .", "seven-tesla swi detected significantly more microbleeds than @t swi for seven out of ten patients who had tumors located remote from deep brain regions ( p = @ ) , but when the additional three patients with more inferior tumors were included , the difference was not significant .", "swi is more sensitive for detecting microbleeds than magnitude images at both @t and @t .", "for areas without heightened susceptibility artifacts , @t swi is more sensitive to detecting radiation therapy-induced microbleeds than @t swi .", "tumor location should be considered in conjunction with field strength when selecting the most appropriate strategy for imaging microbleeds ." ]
cerebral microbleeds have been observed in normal-appearing brain tissue of patients with glioma years after receiving radiation therapy . the contrast of these paramagnetic lesions varies with field strength due to differences in the effects of susceptibility . the purpose of this study was to compare @t and @t mri as platforms for detecting cerebral microbleeds in patients treated with radiotherapy using susceptibility-weighted imaging ( swi ) . swi was performed with both @t and @t mr scanners on ten patients with glioma who had received prior radiotherapy . imaging sequences were optimized to obtain data within a clinically acceptable scan time . both t@ * - weighted magnitude images and swi data were reconstructed , minimum intensity projection was implemented , and microbleeds were manually identified . the number of microbleeds was counted and compared among datasets . significantly more microbleeds were identified on swi than magnitude images at both @t ( p = @ ) and @t ( p = @ ) . seven-tesla swi detected significantly more microbleeds than @t swi for seven out of ten patients who had tumors located remote from deep brain regions ( p = @ ) , but when the additional three patients with more inferior tumors were included , the difference was not significant . swi is more sensitive for detecting microbleeds than magnitude images at both @t and @t . for areas without heightened susceptibility artifacts , @t swi is more sensitive to detecting radiation therapy-induced microbleeds than @t swi . tumor location should be considered in conjunction with field strength when selecting the most appropriate strategy for imaging microbleeds .
24,281,386
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess the microflora of root canals in primary molars following use of rotary niti files and conventional hand niti and stainless steel files .", "this randomized clinical trial consisted of a total of @ first and second primary molars requiring root canal treatment , who were selected from children aged @-@ years .", "based on type of root canal instrumentation , the teeth were randomly assigned to three groups of twenty teeth each ; group a : rotary niti files , group b : hand niti files and group c : hand stainless steel files .", "following administration of local anesthesia , isolation with rubber dam was carried out .", "for the purpose of instrumentation and sampling , the palatal canal of maxillary molars and the distal canal of mandibular molars were selected .", "prior to sampling , the orifices of other canals in these teeth were sealed , so as to prevent any contamination .", "instrumentation was carried out in each group using respective instruments along with intermittent saline irrigation .", "root canal samples were obtained both before and after instrumentation , using sterile absorbent paper points and transferred to a sterile vial with transport fluid .", "serial dilutions were prepared and cultured on suitable agar media .", "both aerobic and anaerobic microbial counts were made .", "data obtained was subjected to statistical analysis using wilcoxon signed rank test and one-way analysis of variance .", "in all three groups , there was a significant reduction in both aerobic and anaerobic mean microbial count following root canal instrumentation .", "( p < @ ) .", "rotary niti files were as efficient as conventional hand instruments in significantly reducing the root canal microflora ." ]
to assess the microflora of root canals in primary molars following use of rotary niti files and conventional hand niti and stainless steel files . this randomized clinical trial consisted of a total of @ first and second primary molars requiring root canal treatment , who were selected from children aged @-@ years . based on type of root canal instrumentation , the teeth were randomly assigned to three groups of twenty teeth each ; group a : rotary niti files , group b : hand niti files and group c : hand stainless steel files . following administration of local anesthesia , isolation with rubber dam was carried out . for the purpose of instrumentation and sampling , the palatal canal of maxillary molars and the distal canal of mandibular molars were selected . prior to sampling , the orifices of other canals in these teeth were sealed , so as to prevent any contamination . instrumentation was carried out in each group using respective instruments along with intermittent saline irrigation . root canal samples were obtained both before and after instrumentation , using sterile absorbent paper points and transferred to a sterile vial with transport fluid . serial dilutions were prepared and cultured on suitable agar media . both aerobic and anaerobic microbial counts were made . data obtained was subjected to statistical analysis using wilcoxon signed rank test and one-way analysis of variance . in all three groups , there was a significant reduction in both aerobic and anaerobic mean microbial count following root canal instrumentation . ( p < @ ) . rotary niti files were as efficient as conventional hand instruments in significantly reducing the root canal microflora .
24,683,774
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "disruptive behavior is common in children with autism spectrum disorder .", "behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale randomized trials .", "to evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior .", "this @-week randomized trial compared parent training ( n = @ ) to parent education ( n = @ ) at @ centers ( emory university , indiana university , ohio state university , university of pittsburgh , university of rochester , yale university ) .", "we screened @ children ; @ children ( aged @-@ years ) with autism spectrum disorder and disruptive behaviors were randomly assigned ( @ % white , @ % male ) between september @ and february @ .", "parent training ( @ core , @ optional sessions ; @ telephone boosters ; @ home visits ) provided specific strategies to manage disruptive behavior .", "parent education ( @ core sessions , @ home visit ) provided information about autism but no behavior management strategies .", "parents rated disruptive behavior and noncompliance on co-primary outcomes : the aberrant behavior checklist-irritability subscale ( range , @-@ ) and the home situations questionnaire-autism spectrum disorder ( range , @-@ ) .", "on both measures , higher scores indicate greater severity and a @ % reduction indicates clinical improvement .", "a clinician blind to treatment assignment rated the improvement scale of the clinical global impression ( range , @-@ ) , a secondary outcome , with a positive response less than @ .", "at week @ , the aberrant behavior checklist-irritability subscale declined @ % in parent training ( from @ to @ ) compared with @ % for parent education ( @ to @ ) ( treatment effect , -@ ; @ % ci , -@ to -@ ; p < @ , standardized effect size = @ ) .", "the home situations questionnaire-autism spectrum disorder declined @ % ( from @ to @ ) compared with @ % in parent education ( @ to @ ) ( treatment effect , -@ ; @ % ci , -@ to -@ ; p < @ , standardized effect size = @ ) .", "neither measure met the prespecified minimal clinically important difference .", "the proportions with a positive response on the clinical global impression-improvement scale were @ % for parent training vs @ % for parent education ( p < @ ) .", "for children with autism spectrum disorder , a @-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear .", "the rate of positive response judged by a blinded clinician was greater for parent training vs parent education .", "clinicaltrials.gov identifier : nct@ ." ]
disruptive behavior is common in children with autism spectrum disorder . behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale randomized trials . to evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior . this @-week randomized trial compared parent training ( n = @ ) to parent education ( n = @ ) at @ centers ( emory university , indiana university , ohio state university , university of pittsburgh , university of rochester , yale university ) . we screened @ children ; @ children ( aged @-@ years ) with autism spectrum disorder and disruptive behaviors were randomly assigned ( @ % white , @ % male ) between september @ and february @ . parent training ( @ core , @ optional sessions ; @ telephone boosters ; @ home visits ) provided specific strategies to manage disruptive behavior . parent education ( @ core sessions , @ home visit ) provided information about autism but no behavior management strategies . parents rated disruptive behavior and noncompliance on co-primary outcomes : the aberrant behavior checklist-irritability subscale ( range , @-@ ) and the home situations questionnaire-autism spectrum disorder ( range , @-@ ) . on both measures , higher scores indicate greater severity and a @ % reduction indicates clinical improvement . a clinician blind to treatment assignment rated the improvement scale of the clinical global impression ( range , @-@ ) , a secondary outcome , with a positive response less than @ . at week @ , the aberrant behavior checklist-irritability subscale declined @ % in parent training ( from @ to @ ) compared with @ % for parent education ( @ to @ ) ( treatment effect , -@ ; @ % ci , -@ to -@ ; p < @ , standardized effect size = @ ) . the home situations questionnaire-autism spectrum disorder declined @ % ( from @ to @ ) compared with @ % in parent education ( @ to @ ) ( treatment effect , -@ ; @ % ci , -@ to -@ ; p < @ , standardized effect size = @ ) . neither measure met the prespecified minimal clinically important difference . the proportions with a positive response on the clinical global impression-improvement scale were @ % for parent training vs @ % for parent education ( p < @ ) . for children with autism spectrum disorder , a @-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear . the rate of positive response judged by a blinded clinician was greater for parent training vs parent education . clinicaltrials.gov identifier : nct@ .
25,898,050
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "as relapse after completed cognitive behavior therapy ( cbt ) for obsessive-compulsive disorder ( ocd ) is common , many treatment protocols include booster programs to improve the long-term effects .", "however , the effects of booster programs are not well studied .", "in this study , we investigated the long-term efficacy of internet-based cbt ( icbt ) with therapist support for ocd with or without an internet-based booster program .", "a total of @ participants were included in the long-term follow-up analysis of icbt .", "of these , @ were randomized to a booster program or no booster program .", "outcome assessments were collected at @ , @ , @ and @ months after receiving icbt .", "the entire sample had sustained long-term effects from pre-treatment to all follow-up assessments , with large within-group effect sizes ( cohen 's d = @-@ @ ) .", "the booster group had a significant mean reduction in ocd symptoms compared to the control condition from booster baseline ( @ months ) to @ months , but not at @ or @ months .", "participants in the booster group improved significantly in terms of general functioning at @ , @ and @ months , and had fewer relapses .", "kaplan-meier analysis also indicated a significantly slower relapse rate in the booster group .", "the results suggest that icbt has sustained long-term effects and that adding an internet-based booster program can further improve long-term outcome and prevent relapse for some ocd patients ." ]
as relapse after completed cognitive behavior therapy ( cbt ) for obsessive-compulsive disorder ( ocd ) is common , many treatment protocols include booster programs to improve the long-term effects . however , the effects of booster programs are not well studied . in this study , we investigated the long-term efficacy of internet-based cbt ( icbt ) with therapist support for ocd with or without an internet-based booster program . a total of @ participants were included in the long-term follow-up analysis of icbt . of these , @ were randomized to a booster program or no booster program . outcome assessments were collected at @ , @ , @ and @ months after receiving icbt . the entire sample had sustained long-term effects from pre-treatment to all follow-up assessments , with large within-group effect sizes ( cohen 's d = @-@ @ ) . the booster group had a significant mean reduction in ocd symptoms compared to the control condition from booster baseline ( @ months ) to @ months , but not at @ or @ months . participants in the booster group improved significantly in terms of general functioning at @ , @ and @ months , and had fewer relapses . kaplan-meier analysis also indicated a significantly slower relapse rate in the booster group . the results suggest that icbt has sustained long-term effects and that adding an internet-based booster program can further improve long-term outcome and prevent relapse for some ocd patients .
25,066,102
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "data from an open label randomised controlled trial have suggested possible advantages on both motor and non-motor measures in patients with parkinson 's disease following @ months exposure to exenatide .", "continued follow up of these same patients was performed to investigate whether these possible advantages persisted in the prolonged absence of this medication .", "all participants from an open label , randomised controlled trial of exenatide as a treatment for parkinson 's disease , were invited for a further follow up assessment at the ucl institute of neurology .", "this visit included all @ individuals who had previously completed twelve months exposure to exenatide @ug bd and the @ individuals who had acted as randomised controls .", "motor severity of pd was compared after overnight withdrawal of conventional pd medication using blinded video assessment of the mds-updrs , together with several non-motor tests .", "this assessment was thus @ months after their original baseline visit , i.e. @ months after cessation of exenatide .", "compared to the control group of patients , patients previously exposed to exenatide had an advantage of @ points ( @ % ci , @-@ @ ; p = @ ) using blinded video rating of the mds-updrs part @ motor subscale .", "there was also a difference of @ points ; ( @ % ci , @-@ @ ; p = @ ) between the @ groups on the mattis dementia rating scale .", "while these data must still not be interpreted as evidence of neuroprotection , they nevertheless provide strong encouragement for the further study of this drug as a potential disease modifying agent in parkinson 's disease ." ]
data from an open label randomised controlled trial have suggested possible advantages on both motor and non-motor measures in patients with parkinson 's disease following @ months exposure to exenatide . continued follow up of these same patients was performed to investigate whether these possible advantages persisted in the prolonged absence of this medication . all participants from an open label , randomised controlled trial of exenatide as a treatment for parkinson 's disease , were invited for a further follow up assessment at the ucl institute of neurology . this visit included all @ individuals who had previously completed twelve months exposure to exenatide @ug bd and the @ individuals who had acted as randomised controls . motor severity of pd was compared after overnight withdrawal of conventional pd medication using blinded video assessment of the mds-updrs , together with several non-motor tests . this assessment was thus @ months after their original baseline visit , i.e. @ months after cessation of exenatide . compared to the control group of patients , patients previously exposed to exenatide had an advantage of @ points ( @ % ci , @-@ @ ; p = @ ) using blinded video rating of the mds-updrs part @ motor subscale . there was also a difference of @ points ; ( @ % ci , @-@ @ ; p = @ ) between the @ groups on the mattis dementia rating scale . while these data must still not be interpreted as evidence of neuroprotection , they nevertheless provide strong encouragement for the further study of this drug as a potential disease modifying agent in parkinson 's disease .
24,662,192
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the medical antiarrhythmic treatment or radiofrequency ablation in paroxysmal atrial fibrillation ( mantra-paf ) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation ( rfa ) vs. antiarrhythmic drug therapy ( aad ) as first-line treatment for patients with paf .", "in this substudy , we evaluated the effect of these treatment modalities on the health-related quality of life ( hrqol ) and symptom burden of patients at @ and @ months .", "during the study period , @ patients were enrolled in the mantra-paf trial and randomized to receive aad ( n = @ ) or rfa ( n = @ ) .", "two generic questionnaires were used to assess the hrqol -lsb- short form-@ ( sf-@ ) and euroqol-five dimensions ( eq-@d ) -rsb- , and the arrhythmia-specific questionnaire in tachycardia and arrhythmia ( asta ) was used to evaluate the symptoms appearing during the trial .", "all comparisons were made on an intention-to-treat basis .", "both randomization groups showed significant improvements in assessments with both sf-@ and eq-@d , at @ months .", "patients randomized to rfa showed significantly greater improvement in four physically related scales of the sf-@ .", "the three most frequently reported symptoms were breathlessness during activity , pronounced tiredness , and worry/anxiety .", "in both groups , there was a significant reduction in asta symptom index and in the severity of seven of the eight symptoms over time .", "both aad and rfa as first-line treatment resulted in substantial improvement of hrqol and symptom burden in patients with paf .", "patients randomized to rfa showed greater improvement in physical scales ( sf-@ ) and the eq-visual analogue scale .", "url http://www.clinicaltrials.gov .", "unique identifier : nct@ ." ]
the medical antiarrhythmic treatment or radiofrequency ablation in paroxysmal atrial fibrillation ( mantra-paf ) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation ( rfa ) vs. antiarrhythmic drug therapy ( aad ) as first-line treatment for patients with paf . in this substudy , we evaluated the effect of these treatment modalities on the health-related quality of life ( hrqol ) and symptom burden of patients at @ and @ months . during the study period , @ patients were enrolled in the mantra-paf trial and randomized to receive aad ( n = @ ) or rfa ( n = @ ) . two generic questionnaires were used to assess the hrqol -lsb- short form-@ ( sf-@ ) and euroqol-five dimensions ( eq-@d ) -rsb- , and the arrhythmia-specific questionnaire in tachycardia and arrhythmia ( asta ) was used to evaluate the symptoms appearing during the trial . all comparisons were made on an intention-to-treat basis . both randomization groups showed significant improvements in assessments with both sf-@ and eq-@d , at @ months . patients randomized to rfa showed significantly greater improvement in four physically related scales of the sf-@ . the three most frequently reported symptoms were breathlessness during activity , pronounced tiredness , and worry/anxiety . in both groups , there was a significant reduction in asta symptom index and in the severity of seven of the eight symptoms over time . both aad and rfa as first-line treatment resulted in substantial improvement of hrqol and symptom burden in patients with paf . patients randomized to rfa showed greater improvement in physical scales ( sf-@ ) and the eq-visual analogue scale . url http://www.clinicaltrials.gov . unique identifier : nct@ .
25,567,068
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "to establish the efficiency of bowel ligatures in colon cancer surgery , focusing on the extent to which exfoliated cancer cells are shed in the colonic lumen during sigmoidectomy .", "twenty consecutive patients who underwent sigmoidectomy for sigmoid colon cancer were prospectively randomized into two groups : the `` ligatures group '' , in which bowel ligatures were placed , @ , @ , @ cm from the tumor proximally and distally before dissection ; and the `` no ligatures group '' , in which the corresponding sites were ligated only immediately before taking the specimen out .", "each colonic segment ligated was irrigated with saline and samples were sent for blind cytological examination .", "cancer cells were found in the colonic segment where the tumor was located , in @ of @ samples .", "the frequency of free cancer cells decreased from @ to @ % ( p < @ ) in the distal @-@ cm colonic segment and from @ to @ % ( p < @ ) in the proximal colonic segment after performing bowel ligatures .", "free cancer cells were confirmed in @ of @ samples at both colonic segments @-@ cm from the tumor , even after bowel ligatures .", "intraluminal exfoliated cancer cells could be eliminated by placing bowel ligatures during sigmoidectomy .", "measures should be considered to eliminate exfoliated cancer cells during colectomy , even after placing bowel ligatures ." ]
to establish the efficiency of bowel ligatures in colon cancer surgery , focusing on the extent to which exfoliated cancer cells are shed in the colonic lumen during sigmoidectomy . twenty consecutive patients who underwent sigmoidectomy for sigmoid colon cancer were prospectively randomized into two groups : the `` ligatures group '' , in which bowel ligatures were placed , @ , @ , @ cm from the tumor proximally and distally before dissection ; and the `` no ligatures group '' , in which the corresponding sites were ligated only immediately before taking the specimen out . each colonic segment ligated was irrigated with saline and samples were sent for blind cytological examination . cancer cells were found in the colonic segment where the tumor was located , in @ of @ samples . the frequency of free cancer cells decreased from @ to @ % ( p < @ ) in the distal @-@ cm colonic segment and from @ to @ % ( p < @ ) in the proximal colonic segment after performing bowel ligatures . free cancer cells were confirmed in @ of @ samples at both colonic segments @-@ cm from the tumor , even after bowel ligatures . intraluminal exfoliated cancer cells could be eliminated by placing bowel ligatures during sigmoidectomy . measures should be considered to eliminate exfoliated cancer cells during colectomy , even after placing bowel ligatures .
24,318,457
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the at lisa @m ( carl zeiss meditec , jena , germany ) versus the acrysof restor sn@ad@ ( alcon laboratories , irvine , ca ) multifocal intraocular lens ( iol ) .", "double-masked , prospective , randomized , controlled clinical trial .", "a total of @ patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange .", "patients were preoperatively randomized ( allocation ratio @:@ ) to bilateral implantation with the at lisa @m iol or restor sn@ad@ iol .", "postoperative outcomes were assessed @ to @ months after second eye surgery .", "the primary outcome was visual symptoms evaluated with the quality of vision ( qov ) questionnaire .", "secondary outcomes included other questionnaire data ( catquest-@sf , spectacle independence , vision satisfaction , and dysphotopsia ) and visual function measures ( near , intermediate , and distance visual acuity , binocular reading speed -lsb- international reading speed texts -rsb- , contrast sensitivity , and forward light scatter ) .", "adverse events , including intraoperative and postoperative complications , also were evaluated .", "there was no significant difference between iol groups in rasch-adjusted qov scores for frequency ( p = @ ) , severity ( p = @ ) , and bothersomeness ( p = @ ) of visual symptoms ; median ( interquartile ) scores for these qov subscales were @ ( @-@ ) , @ ( @-@ ) , and @ ( @-@ ) for the at lisa @m iol group , respectively , and @ ( @-@ ) , @ ( @-@ ) , and @ ( @-@ ) for the restor sn@ad@ iol group , respectively .", "halo was the most prominent dysphotopsia symptom , with @ % in both iol groups reporting halo symptoms as very bothersome .", "complete spectacle independence was achieved in @ of @ ( @ % ) at lisa @m recipients and @ of @ ( @ % ) restor sn@ad@ recipients ( p = @ ) .", "preferred reading distance was slightly nearer for the at lisa @m iol .", "there were no statistically significant differences in any of the other secondary outcome measures .", "visual symptoms were similar after bilateral implantation of the at lisa @m and restor sn@ad@ iols .", "both these diffractive bifocal iols produce high levels of spectacle independence and patient satisfaction .", "however , a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results @ to @ months after surgery ." ]
to compare postoperative visual symptoms and spectacle freedom after bilateral implantation of the at lisa @m ( carl zeiss meditec , jena , germany ) versus the acrysof restor sn@ad@ ( alcon laboratories , irvine , ca ) multifocal intraocular lens ( iol ) . double-masked , prospective , randomized , controlled clinical trial . a total of @ patients undergoing bilateral sequential cataract surgery or bilateral refractive lens exchange . patients were preoperatively randomized ( allocation ratio @:@ ) to bilateral implantation with the at lisa @m iol or restor sn@ad@ iol . postoperative outcomes were assessed @ to @ months after second eye surgery . the primary outcome was visual symptoms evaluated with the quality of vision ( qov ) questionnaire . secondary outcomes included other questionnaire data ( catquest-@sf , spectacle independence , vision satisfaction , and dysphotopsia ) and visual function measures ( near , intermediate , and distance visual acuity , binocular reading speed -lsb- international reading speed texts -rsb- , contrast sensitivity , and forward light scatter ) . adverse events , including intraoperative and postoperative complications , also were evaluated . there was no significant difference between iol groups in rasch-adjusted qov scores for frequency ( p = @ ) , severity ( p = @ ) , and bothersomeness ( p = @ ) of visual symptoms ; median ( interquartile ) scores for these qov subscales were @ ( @-@ ) , @ ( @-@ ) , and @ ( @-@ ) for the at lisa @m iol group , respectively , and @ ( @-@ ) , @ ( @-@ ) , and @ ( @-@ ) for the restor sn@ad@ iol group , respectively . halo was the most prominent dysphotopsia symptom , with @ % in both iol groups reporting halo symptoms as very bothersome . complete spectacle independence was achieved in @ of @ ( @ % ) at lisa @m recipients and @ of @ ( @ % ) restor sn@ad@ recipients ( p = @ ) . preferred reading distance was slightly nearer for the at lisa @m iol . there were no statistically significant differences in any of the other secondary outcome measures . visual symptoms were similar after bilateral implantation of the at lisa @m and restor sn@ad@ iols . both these diffractive bifocal iols produce high levels of spectacle independence and patient satisfaction . however , a small but clinically significant minority of patients remained symptomatic and dissatisfied with visual results @ to @ months after surgery .
25,537,197
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "little is known about how colorectal cancer screening test preferences operate together with test access and navigation to influence screening adherence in primary care .", "we analyzed data from a randomized trial of @ primary care patients to assess the independent effects of screening test preference for fecal immunochemical test ( fit ) or colonoscopy , mailed access to fit and colonoscopy , and telephone navigation for fit and colonoscopy , on screening .", "preference was not associated with overall screening , but individuals who preferred fit were more likely to complete fit screening ( p = @ ) , whereas those who preferred colonoscopy were more likely to perform colonoscopy screening ( p = @ ) .", "mailed access to fit and colonoscopy was associated with increased overall screening ( or = @ , p = @ ) , due to a @-fold increase in fit use .", "telephone navigation was also associated with increased overall screening ( or = @ , p = @ ) , mainly due to a @-fold increase in colonoscopy performance .", "we estimated that providing access and navigation for both screening tests may substantially increase screening compared with a preference-tailored approach , mainly due to increased performance of nonpreferred tests .", "preference influences the type of screening tests completed .", "test access increases fit and navigation mainly increases colonoscopy .", "screening strategies providing access and navigation to both tests may be more effective than preference-tailored approaches .", "preference tailoring in colorectal cancer screening strategies should be avoided if the objective is to maximize screening rates , although other factors ( e.g. , costs , necessary follow-up ) should also be considered ." ]
little is known about how colorectal cancer screening test preferences operate together with test access and navigation to influence screening adherence in primary care . we analyzed data from a randomized trial of @ primary care patients to assess the independent effects of screening test preference for fecal immunochemical test ( fit ) or colonoscopy , mailed access to fit and colonoscopy , and telephone navigation for fit and colonoscopy , on screening . preference was not associated with overall screening , but individuals who preferred fit were more likely to complete fit screening ( p = @ ) , whereas those who preferred colonoscopy were more likely to perform colonoscopy screening ( p = @ ) . mailed access to fit and colonoscopy was associated with increased overall screening ( or = @ , p = @ ) , due to a @-fold increase in fit use . telephone navigation was also associated with increased overall screening ( or = @ , p = @ ) , mainly due to a @-fold increase in colonoscopy performance . we estimated that providing access and navigation for both screening tests may substantially increase screening compared with a preference-tailored approach , mainly due to increased performance of nonpreferred tests . preference influences the type of screening tests completed . test access increases fit and navigation mainly increases colonoscopy . screening strategies providing access and navigation to both tests may be more effective than preference-tailored approaches . preference tailoring in colorectal cancer screening strategies should be avoided if the objective is to maximize screening rates , although other factors ( e.g. , costs , necessary follow-up ) should also be considered .
24,813,819
[ "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "appropriate sedation benefits patients by reducing the stress response , but it requires an appropriate method of assessment to adjust the dosage of sedatives .", "the aim of this study was to compare the difference in the sedation of mechanically ventilated patients undergoing flexible bronchoscopy ( fb ) monitored by auditory-evoked potentials ( aeps ) or the ramsay sedation scale ( rss ) .", "in a prospective , randomized , controlled study , all patients who underwent fb with propofol sedation were monitored and their sedation adjusted .", "during fb , one group was monitored by aep and another group was monitored by rss .", "the propofol dosage was adjusted by the nursing staff during examination to maintain the alaris aep index ( aai ) value between @ and @ in the aep group and the rss at @ or @ in the rss group .", "before fb and during fb , the aai , heart rate ( hr ) , and mean arterial pressure ( map ) were recorded every @ min .", "the percentages of time at the sedation target and the propofol dosages were calculated .", "nineteen patients received aep monitoring and @ patients received rss monitoring .", "the percentage of time at the sedation target during fb was significantly higher in the aep monitoring group ( @ % ; interquartile range -lsb- iqr -rsb- , @-@ @ % ) than in the rss group ( @ % ; iqr , @-@ @ % ) , ( p < @ ) .", "during fb , the rss group had a significantly higher aai ( p = @ ) , hr ( p < @ ) , and map ( p < @ ) than the aep group .", "in mechanically ventilated patients undergoing fb , aep monitoring resulted in less variation in aai , hr , and map , and a higher percentage of time at the sedation target than rss monitoring ." ]
appropriate sedation benefits patients by reducing the stress response , but it requires an appropriate method of assessment to adjust the dosage of sedatives . the aim of this study was to compare the difference in the sedation of mechanically ventilated patients undergoing flexible bronchoscopy ( fb ) monitored by auditory-evoked potentials ( aeps ) or the ramsay sedation scale ( rss ) . in a prospective , randomized , controlled study , all patients who underwent fb with propofol sedation were monitored and their sedation adjusted . during fb , one group was monitored by aep and another group was monitored by rss . the propofol dosage was adjusted by the nursing staff during examination to maintain the alaris aep index ( aai ) value between @ and @ in the aep group and the rss at @ or @ in the rss group . before fb and during fb , the aai , heart rate ( hr ) , and mean arterial pressure ( map ) were recorded every @ min . the percentages of time at the sedation target and the propofol dosages were calculated . nineteen patients received aep monitoring and @ patients received rss monitoring . the percentage of time at the sedation target during fb was significantly higher in the aep monitoring group ( @ % ; interquartile range -lsb- iqr -rsb- , @-@ @ % ) than in the rss group ( @ % ; iqr , @-@ @ % ) , ( p < @ ) . during fb , the rss group had a significantly higher aai ( p = @ ) , hr ( p < @ ) , and map ( p < @ ) than the aep group . in mechanically ventilated patients undergoing fb , aep monitoring resulted in less variation in aai , hr , and map , and a higher percentage of time at the sedation target than rss monitoring .
24,499,010
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "given increasing rates of resistance to existing therapy , new options for treatment and prophylaxis of malaria are needed .", "two randomised , comparative , non-inferiority studies were conducted in africa , one double-blinded and one open-label .", "adults with fever , a positive peripheral blood smear , and a positive rapid diagnostic test for plasmodium falciparum were randomised in both studies to either azithromycin ( az ) @,@ mg plus chloroquine ( cq ) @-mg base ( azcq @,@ mg ) once daily for three days or mefloquine hydrochloride ( mq ) @,@ mg ( split dose ) .", "in the first study , an additional regimen of az @ mg plus cq @-mg base ( azcq @ mg ) once daily for three days was included .", "all study participants were hospitalised until three consecutive daily blood smears were negative for asexual p. falciparum parasitaemia .", "study participants were evaluated weekly for @ days , with day @ polymerase chain reaction ( pcr ) - corrected parasitological clearance rate as primary endpoint .", "a total of @ subjects were randomised in the two studies .", "at @ days ' follow-up , pcr-corrected parasitological clearance rates in the per protocol population in the first study were @/@ ( @ % ) with azcq @,@ mg compared with @/@ ( @ % ) with mq ( @ % confidence interval -lsb- ci -rsb- : -@ , @ ) .", "the azcq @-mg regimen was stopped during an interim study review ( six -lsb- @ % -rsb- clearance of seven evaluable ; two lost to follow-up ) .", "in the second study , clearance rates were similar : azcq @,@ mg @/@ ( @ % ) vs mq @/@ ( @ % ; @ % ci : -@ , @ ) .", "among the participating countries , in vitro cq resistance based on pfcrt mutation frequency in the baseline isolates across both studies ranged from @ % ( zambia ) to @ % ( uganda ) .", "serious adverse events ( aes ; all causality ) were observed more frequently with mq compared with azcq ( four vs one , respectively ) , though discontinuations for aes were similar ( four vs three , respectively ) .", "common aes in the az-containing arms included pruritus , vomiting , dizziness , and headache .", "among adults with symptomatic uncomplicated falciparum malaria in africa , the combination of az @,@ mg and cq @-mg base once daily for three days resulted in day @ pcr-corrected parasitological clearance rates of @ % and was non-inferior to treatment with mq .", "azcq was well tolerated .", "clinicaltrials.gov identifiers nct@ and nct@ ." ]
given increasing rates of resistance to existing therapy , new options for treatment and prophylaxis of malaria are needed . two randomised , comparative , non-inferiority studies were conducted in africa , one double-blinded and one open-label . adults with fever , a positive peripheral blood smear , and a positive rapid diagnostic test for plasmodium falciparum were randomised in both studies to either azithromycin ( az ) @,@ mg plus chloroquine ( cq ) @-mg base ( azcq @,@ mg ) once daily for three days or mefloquine hydrochloride ( mq ) @,@ mg ( split dose ) . in the first study , an additional regimen of az @ mg plus cq @-mg base ( azcq @ mg ) once daily for three days was included . all study participants were hospitalised until three consecutive daily blood smears were negative for asexual p. falciparum parasitaemia . study participants were evaluated weekly for @ days , with day @ polymerase chain reaction ( pcr ) - corrected parasitological clearance rate as primary endpoint . a total of @ subjects were randomised in the two studies . at @ days ' follow-up , pcr-corrected parasitological clearance rates in the per protocol population in the first study were @/@ ( @ % ) with azcq @,@ mg compared with @/@ ( @ % ) with mq ( @ % confidence interval -lsb- ci -rsb- : -@ , @ ) . the azcq @-mg regimen was stopped during an interim study review ( six -lsb- @ % -rsb- clearance of seven evaluable ; two lost to follow-up ) . in the second study , clearance rates were similar : azcq @,@ mg @/@ ( @ % ) vs mq @/@ ( @ % ; @ % ci : -@ , @ ) . among the participating countries , in vitro cq resistance based on pfcrt mutation frequency in the baseline isolates across both studies ranged from @ % ( zambia ) to @ % ( uganda ) . serious adverse events ( aes ; all causality ) were observed more frequently with mq compared with azcq ( four vs one , respectively ) , though discontinuations for aes were similar ( four vs three , respectively ) . common aes in the az-containing arms included pruritus , vomiting , dizziness , and headache . among adults with symptomatic uncomplicated falciparum malaria in africa , the combination of az @,@ mg and cq @-mg base once daily for three days resulted in day @ pcr-corrected parasitological clearance rates of @ % and was non-inferior to treatment with mq . azcq was well tolerated . clinicaltrials.gov identifiers nct@ and nct@ .
25,425,434
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the phase @ lume-lung @ study assessed the efficacy and safety of docetaxel plus nintedanib as second-line therapy for non-small-cell lung cancer ( nsclc ) .", "patients from @ centres in @ countries with stage iiib/iv recurrent nsclc progressing after first-line chemotherapy , stratified by ecog performance status , previous bevacizumab treatment , histology , and presence of brain metastases , were allocated ( by computer-generated sequence through an interactive third-party system , in @:@ ratio ) , to receive docetaxel @ mg/m ( @ ) by intravenous infusion on day @ plus either nintedanib @ mg orally twice daily or matching placebo on days @-@ , every @ weeks until unacceptable adverse events or disease progression .", "investigators and patients were masked to assignment .", "the primary endpoint was progression-free survival ( pfs ) by independent central review , analysed by intention to treat after @ events in all patients .", "the key secondary endpoint was overall survival , analysed by intention to treat after @ events had occurred , in a prespecified stepwise order : first in patients with adenocarcinoma who progressed within @ months after start of first-line therapy , then in all patients with adenocarcinoma , then in all patients .", "this trial is registered with clinicaltrials.gov , number nct@ .", "between dec @ , @ , and feb @ , @ , @ patients were randomly assigned to receive docetaxel plus nintedanib and @ to receive docetaxel plus placebo .", "the primary analysis was done after a median follow-up of @ months ( iqr @-@ ) .", "pfs was significantly improved in the docetaxel plus nintedanib group compared with the docetaxel plus placebo group ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hazard ratio -lsb- hr -rsb- @ -lsb- @ % ci @-@ -rsb- , p = @ ) .", "after a median follow-up of @ months ( iqr @-@ ) , overall survival was significantly improved for patients with adenocarcinoma histology who progressed within @ months after start of first-line treatment in the docetaxel plus nintedanib group ( @ patients ) compared with those in the docetaxel plus placebo group ( @ patients ; median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hr @ -lsb- @ % ci @-@ -rsb- , p = @ ) .", "similar results were noted for all patients with adenocarcinoma histology ( @ patients in the docetaxel plus nintedanib group and @ in the docetaxel plus placebo group ; median overall survival @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @ % ci @-@ -rsb- ; hr @ -lsb- @ % ci @-@ -rsb- , p = @ ) , but not in the total study population ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hr @ , @ % ci @-@ , p = @ ) .", "grade @ or worse adverse events that were more common in the docetaxel plus nintedanib group than in the docetaxel plus placebo group were diarrhoea ( @ -lsb- @ % -rsb- of @ vs @ -lsb- @ % -rsb- of @ ) , reversible increases in alanine aminotransferase ( @ -lsb- @ % -rsb- vs six -lsb- @ % -rsb- ) , and reversible increases in aspartate aminotransferase ( @ -lsb- @ % -rsb- vs three -lsb- @ % -rsb- ) .", "@ patients in the docetaxel plus nintedanib group and @ in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression ; the most common of these events were sepsis ( five with docetaxel plus nintedanib vs one with docetaxel plus placebo ) , pneumonia ( two vs seven ) , respiratory failure ( four vs none ) , and pulmonary embolism ( none vs three ) .", "nintedanib in combination with docetaxel is an effective second-line option for patients with advanced nsclc previously treated with one line of platinum-based therapy , especially for patients with adenocarcinoma .", "boehringer ingelheim ." ]
the phase @ lume-lung @ study assessed the efficacy and safety of docetaxel plus nintedanib as second-line therapy for non-small-cell lung cancer ( nsclc ) . patients from @ centres in @ countries with stage iiib/iv recurrent nsclc progressing after first-line chemotherapy , stratified by ecog performance status , previous bevacizumab treatment , histology , and presence of brain metastases , were allocated ( by computer-generated sequence through an interactive third-party system , in @:@ ratio ) , to receive docetaxel @ mg/m ( @ ) by intravenous infusion on day @ plus either nintedanib @ mg orally twice daily or matching placebo on days @-@ , every @ weeks until unacceptable adverse events or disease progression . investigators and patients were masked to assignment . the primary endpoint was progression-free survival ( pfs ) by independent central review , analysed by intention to treat after @ events in all patients . the key secondary endpoint was overall survival , analysed by intention to treat after @ events had occurred , in a prespecified stepwise order : first in patients with adenocarcinoma who progressed within @ months after start of first-line therapy , then in all patients with adenocarcinoma , then in all patients . this trial is registered with clinicaltrials.gov , number nct@ . between dec @ , @ , and feb @ , @ , @ patients were randomly assigned to receive docetaxel plus nintedanib and @ to receive docetaxel plus placebo . the primary analysis was done after a median follow-up of @ months ( iqr @-@ ) . pfs was significantly improved in the docetaxel plus nintedanib group compared with the docetaxel plus placebo group ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hazard ratio -lsb- hr -rsb- @ -lsb- @ % ci @-@ -rsb- , p = @ ) . after a median follow-up of @ months ( iqr @-@ ) , overall survival was significantly improved for patients with adenocarcinoma histology who progressed within @ months after start of first-line treatment in the docetaxel plus nintedanib group ( @ patients ) compared with those in the docetaxel plus placebo group ( @ patients ; median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hr @ -lsb- @ % ci @-@ -rsb- , p = @ ) . similar results were noted for all patients with adenocarcinoma histology ( @ patients in the docetaxel plus nintedanib group and @ in the docetaxel plus placebo group ; median overall survival @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @ % ci @-@ -rsb- ; hr @ -lsb- @ % ci @-@ -rsb- , p = @ ) , but not in the total study population ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hr @ , @ % ci @-@ , p = @ ) . grade @ or worse adverse events that were more common in the docetaxel plus nintedanib group than in the docetaxel plus placebo group were diarrhoea ( @ -lsb- @ % -rsb- of @ vs @ -lsb- @ % -rsb- of @ ) , reversible increases in alanine aminotransferase ( @ -lsb- @ % -rsb- vs six -lsb- @ % -rsb- ) , and reversible increases in aspartate aminotransferase ( @ -lsb- @ % -rsb- vs three -lsb- @ % -rsb- ) . @ patients in the docetaxel plus nintedanib group and @ in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression ; the most common of these events were sepsis ( five with docetaxel plus nintedanib vs one with docetaxel plus placebo ) , pneumonia ( two vs seven ) , respiratory failure ( four vs none ) , and pulmonary embolism ( none vs three ) . nintedanib in combination with docetaxel is an effective second-line option for patients with advanced nsclc previously treated with one line of platinum-based therapy , especially for patients with adenocarcinoma . boehringer ingelheim .
24,411,639
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to investigate the effects of cell therapy on myocardial perfusion recovery after treatment of acute myocardial infarction ( mi ) with primary percutaneous coronary intervention ( pci ) .", "in this hebe trial substudy , which was approved by the institutional review board ( trial registry number isrctn@ ) , the authors assessed the effects of intracoronary infusion with bone marrow-derived mononuclear cells ( bmmcs ) or peripheral blood-derived mononuclear cells ( pbmcs ) on myocardial perfusion recovery by using cardiac magnetic resonance ( mr ) imaging after revascularization .", "in @ patients with acute mi treated with pci , cardiac mr imaging was performed after obtaining informed consent-before randomization to bmmc , pbmc , or standard therapy ( control group ) - and repeated at @-month follow-up .", "cardiac mr imaging consisted of cine , rest first-pass perfusion , and late gadolinium enhancement imaging .", "perfusion was evaluated semiquantitatively with signal intensity-time curves by calculating the relative upslope ( percentage signal intensity change ) .", "the relative upslope was calculated for the mi core , adjacent border zone , and remote myocardium .", "perfusion differences among treatment groups or between baseline and follow-up were assessed with the wilcoxon signed rank or mann-whitney u test .", "at baseline , myocardial perfusion differed between the mi core ( median , @ % ; interquartile range -lsb- iqr -rsb- , @ % -@ % ) , border zone ( median , @ % ; iqr , @ % -@ % ) , and remote myocardium ( median , @ % ; iqr , @ % -@ % ) ( p < @ for all ) , with equal distribution among treatment groups .", "these interregional differences persisted at follow-up ( p < @ for all ) .", "no difference in perfusion recovery was found between the three treatment groups for any region .", "after revascularization of st-elevation mi , cell therapy does not augment the recovery of resting perfusion in either the mi core or border zone ." ]
to investigate the effects of cell therapy on myocardial perfusion recovery after treatment of acute myocardial infarction ( mi ) with primary percutaneous coronary intervention ( pci ) . in this hebe trial substudy , which was approved by the institutional review board ( trial registry number isrctn@ ) , the authors assessed the effects of intracoronary infusion with bone marrow-derived mononuclear cells ( bmmcs ) or peripheral blood-derived mononuclear cells ( pbmcs ) on myocardial perfusion recovery by using cardiac magnetic resonance ( mr ) imaging after revascularization . in @ patients with acute mi treated with pci , cardiac mr imaging was performed after obtaining informed consent-before randomization to bmmc , pbmc , or standard therapy ( control group ) - and repeated at @-month follow-up . cardiac mr imaging consisted of cine , rest first-pass perfusion , and late gadolinium enhancement imaging . perfusion was evaluated semiquantitatively with signal intensity-time curves by calculating the relative upslope ( percentage signal intensity change ) . the relative upslope was calculated for the mi core , adjacent border zone , and remote myocardium . perfusion differences among treatment groups or between baseline and follow-up were assessed with the wilcoxon signed rank or mann-whitney u test . at baseline , myocardial perfusion differed between the mi core ( median , @ % ; interquartile range -lsb- iqr -rsb- , @ % -@ % ) , border zone ( median , @ % ; iqr , @ % -@ % ) , and remote myocardium ( median , @ % ; iqr , @ % -@ % ) ( p < @ for all ) , with equal distribution among treatment groups . these interregional differences persisted at follow-up ( p < @ for all ) . no difference in perfusion recovery was found between the three treatment groups for any region . after revascularization of st-elevation mi , cell therapy does not augment the recovery of resting perfusion in either the mi core or border zone .
24,617,731
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the prevalence of chronic heart failure ( chf ) in spain is very high .", "it is the main cause of many hospital admissions and it is associated with high mortality rates .", "its management in primary care is not always adequate .", "our objective was to evaluate whether an educational intervention in general practitioners would improve the health care of their patients with chronic heart failure .", "prospective , randomised , and controlled study .", "a structured formative course was given to the intervention group ( ig ) of practitioners .", "a year later changes were compared with a control group ( cg ) .", "the settings were two primary care centres .", "one of them was in a rural setting , and the other one with a mixture of rural and urban populations .", "the study included @ patients diagnosed with chf , with a mean age of @ years , and they were assigned to @ practitioners ( total population : @ , @ ) we evaluated the quality of medical history , clinical examination , laboratory tests and treatment .", "at the end of the study there were marked differences between both groups .", "in the ig , the medical history improved @ points ( @ % ci : @ to @ ) , p = @ .", "the clinical examination improved @ points ( @ % ci : @ to @ ) , p > @ and the laboratory tests , @ points ( @ % ci : -@ to @ ) , p = @ ; the overall difference was @ points ( @ % cl : @ to @ ) , p > @ .", "there were slight improvements in treatment .", "the intervention promoted from our own work settings achieved a general improvement in the care of patients with heart failure ." ]
the prevalence of chronic heart failure ( chf ) in spain is very high . it is the main cause of many hospital admissions and it is associated with high mortality rates . its management in primary care is not always adequate . our objective was to evaluate whether an educational intervention in general practitioners would improve the health care of their patients with chronic heart failure . prospective , randomised , and controlled study . a structured formative course was given to the intervention group ( ig ) of practitioners . a year later changes were compared with a control group ( cg ) . the settings were two primary care centres . one of them was in a rural setting , and the other one with a mixture of rural and urban populations . the study included @ patients diagnosed with chf , with a mean age of @ years , and they were assigned to @ practitioners ( total population : @ , @ ) we evaluated the quality of medical history , clinical examination , laboratory tests and treatment . at the end of the study there were marked differences between both groups . in the ig , the medical history improved @ points ( @ % ci : @ to @ ) , p = @ . the clinical examination improved @ points ( @ % ci : @ to @ ) , p > @ and the laboratory tests , @ points ( @ % ci : -@ to @ ) , p = @ ; the overall difference was @ points ( @ % cl : @ to @ ) , p > @ . there were slight improvements in treatment . the intervention promoted from our own work settings achieved a general improvement in the care of patients with heart failure .
24,895,719
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the effects of hyperbaric and isobaric bupivacaine spinal anesthesia on hemodynamics and heart rate variability ( hrv ) in nonobstetric surgery .", "sixty patients were randomly allocated to @ groups .", "group i ( n = @ ) received @ mg ( @ ml ) of hyperbaric bupivacaine and group ii ( n = @ ) received @ mg ( @ ml ) of isobaric bupivacaine for spinal anesthesia .", "hemodynamic parameters were recorded before and after spinal anesthesia over @ min .", "analyses of hrv were performed on the day of surgery , after volume loading , and @ min after spinal injection .", "low frequency ( lf ) values , high frequency ( hf ) values , and lf/hf ratios were recorded .", "the incidences of hypotension and alterations of hrv parameters in both groups were investigated .", "the incidence ofhypotension was @ % and @ % in groups i and ii , respectively .", "there were no significant differences in the lf and hf values and lf/hf ratios between groups .", "in group i , lf/hf ratios were significantly lower and hf values were significantly higher at @ min after spinal anesthesia , in comparison to the baseline value ( p < @ ) .", "hyperbaric bupivacaine caused a significantly greater decrease in lf/hf ratios and a significantly greater increase in hf values ." ]
to compare the effects of hyperbaric and isobaric bupivacaine spinal anesthesia on hemodynamics and heart rate variability ( hrv ) in nonobstetric surgery . sixty patients were randomly allocated to @ groups . group i ( n = @ ) received @ mg ( @ ml ) of hyperbaric bupivacaine and group ii ( n = @ ) received @ mg ( @ ml ) of isobaric bupivacaine for spinal anesthesia . hemodynamic parameters were recorded before and after spinal anesthesia over @ min . analyses of hrv were performed on the day of surgery , after volume loading , and @ min after spinal injection . low frequency ( lf ) values , high frequency ( hf ) values , and lf/hf ratios were recorded . the incidences of hypotension and alterations of hrv parameters in both groups were investigated . the incidence ofhypotension was @ % and @ % in groups i and ii , respectively . there were no significant differences in the lf and hf values and lf/hf ratios between groups . in group i , lf/hf ratios were significantly lower and hf values were significantly higher at @ min after spinal anesthesia , in comparison to the baseline value ( p < @ ) . hyperbaric bupivacaine caused a significantly greater decrease in lf/hf ratios and a significantly greater increase in hf values .
25,566,589
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "an association between relatively deep anesthesia , as guided by the bispectral index ( bis ) , and increased postoperative mortality has been demonstrated in @ of @ published observational studies , but association does not necessarily mean causality .", "small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized , but have been inadequately powered to study mortality .", "a large-scale randomized study is required to determine whether causality exists .", "the primary hypothesis of our study is that `` light '' anesthesia , defined as a bis target of @ , will reduce all-cause mortality within @ year of surgery in comparison with `` deep '' anesthesia , defined as a bis target of @ , in patients aged @ years presenting for major surgery under general anesthesia .", "the trial is an international multicenter , randomized , parallel-group , double-blind ( patients and investigators ) prospective , intention-to-treat , safety and efficacy study .", "the relative reduction in mortality in the light anesthesia group is expected to be @ % , giving an absolute risk reduction from @ % to @ % .", "power analysis using a = @ and b = @ indicates that @ patients are required in each group .", "the study is underway , and @ patients have been recruited in @ centers in @ countries .", "it is anticipated that the study will be completed in @ years .", "this randomized controlled trial should definitively answer the question of whether titrating anesthetic depth makes a difference to patient outcome in a vulnerable patient group ." ]
an association between relatively deep anesthesia , as guided by the bispectral index ( bis ) , and increased postoperative mortality has been demonstrated in @ of @ published observational studies , but association does not necessarily mean causality . small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized , but have been inadequately powered to study mortality . a large-scale randomized study is required to determine whether causality exists . the primary hypothesis of our study is that `` light '' anesthesia , defined as a bis target of @ , will reduce all-cause mortality within @ year of surgery in comparison with `` deep '' anesthesia , defined as a bis target of @ , in patients aged @ years presenting for major surgery under general anesthesia . the trial is an international multicenter , randomized , parallel-group , double-blind ( patients and investigators ) prospective , intention-to-treat , safety and efficacy study . the relative reduction in mortality in the light anesthesia group is expected to be @ % , giving an absolute risk reduction from @ % to @ % . power analysis using a = @ and b = @ indicates that @ patients are required in each group . the study is underway , and @ patients have been recruited in @ centers in @ countries . it is anticipated that the study will be completed in @ years . this randomized controlled trial should definitively answer the question of whether titrating anesthetic depth makes a difference to patient outcome in a vulnerable patient group .
25,993,386
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the benefits of narrow band imaging ( nbi ) on enhancing colorectal adenoma detection remain questionable .", "we tested whether the new generation of nbi ( @-nbi ) , which is twice as bright as the previous version , would improve adenoma detection when compared with high-definition white light ( hd-wl ) colonoscopy .", "it was a randomized controlled trial with tandem colonoscopy .", "we recruited patients who underwent colonoscopy for symptoms , screening , or surveillance .", "patients were randomized for the use of either @-nbi or hd-wl on withdrawal .", "tandem colonoscopy was performed by using the same assigned colonoscope and withdrawal method .", "lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates , respectively .", "the primary outcomes were adenoma and polyp detection rates .", "a total of @ patients were randomized to undergo either @-nbi or hd-wl colonoscopy .", "both the adenoma and polyp detection rates were significantly higher in the @-nbi group compared with the hd-wl group ( adenoma : @ % vs. @ % , p = @ ; polyps : @ % vs. @ % , p = @ ) .", "the mean number of polyps detected per patient was higher in the @-nbi group ( @ % vs. @ , p = @ ) .", "there was no significant difference in the adenoma miss rates between the two groups ( @ % vs. @ % ) .", "multivariate analysis showed that the use of @-nbi ( odds ratio ( or ) @ ; @ % confidence interval ( ci ) @-@ @ ) , withdrawal time ( or @ ; ci @-@ @ ) , patient 's age ( or @ ; ci @-@ @ ) , and male gender ( or @ ; ci @-@ @ ) were associated with adenoma detection .", "@-nbi colonoscopy was superior to the conventional hd-wl in detecting colorectal adenomas or polyps , but there was no significant difference in adenoma miss rates ." ]
the benefits of narrow band imaging ( nbi ) on enhancing colorectal adenoma detection remain questionable . we tested whether the new generation of nbi ( @-nbi ) , which is twice as bright as the previous version , would improve adenoma detection when compared with high-definition white light ( hd-wl ) colonoscopy . it was a randomized controlled trial with tandem colonoscopy . we recruited patients who underwent colonoscopy for symptoms , screening , or surveillance . patients were randomized for the use of either @-nbi or hd-wl on withdrawal . tandem colonoscopy was performed by using the same assigned colonoscope and withdrawal method . lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates , respectively . the primary outcomes were adenoma and polyp detection rates . a total of @ patients were randomized to undergo either @-nbi or hd-wl colonoscopy . both the adenoma and polyp detection rates were significantly higher in the @-nbi group compared with the hd-wl group ( adenoma : @ % vs. @ % , p = @ ; polyps : @ % vs. @ % , p = @ ) . the mean number of polyps detected per patient was higher in the @-nbi group ( @ % vs. @ , p = @ ) . there was no significant difference in the adenoma miss rates between the two groups ( @ % vs. @ % ) . multivariate analysis showed that the use of @-nbi ( odds ratio ( or ) @ ; @ % confidence interval ( ci ) @-@ @ ) , withdrawal time ( or @ ; ci @-@ @ ) , patient 's age ( or @ ; ci @-@ @ ) , and male gender ( or @ ; ci @-@ @ ) were associated with adenoma detection . @-nbi colonoscopy was superior to the conventional hd-wl in detecting colorectal adenomas or polyps , but there was no significant difference in adenoma miss rates .
24,751,581
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the success rates of probing versus bicanalicular silastic intubation as the primary treatment for congenital nasolacrimal duct obstruction ( cnldo ) in children @year old .", "prospective , randomised , comparison .", "participants were randomised to undergo probing or bicanalicular silastic intubation .", "in bilateral cases , the right eye was used for analysis .", "the procedure was considered successful when all preoperative manifestations disappeared with normal dye disappearance test and a positive jones primary dye test at least @months postoperatively .", "secondary outcomes were risk factors for failure .", "outcomes were compared between treatments with p < @ indicating statistical significance .", "@ eyes of @ children between @ and @years old with cnldo who had not undergone previous surgical treatment were included in the study .", "@ eyes underwent probing with a @ % success rate and @ eyes that underwent bicanalicular silastic intubation had a @ % success rate ( p = @ ) .", "for simple cnldo , there was a @ % ( @/@ ) success rate with probing and a @ % ( @/@ ) success rate with bicanalicular silastic intubation ( p = @ ) .", "in complex cnldo , there was a @ % ( @/@ ; p = < @ ) success rate with probing and an @ % ( @/@ ; p = @ ) success rate with silastic intubation ( p = @ ) .", "age was not a risk factor for failure in either procedure .", "probing for simple cnldo in young children is adequate .", "bicanalicular silastic intubation seems to have a role in achieving successful outcomes in complex cnldo ." ]
to compare the success rates of probing versus bicanalicular silastic intubation as the primary treatment for congenital nasolacrimal duct obstruction ( cnldo ) in children @year old . prospective , randomised , comparison . participants were randomised to undergo probing or bicanalicular silastic intubation . in bilateral cases , the right eye was used for analysis . the procedure was considered successful when all preoperative manifestations disappeared with normal dye disappearance test and a positive jones primary dye test at least @months postoperatively . secondary outcomes were risk factors for failure . outcomes were compared between treatments with p < @ indicating statistical significance . @ eyes of @ children between @ and @years old with cnldo who had not undergone previous surgical treatment were included in the study . @ eyes underwent probing with a @ % success rate and @ eyes that underwent bicanalicular silastic intubation had a @ % success rate ( p = @ ) . for simple cnldo , there was a @ % ( @/@ ) success rate with probing and a @ % ( @/@ ) success rate with bicanalicular silastic intubation ( p = @ ) . in complex cnldo , there was a @ % ( @/@ ; p = < @ ) success rate with probing and an @ % ( @/@ ; p = @ ) success rate with silastic intubation ( p = @ ) . age was not a risk factor for failure in either procedure . probing for simple cnldo in young children is adequate . bicanalicular silastic intubation seems to have a role in achieving successful outcomes in complex cnldo .
25,185,252
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "despite recommendations against systematic screening for prostate cancer , @ % of patients still request prostate-specific antigen testing .", "to assess the impact of a decision aid on patients ' intention to undergo prostate cancer screening .", "randomised controlled trial with two-arm parallel groups in @ general practices in urban and rural areas in france .", "males aged @-@ years were randomised to receive either the decision aid ( intervention group ) or usual care ( control group ) .", "the primary outcome was the proportion of patients ' intending to undergo prostate cancer screening , assessed immediately after reading the decision aid .", "the reasons underlying their choice were elicited and the proportion of patients citing each reason to undergo , or not undergo , prostate cancer screening were compared between the two arms .", "a total of @ patients were randomised ( @ in the intervention arm ) from november @ to february @ .", "the proportion of patients who intended to be tested for prostate cancer in the intervention arm ( @ patients -lsb- @ % -rsb- ) was significantly reduced compared with the control arm ( @ patients -lsb- @ % -rsb- ) ( difference @ % , @ % confidence interval -lsb- ci -rsb- = @ to @ , p < @ ) .", "in the intervention group , a lower proportion of individuals expressed that cancer screening would protect them from the disease , compared with the control group ( p < @ ) , while a greater proportion of individuals stated that prostate cancer screening would not benefit their health ( p < @ ) and may involve procedures with harmful side effects ( p = @ ) .", "the decision aid improved participants ' informed decision making and reduced their intent to undergo prostate cancer screening ." ]
despite recommendations against systematic screening for prostate cancer , @ % of patients still request prostate-specific antigen testing . to assess the impact of a decision aid on patients ' intention to undergo prostate cancer screening . randomised controlled trial with two-arm parallel groups in @ general practices in urban and rural areas in france . males aged @-@ years were randomised to receive either the decision aid ( intervention group ) or usual care ( control group ) . the primary outcome was the proportion of patients ' intending to undergo prostate cancer screening , assessed immediately after reading the decision aid . the reasons underlying their choice were elicited and the proportion of patients citing each reason to undergo , or not undergo , prostate cancer screening were compared between the two arms . a total of @ patients were randomised ( @ in the intervention arm ) from november @ to february @ . the proportion of patients who intended to be tested for prostate cancer in the intervention arm ( @ patients -lsb- @ % -rsb- ) was significantly reduced compared with the control arm ( @ patients -lsb- @ % -rsb- ) ( difference @ % , @ % confidence interval -lsb- ci -rsb- = @ to @ , p < @ ) . in the intervention group , a lower proportion of individuals expressed that cancer screening would protect them from the disease , compared with the control group ( p < @ ) , while a greater proportion of individuals stated that prostate cancer screening would not benefit their health ( p < @ ) and may involve procedures with harmful side effects ( p = @ ) . the decision aid improved participants ' informed decision making and reduced their intent to undergo prostate cancer screening .
25,918,334
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to examine if supported employment ( se ) remains more effective than treatment as usual ( tau ) in returning veterans to competitive employment after spinal cord injury ( sci ) at @-year follow-up .", "prospective , randomized , controlled , multisite trial of se versus tau with @ months of follow-up .", "sci centers .", "subjects ( n = @ ) were enrolled and completed baseline interviews .", "at interventional sites , subjects were randomized to se ( n = @ ) or tau ( n = @ ) .", "at observational sites , @ subjects were enrolled in a nonrandomized tau condition .", "the intervention was a se program called the sci vocational integration program , which followed the principles of the individual placement and support model of se for persons with mental illness .", "competitive employment in the community within @ years .", "for the entire @-year follow-up period , se subjects were significantly more likely to achieve employment ( @ % ; @ % confidence interval -lsb- ci -rsb- , @-@ @ ) than either the tau subjects at the intervention sites ( @ % ; @ % ci , @-@ @ ; p < @ ) or the tau subjects at the observational sites ( @ % ; @ % ci , @-@ @ ; p < @ ) .", "most subjects who obtained competitive employment did so in year @ , and the average time to first employment was about @ weeks .", "se was better than usual practices in improving employment outcomes for veterans with sci across a @-year follow-up period .", "although se continued to be superior to traditional practices over the entire study , the first year of participation in se may represent a critical window for achieving employment after sci ." ]
to examine if supported employment ( se ) remains more effective than treatment as usual ( tau ) in returning veterans to competitive employment after spinal cord injury ( sci ) at @-year follow-up . prospective , randomized , controlled , multisite trial of se versus tau with @ months of follow-up . sci centers . subjects ( n = @ ) were enrolled and completed baseline interviews . at interventional sites , subjects were randomized to se ( n = @ ) or tau ( n = @ ) . at observational sites , @ subjects were enrolled in a nonrandomized tau condition . the intervention was a se program called the sci vocational integration program , which followed the principles of the individual placement and support model of se for persons with mental illness . competitive employment in the community within @ years . for the entire @-year follow-up period , se subjects were significantly more likely to achieve employment ( @ % ; @ % confidence interval -lsb- ci -rsb- , @-@ @ ) than either the tau subjects at the intervention sites ( @ % ; @ % ci , @-@ @ ; p < @ ) or the tau subjects at the observational sites ( @ % ; @ % ci , @-@ @ ; p < @ ) . most subjects who obtained competitive employment did so in year @ , and the average time to first employment was about @ weeks . se was better than usual practices in improving employment outcomes for veterans with sci across a @-year follow-up period . although se continued to be superior to traditional practices over the entire study , the first year of participation in se may represent a critical window for achieving employment after sci .
24,316,325
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "our objective was to evaluate the effectiveness of hands-on training at a bedside ultrasound ( us ) symposium ( `` ultrafest '' ) to improve both clinical knowledge and image acquisition skills of medical students .", "primary outcome measure was improvement in multiple choice questions on pulmonary or focused assessment with sonography in trauma ( fast ) us knowledge .", "secondary outcome was improvement in image acquisition for either pulmonary or fast .", "prospective cohort study of @ volunteers at `` ultrafest , '' a free symposium where students received five contact training hours .", "students were evaluated before and after training for proficiency in either pulmonary us or fast .", "proficiency was assessed by clinical knowledge through written multiple-choice exam , and clinical skills through accuracy of image acquisition .", "we used paired sample t-tests with students as their own controls .", "pulmonary knowledge scores increased by a mean of @ points ( @ % ci -lsb- @-@ @ -rsb- , p < @ ) , from @ to a posttest average of @ / @ possible points .", "the fast knowledge scores increased by a mean of @ points ( @ % ci -lsb- @-@ @ -rsb- p < @ ) , from @ to a posttest average of @ / @ .", "we analyzed clinical skills data on @ students .", "the mean score was @ pretest and @ posttest of @ possible points .", "mean improvement was @ points ( p < @ ) overall , @ ( p = @ ) for fast , and @ ( p = @ ) for the pulmonary us exam .", "this study suggests that a symposium on us can improve clinical knowledge , but is limited in achieving image acquisition for pulmonary and fast us assessments .", "us training external to official medical school curriculum may augment students ' education ." ]
our objective was to evaluate the effectiveness of hands-on training at a bedside ultrasound ( us ) symposium ( `` ultrafest '' ) to improve both clinical knowledge and image acquisition skills of medical students . primary outcome measure was improvement in multiple choice questions on pulmonary or focused assessment with sonography in trauma ( fast ) us knowledge . secondary outcome was improvement in image acquisition for either pulmonary or fast . prospective cohort study of @ volunteers at `` ultrafest , '' a free symposium where students received five contact training hours . students were evaluated before and after training for proficiency in either pulmonary us or fast . proficiency was assessed by clinical knowledge through written multiple-choice exam , and clinical skills through accuracy of image acquisition . we used paired sample t-tests with students as their own controls . pulmonary knowledge scores increased by a mean of @ points ( @ % ci -lsb- @-@ @ -rsb- , p < @ ) , from @ to a posttest average of @ / @ possible points . the fast knowledge scores increased by a mean of @ points ( @ % ci -lsb- @-@ @ -rsb- p < @ ) , from @ to a posttest average of @ / @ . we analyzed clinical skills data on @ students . the mean score was @ pretest and @ posttest of @ possible points . mean improvement was @ points ( p < @ ) overall , @ ( p = @ ) for fast , and @ ( p = @ ) for the pulmonary us exam . this study suggests that a symposium on us can improve clinical knowledge , but is limited in achieving image acquisition for pulmonary and fast us assessments . us training external to official medical school curriculum may augment students ' education .
25,671,024
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the efficacy and safety of ramucirumab ( imc-@b ; ly@ ) , a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-@ , alone and in combination with dacarbazine in chemotherapy-nave patients with metastatic melanoma ( mm ) .", "eligible patients received ramucirumab ( @mg/kg ) + dacarbazine ( @ mg/m ( @ ) ) ( arm a ) or ramucirumab only ( @mg/kg ) ( arm b ) every @ weeks .", "the primary end-point was progression-free survival ( pfs ) ; secondary end-points included overall survival ( os ) , overall response and safety .", "of @ randomised patients , @ received study treatment ( arm a , n = @ ; arm b , n = @ ) .", "baseline characteristics were similar in both arms .", "median pfs was @ months ( arm a ) and @ months ( arm b ) ; median @-month pfs rates were @ % and @ % and @-month pfs rates were @ % and @ % , respectively .", "in arm a , @ ( @ % ) patients had partial response ( pr ) and @ ( @ % ) , stable disease ( sd ) ; pr and sd in arm b were @ ( @ % ) and @ ( @ % ) , respectively .", "median os was @ months in arm a and @ months in arm b. patients in both arms tolerated the treatment with limited grade @/@ toxicities .", "ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with mm .", "although the study was not powered for comparison between treatment arms , pfs appeared greater with combination therapy .", "sustained disease control was observed on both study arm ." ]
to evaluate the efficacy and safety of ramucirumab ( imc-@b ; ly@ ) , a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-@ , alone and in combination with dacarbazine in chemotherapy-nave patients with metastatic melanoma ( mm ) . eligible patients received ramucirumab ( @mg/kg ) + dacarbazine ( @ mg/m ( @ ) ) ( arm a ) or ramucirumab only ( @mg/kg ) ( arm b ) every @ weeks . the primary end-point was progression-free survival ( pfs ) ; secondary end-points included overall survival ( os ) , overall response and safety . of @ randomised patients , @ received study treatment ( arm a , n = @ ; arm b , n = @ ) . baseline characteristics were similar in both arms . median pfs was @ months ( arm a ) and @ months ( arm b ) ; median @-month pfs rates were @ % and @ % and @-month pfs rates were @ % and @ % , respectively . in arm a , @ ( @ % ) patients had partial response ( pr ) and @ ( @ % ) , stable disease ( sd ) ; pr and sd in arm b were @ ( @ % ) and @ ( @ % ) , respectively . median os was @ months in arm a and @ months in arm b. patients in both arms tolerated the treatment with limited grade @/@ toxicities . ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with mm . although the study was not powered for comparison between treatment arms , pfs appeared greater with combination therapy . sustained disease control was observed on both study arm .
24,930,625
[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "many programs emphasize subsequent pregnancy prevention and high school graduation among teenage mothers ; however , less is known about their ability to increase financial earnings from employment opportunities while concurrently enrolled in school .", "this study evaluates factors influencing employment status among teenage mothers after enrolling in a community-based randomized intervention .", "project mothers and schools ( pmas ) initiative participants were surveyed at baseline and @ months after enrollment .", "the @ control group participants received homebound education and family case management , whereas the @ intervention group participants received these basic-level services as well as group parenting time , life skills , and leadership training .", "a generalized estimating equation was used to identify statistically significant changes associated with the intervention .", "participants were significantly more likely to receive money from their jobs at postintervention relative to baseline ( or = @ , p = @ ) ; however , this change was not statistically significant when comparing the control group to the intervention group .", "at postintervention , those who received money from parents were significantly less likely to receive money from their job ( or = @ , p = @ ) .", "while pmas benefited participants in terms of employment , the role of parental support requires additional investigation to determine its influence on teenage mothers ' ability to achieve financial independence ." ]
many programs emphasize subsequent pregnancy prevention and high school graduation among teenage mothers ; however , less is known about their ability to increase financial earnings from employment opportunities while concurrently enrolled in school . this study evaluates factors influencing employment status among teenage mothers after enrolling in a community-based randomized intervention . project mothers and schools ( pmas ) initiative participants were surveyed at baseline and @ months after enrollment . the @ control group participants received homebound education and family case management , whereas the @ intervention group participants received these basic-level services as well as group parenting time , life skills , and leadership training . a generalized estimating equation was used to identify statistically significant changes associated with the intervention . participants were significantly more likely to receive money from their jobs at postintervention relative to baseline ( or = @ , p = @ ) ; however , this change was not statistically significant when comparing the control group to the intervention group . at postintervention , those who received money from parents were significantly less likely to receive money from their job ( or = @ , p = @ ) . while pmas benefited participants in terms of employment , the role of parental support requires additional investigation to determine its influence on teenage mothers ' ability to achieve financial independence .
25,117,895
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the effect of two postnatal professional support interventions on the duration of any and exclusive breastfeeding .", "multicentre , three-arm , cluster randomised controlled trial .", "a cohort of @ primiparous breastfeeding mothers with uncomplicated , full-term pregnancies .", "the three study interventions were : ( @ ) standard postnatal maternity care ; ( @ ) standard care plus three in-hospital professional breastfeeding support sessions , of @-@minutes in duration ; or ( @ ) standard care plus weekly post-discharge breastfeeding telephone support , of @-@minutes in duration , for @weeks .", "the interventions were delivered by four trained research nurses , who were either highly experienced registered midwives or certified lactation consultants .", "prevalence of any and exclusive breastfeeding at @ , @ , and @months postpartum .", "rates of any and exclusive breastfeeding were higher among participants in the two intervention groups at all follow-up points , when compared with those who received standard care .", "participants receiving telephone support were significantly more likely to continue any breastfeeding at @month ( @ versus @ % ; odds ratio , or@ @ , @ % confidence interval , @ % ci @-@ @ ) and at @months ( @ versus @ % ; or@ @ , @ % ci @-@ @ ) , and to be exclusively breastfeeding at @month ( @ versus @ % ; or@ @ , @ % ci @-@ @ ) .", "participants in the in-hospital support group were also more likely to be breastfeeding at all time points , but the effect was not statistically significant .", "professional breastfeeding telephone support provided early in the postnatal period , and continued for the first month postpartum , improves breastfeeding duration among first-time mothers .", "it is also possible that it was the continuing nature of the support that increased the effectiveness of the intervention , rather than the delivery of the support by telephone specifically ." ]
to evaluate the effect of two postnatal professional support interventions on the duration of any and exclusive breastfeeding . multicentre , three-arm , cluster randomised controlled trial . a cohort of @ primiparous breastfeeding mothers with uncomplicated , full-term pregnancies . the three study interventions were : ( @ ) standard postnatal maternity care ; ( @ ) standard care plus three in-hospital professional breastfeeding support sessions , of @-@minutes in duration ; or ( @ ) standard care plus weekly post-discharge breastfeeding telephone support , of @-@minutes in duration , for @weeks . the interventions were delivered by four trained research nurses , who were either highly experienced registered midwives or certified lactation consultants . prevalence of any and exclusive breastfeeding at @ , @ , and @months postpartum . rates of any and exclusive breastfeeding were higher among participants in the two intervention groups at all follow-up points , when compared with those who received standard care . participants receiving telephone support were significantly more likely to continue any breastfeeding at @month ( @ versus @ % ; odds ratio , or@ @ , @ % confidence interval , @ % ci @-@ @ ) and at @months ( @ versus @ % ; or@ @ , @ % ci @-@ @ ) , and to be exclusively breastfeeding at @month ( @ versus @ % ; or@ @ , @ % ci @-@ @ ) . participants in the in-hospital support group were also more likely to be breastfeeding at all time points , but the effect was not statistically significant . professional breastfeeding telephone support provided early in the postnatal period , and continued for the first month postpartum , improves breastfeeding duration among first-time mothers . it is also possible that it was the continuing nature of the support that increased the effectiveness of the intervention , rather than the delivery of the support by telephone specifically .
24,861,802
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "alcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in germany are recently growing .", "the emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential `` teachable moment '' .", "however , studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication .", "in this protocol we present the halt-hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication .", "the trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after @ and @ months .", "n = @ participants aged @ years and younger will be recruited fridays to sundays in @ pediatric clinics over a period of @ months .", "intervention condition is a manual-based brief motivational intervention with a telephone booster after @ weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual .", "primary outcomes are reduction in binge drinking episodes , quantity of alcohol use on a typical drinking day and alcohol-related problems .", "secondary outcome is further treatment seeking .", "linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat ( itt ) and completers ( per-protocol ) principles to examine intervention effects .", "we also examine quantitative and qualitative process data on feasibility , intervention delivery , implementation and receipt from intervention providers , receivers and regular emergency department staff .", "the study has a number of strengths .", "first , a rigorous evaluation of halt-hamburg is timely because variations of the halt project are widely used in germany .", "second , prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication .", "third , we included a comprehensive process evaluation to raise external validity .", "fourth , the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact .", "current controlled trials isrctn@ ( april @th @ ) ." ]
alcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in germany are recently growing . the emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential `` teachable moment '' . however , studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication . in this protocol we present the halt-hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication . the trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after @ and @ months . n = @ participants aged @ years and younger will be recruited fridays to sundays in @ pediatric clinics over a period of @ months . intervention condition is a manual-based brief motivational intervention with a telephone booster after @ weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual . primary outcomes are reduction in binge drinking episodes , quantity of alcohol use on a typical drinking day and alcohol-related problems . secondary outcome is further treatment seeking . linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat ( itt ) and completers ( per-protocol ) principles to examine intervention effects . we also examine quantitative and qualitative process data on feasibility , intervention delivery , implementation and receipt from intervention providers , receivers and regular emergency department staff . the study has a number of strengths . first , a rigorous evaluation of halt-hamburg is timely because variations of the halt project are widely used in germany . second , prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication . third , we included a comprehensive process evaluation to raise external validity . fourth , the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact . current controlled trials isrctn@ ( april @th @ ) .
24,975,110
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "paclitaxel drug-eluting balloons ( pdeb ) could be an attractive option to minimise side branch ( sb ) restenosis in bifurcated coronary lesions .", "we compared angiographic and clinical outcomes with pdeb plus bare metal stent ( bms ) versus drug-eluting stents ( des ) in de novo bifurcated lesions .", "this multicentre randomised trial included @ patients .", "sequential main branch ( mb ) / sb dilatation with pdeb , with provisional t-stenting with bms in the mb was performed in the pdeb group , and with everolimus des in the des group .", "the primary endpoint was late lumen loss ( lll ) at nine months .", "the secondary endpoint was the incidence of major adverse cardiac events ( mace : death , myocardial infarction , or target lesion revascularisation ) .", "in-segment mb lll was @ mm in the pdeb group , and @ mm in the des group ( p = @ ) ; mean difference was @ mm ( upper limit one-sided @ % ci : @ mm ; p = @ ; non-inferiority test ) .", "lll in sb was -@ mm in the pdeb group and -@ mm in the des group ( p = @ ) .", "mace and tlr were higher in the pdeb group ( @ % vs. @ % ; p = @ , and @ % vs. @ % ; p = @ ) , due to higher mb restenosis ( @ % vs. @ % ; p = @ ) .", "pdeb bifurcation pretreatment with bms implantation in mb showed greater lll ( ns ) and increased incidence of mace compared to everolimus des .", "both strategies showed similar results in the sb ." ]
paclitaxel drug-eluting balloons ( pdeb ) could be an attractive option to minimise side branch ( sb ) restenosis in bifurcated coronary lesions . we compared angiographic and clinical outcomes with pdeb plus bare metal stent ( bms ) versus drug-eluting stents ( des ) in de novo bifurcated lesions . this multicentre randomised trial included @ patients . sequential main branch ( mb ) / sb dilatation with pdeb , with provisional t-stenting with bms in the mb was performed in the pdeb group , and with everolimus des in the des group . the primary endpoint was late lumen loss ( lll ) at nine months . the secondary endpoint was the incidence of major adverse cardiac events ( mace : death , myocardial infarction , or target lesion revascularisation ) . in-segment mb lll was @ mm in the pdeb group , and @ mm in the des group ( p = @ ) ; mean difference was @ mm ( upper limit one-sided @ % ci : @ mm ; p = @ ; non-inferiority test ) . lll in sb was -@ mm in the pdeb group and -@ mm in the des group ( p = @ ) . mace and tlr were higher in the pdeb group ( @ % vs. @ % ; p = @ , and @ % vs. @ % ; p = @ ) , due to higher mb restenosis ( @ % vs. @ % ; p = @ ) . pdeb bifurcation pretreatment with bms implantation in mb showed greater lll ( ns ) and increased incidence of mace compared to everolimus des . both strategies showed similar results in the sb .
24,832,638
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "women who deliver preterm infants are at a much greater risk for repeating a preterm birth ( ptb ) , compared to women without a history of ptb .", "however , little is known about the prevalence of the risk factors which account for this markedly increased risk .", "moreover , little or nothing is known about the feasibility of providing treatments and services to these women , outside of the context of prenatal care , during the inter-conception period , which provides the best opportunity for successful risk-reduction interventions .", "the philadelphia collaborative preterm prevention project ( pcppp ) , a large randomized control trial designed to identify and reduce six major risk factors for a repeat preterm birth among women immediately following the delivering of a preterm infant .", "for the women assigned to the pcppp treatment group , we calculated the prevalence of the six risk factors in question , the percentages of women who agreed to receive high quality risk-appropriate treatments or services , and the of rates of participation among those who were offered and eligible for these treatments or services .", "urogenital tract infections were identified in @ % of the women , while @ % were found to have periodontal disease .", "more than @ % were active smokers , and @ % were assessed with clinical depression .", "low literacy , and housing instability were identified in , @ and @ % of the study sample , respectively .", "among women eligible for intervention , the percentages who accepted and at least minimally participated in treatment ranged from a low of @ % for smoking , to a high of @ % for urogenital tract infection .", "most pcppp enrollees ( @ % ) had three or more major risk factors .", "participation rates associated with the pcppp treatments or services varied markedly , and were quite low in some cases , despite considerable efforts to reduce the barriers to receiving care .", "the efficacy of individual level risk-reduction efforts designed to prevent preterm/repeat preterm in the pre - or inter-conception period may be limited if participation rates associated with interventions to reduce major risk factors for ptb are low .", "achieving adequate participation may require identifying , better understanding , and eliminating barriers to access , beyond those associated with cost , transportation , childcare , and service location or hours of operation .", "clinicaltrials.gov ( nct@ ) ." ]
women who deliver preterm infants are at a much greater risk for repeating a preterm birth ( ptb ) , compared to women without a history of ptb . however , little is known about the prevalence of the risk factors which account for this markedly increased risk . moreover , little or nothing is known about the feasibility of providing treatments and services to these women , outside of the context of prenatal care , during the inter-conception period , which provides the best opportunity for successful risk-reduction interventions . the philadelphia collaborative preterm prevention project ( pcppp ) , a large randomized control trial designed to identify and reduce six major risk factors for a repeat preterm birth among women immediately following the delivering of a preterm infant . for the women assigned to the pcppp treatment group , we calculated the prevalence of the six risk factors in question , the percentages of women who agreed to receive high quality risk-appropriate treatments or services , and the of rates of participation among those who were offered and eligible for these treatments or services . urogenital tract infections were identified in @ % of the women , while @ % were found to have periodontal disease . more than @ % were active smokers , and @ % were assessed with clinical depression . low literacy , and housing instability were identified in , @ and @ % of the study sample , respectively . among women eligible for intervention , the percentages who accepted and at least minimally participated in treatment ranged from a low of @ % for smoking , to a high of @ % for urogenital tract infection . most pcppp enrollees ( @ % ) had three or more major risk factors . participation rates associated with the pcppp treatments or services varied markedly , and were quite low in some cases , despite considerable efforts to reduce the barriers to receiving care . the efficacy of individual level risk-reduction efforts designed to prevent preterm/repeat preterm in the pre - or inter-conception period may be limited if participation rates associated with interventions to reduce major risk factors for ptb are low . achieving adequate participation may require identifying , better understanding , and eliminating barriers to access , beyond those associated with cost , transportation , childcare , and service location or hours of operation . clinicaltrials.gov ( nct@ ) .
25,361,563
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "myoelectric prostheses use electromyographic ( emg ) signals to control movement of prosthetic joints .", "clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom ( dofs ) ; however , the use of implantable devices that record intramuscular emg signals could overcome this constraint .", "the objective of this study was to evaluate the real-time simultaneous control of three dofs ( wrist rotation , wrist flexion/extension , and hand open/close ) using intramuscular emg .", "we evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire emg : ( i ) parallel dual-site differential control , which enabled simultaneous control of three dofs and ( ii ) pattern recognition control , which required sequential control of dofs .", "over the course of the experiment , subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a fitts ' law test .", "by the end of the experiment , performance using parallel dual-site control was significantly better ( up to a @ % increase in throughput ) than when using sequential pattern recognition control for tasks requiring multiple dofs .", "the learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible .", "subjects occasionally experienced difficulty in performing isolated single-dof movements with parallel dual-site control but were able to accomplish related fitts ' law tasks with high levels of path efficiency .", "these results suggest that intramuscular emg , used in a parallel dual-site configuration , can provide simultaneous control of a multi-dof prosthetic wrist and hand and may outperform current methods that enforce sequential control ." ]
myoelectric prostheses use electromyographic ( emg ) signals to control movement of prosthetic joints . clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom ( dofs ) ; however , the use of implantable devices that record intramuscular emg signals could overcome this constraint . the objective of this study was to evaluate the real-time simultaneous control of three dofs ( wrist rotation , wrist flexion/extension , and hand open/close ) using intramuscular emg . we evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire emg : ( i ) parallel dual-site differential control , which enabled simultaneous control of three dofs and ( ii ) pattern recognition control , which required sequential control of dofs . over the course of the experiment , subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a fitts ' law test . by the end of the experiment , performance using parallel dual-site control was significantly better ( up to a @ % increase in throughput ) than when using sequential pattern recognition control for tasks requiring multiple dofs . the learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible . subjects occasionally experienced difficulty in performing isolated single-dof movements with parallel dual-site control but were able to accomplish related fitts ' law tasks with high levels of path efficiency . these results suggest that intramuscular emg , used in a parallel dual-site configuration , can provide simultaneous control of a multi-dof prosthetic wrist and hand and may outperform current methods that enforce sequential control .
25,394,366
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to simultaneously examine the effects of acute exercise intensity and free-living physical activity and sedentary behavior on cognitive function in young , healthy adults .", "using a counterbalanced , crossover , randomized controlled design , @ young adults ( mean age , @ years ) completed various cognitive assessments with and without an acute bout of exercise preceding the assessment .", "participants were randomized into @ of @ groups to complete a @-minute bout of acute exercise : control ( no exercise ) , light intensity ( @ % -@ % of predicted maximum heart rate -lsb- hr ( max ) -rsb- ) , moderate intensity ( @ % -@ % of predicted hr ( max ) ) , or vigorous intensity ( @ % -@ % of predicted hr ( max ) ) .", "subjectively and objectively determined ( accelerometry ) physical activity and sedentary behavior were assessed to examine the association between these free-living behaviors and cognitive function .", "the study duration was august @ , @ , to september @ , @ .", "concentration-related cognition ( mean sd feature match test score ) was significantly higher after a @-minute acute bout of moderate-intensity exercise ( @ ) compared with cognitive assessment without exercise ( @ ; p = @ ) .", "furthermore , questionnaire-determined sedentary behavior was inversely associated with visual attention and task switching ( trail making test a score ) ( = -@ ; p = @ ) .", "last , estimated cardiorespiratory fitness ( volume of maximum oxygen consumption ) was positively associated with reasoning-related cognitive function ( odd one out test score ) ( = @ ; p = @ ) ; when adding metabolic equivalent of task minutes per week to this model , the results were not significant ( = @ ; p = @ ) .", "these findings provide some support for acute moderate-intensity exercise , sedentary behavior , and cardiorespiratory fitness being associated with executive functioning-related cognitive function in young , healthy adults ." ]
to simultaneously examine the effects of acute exercise intensity and free-living physical activity and sedentary behavior on cognitive function in young , healthy adults . using a counterbalanced , crossover , randomized controlled design , @ young adults ( mean age , @ years ) completed various cognitive assessments with and without an acute bout of exercise preceding the assessment . participants were randomized into @ of @ groups to complete a @-minute bout of acute exercise : control ( no exercise ) , light intensity ( @ % -@ % of predicted maximum heart rate -lsb- hr ( max ) -rsb- ) , moderate intensity ( @ % -@ % of predicted hr ( max ) ) , or vigorous intensity ( @ % -@ % of predicted hr ( max ) ) . subjectively and objectively determined ( accelerometry ) physical activity and sedentary behavior were assessed to examine the association between these free-living behaviors and cognitive function . the study duration was august @ , @ , to september @ , @ . concentration-related cognition ( mean sd feature match test score ) was significantly higher after a @-minute acute bout of moderate-intensity exercise ( @ ) compared with cognitive assessment without exercise ( @ ; p = @ ) . furthermore , questionnaire-determined sedentary behavior was inversely associated with visual attention and task switching ( trail making test a score ) ( = -@ ; p = @ ) . last , estimated cardiorespiratory fitness ( volume of maximum oxygen consumption ) was positively associated with reasoning-related cognitive function ( odd one out test score ) ( = @ ; p = @ ) ; when adding metabolic equivalent of task minutes per week to this model , the results were not significant ( = @ ; p = @ ) . these findings provide some support for acute moderate-intensity exercise , sedentary behavior , and cardiorespiratory fitness being associated with executive functioning-related cognitive function in young , healthy adults .
25,746,399
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the purpose of this study was to assess the efficacy and safety of edivoxetine ( ly@ ) , a selective norepinephrine reuptake inhibitor , in pediatric patients with attention-deficit/hyperactivity disorder ( adhd ) .", "a fixed-dose , randomized , double-blind , @ week study was conducted in patients @-@ years of age , who were randomized by two strata : @ ) patients with prior stimulant use randomized to placebo , edivoxetine @ mg/kg/day , @ mg/kg/day , or @ mg/kg/day arms in a @:@:@:@ ratio ; @ ) stimulant-nave patients randomized to placebo , edivoxetine @ mg/kg/day , @ mg/kg/day , @ mg/kg/day , or osmotic-release oral system methylphenidate ( oros mph ) ( @-@mg / day based on body weight ) arms in a @:@:@:@:@ ratio .", "the primary efficacy measure was baseline-to-week @ change of adhd rating scale ( adhd-rs ) total score for edivoxetine @ mg/kg/day and @ mg/kg/day .", "a total of @ patients were randomized to placebo ( n = @ ) ; edivoxetine @ mg/kg/day ( n = @ ) , @ mg/kg/day ( n = @ ) , or @ mg/kg/day ( n = @ ) ; or oros mph ( n = @ ) .", "in the stimulant-nave stratum , the positive control , oros mph , was significantly superior to placebo in mean adhd-rs total score change at end-point ( -@ , p = @ ) .", "the edivoxetine @ mg/kg/day and @ mg/kg/day arms had statistically significantly greater improvement than the placebo arm in mean adhd-rs total score change at end-point ( placebo -@ ; edivoxetine @ mg/kg/day -@ , p < @ ; edivoxetine @ mg/kg/day -@ , p < @ ) and clinical global impressions-improvement score ( placebo @ ; edivoxetine @ mg/kg/day @ , p = @ ; edivoxetine @ mg/kg/day @ , p = @ ; edivoxetine @ mg/kg/day @ , p = @ ) .", "in the overall efficacy-analyses data set ( n = @ ) , the effect size estimates for edivoxetine doses @ mg/kg/day , @ mg/kg/day and @ mg/kg/day at the week @ time point were @ , @ , and @ , respectively ( for the stimulant-nave stratum , the effect size estimate for oros mph was @ ) .", "compared with placebo , edivoxetine treatment was associated with statistically significant increases in blood pressure and pulse ( p < @ ) , and a smaller increase or slight decrease in weight .", "edivoxetine at doses of @ mg/kg/day and @ mg/kg/day demonstrated efficacy in adhd treatment , despite the presence of a sizeable placebo response .", "no unexpected adverse events were identified .", "clinical trial registry identifier : nct@ ." ]
the purpose of this study was to assess the efficacy and safety of edivoxetine ( ly@ ) , a selective norepinephrine reuptake inhibitor , in pediatric patients with attention-deficit/hyperactivity disorder ( adhd ) . a fixed-dose , randomized , double-blind , @ week study was conducted in patients @-@ years of age , who were randomized by two strata : @ ) patients with prior stimulant use randomized to placebo , edivoxetine @ mg/kg/day , @ mg/kg/day , or @ mg/kg/day arms in a @:@:@:@ ratio ; @ ) stimulant-nave patients randomized to placebo , edivoxetine @ mg/kg/day , @ mg/kg/day , @ mg/kg/day , or osmotic-release oral system methylphenidate ( oros mph ) ( @-@mg / day based on body weight ) arms in a @:@:@:@:@ ratio . the primary efficacy measure was baseline-to-week @ change of adhd rating scale ( adhd-rs ) total score for edivoxetine @ mg/kg/day and @ mg/kg/day . a total of @ patients were randomized to placebo ( n = @ ) ; edivoxetine @ mg/kg/day ( n = @ ) , @ mg/kg/day ( n = @ ) , or @ mg/kg/day ( n = @ ) ; or oros mph ( n = @ ) . in the stimulant-nave stratum , the positive control , oros mph , was significantly superior to placebo in mean adhd-rs total score change at end-point ( -@ , p = @ ) . the edivoxetine @ mg/kg/day and @ mg/kg/day arms had statistically significantly greater improvement than the placebo arm in mean adhd-rs total score change at end-point ( placebo -@ ; edivoxetine @ mg/kg/day -@ , p < @ ; edivoxetine @ mg/kg/day -@ , p < @ ) and clinical global impressions-improvement score ( placebo @ ; edivoxetine @ mg/kg/day @ , p = @ ; edivoxetine @ mg/kg/day @ , p = @ ; edivoxetine @ mg/kg/day @ , p = @ ) . in the overall efficacy-analyses data set ( n = @ ) , the effect size estimates for edivoxetine doses @ mg/kg/day , @ mg/kg/day and @ mg/kg/day at the week @ time point were @ , @ , and @ , respectively ( for the stimulant-nave stratum , the effect size estimate for oros mph was @ ) . compared with placebo , edivoxetine treatment was associated with statistically significant increases in blood pressure and pulse ( p < @ ) , and a smaller increase or slight decrease in weight . edivoxetine at doses of @ mg/kg/day and @ mg/kg/day demonstrated efficacy in adhd treatment , despite the presence of a sizeable placebo response . no unexpected adverse events were identified . clinical trial registry identifier : nct@ .
24,840,045
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "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 ." ]
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 .
24,931,061
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "qigong is highly favoured among asian breast cancer survivors for enhancing health .", "this study examined the hypothesis that quality of life ( qol ) in the qigong group is better than the placebo ( aerobic ) or usual care group .", "a total of @ participants were randomly assigned to either the @-week kuala lumpur qigong trial or control groups in @-@ .", "measurement taken at baseline and post - intervention included qol , distress and fatigue .", "analysis of covariance ( ancova ) and kruskal wallis were used to examine for differences between groups in the measurements .", "there were @ consenting participants in this @week trial .", "the adherence rates were @ % for qigong and @ % for the placebo group .", "the qigong group showed significant marginal improvement in quality of life scores compared to placebo ( mean difference = @ unit ; p = @ ) , compared to usual care ( mean difference = @ unit ; p = @ ) on functional assessment cancer therapy-breast measure .", "there were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention ( @-week ) .", "cancer survivors who participated in the qigong intervention showed slightly better qol .", "follow up studies are greatly needed to evaluate which subgroups may best benefit from qigong .", "with a steep rise of cancer survivors , there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries ." ]
qigong is highly favoured among asian breast cancer survivors for enhancing health . this study examined the hypothesis that quality of life ( qol ) in the qigong group is better than the placebo ( aerobic ) or usual care group . a total of @ participants were randomly assigned to either the @-week kuala lumpur qigong trial or control groups in @-@ . measurement taken at baseline and post - intervention included qol , distress and fatigue . analysis of covariance ( ancova ) and kruskal wallis were used to examine for differences between groups in the measurements . there were @ consenting participants in this @week trial . the adherence rates were @ % for qigong and @ % for the placebo group . the qigong group showed significant marginal improvement in quality of life scores compared to placebo ( mean difference = @ unit ; p = @ ) , compared to usual care ( mean difference = @ unit ; p = @ ) on functional assessment cancer therapy-breast measure . there were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention ( @-week ) . cancer survivors who participated in the qigong intervention showed slightly better qol . follow up studies are greatly needed to evaluate which subgroups may best benefit from qigong . with a steep rise of cancer survivors , there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries .
25,338,995
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "our goal was to evaluate the effect of breakfast size and composition on body weight , glycemic control , and metabolic markers in adults with type @ diabetes mellitus ( t@dm ) .", "@ overweight/obese adults with t@dm were randomized to one of two isocaloric diabetic diets for @ months ; big breakfast ( bb ) , breakfast was rich in fat and protein and provided @ % of total daily energy or small breakfast ( sb ) , breakfast was rich in carbohydrates and provided @ % of total daily energy .", "although body weight was reduced similarly in both groups , the bb group showed greater hba@c and systolic blood pressure reductions ( hba@c : -@ % vs. -@ % , p = @ ; sbp -@ vs. -@ mmhg ; p = @ ) .", "t@dm medication dose was reduced in a greater proportion of the bb participants ( @ % vs. @ % ; p = @ ) while in the sb , a greater proportion of participants had a dose increases ( @ % vs. @ % ; p = @ ) .", "hunger scores were lower in the bb group and greater improvements in fasting glucose were observed in the bb group .", "a simple dietary manipulation enriching breakfast with energy as protein and fat appears to confer metabolic benefits and might be a useful alternative for the management of t@dm ." ]
our goal was to evaluate the effect of breakfast size and composition on body weight , glycemic control , and metabolic markers in adults with type @ diabetes mellitus ( t@dm ) . @ overweight/obese adults with t@dm were randomized to one of two isocaloric diabetic diets for @ months ; big breakfast ( bb ) , breakfast was rich in fat and protein and provided @ % of total daily energy or small breakfast ( sb ) , breakfast was rich in carbohydrates and provided @ % of total daily energy . although body weight was reduced similarly in both groups , the bb group showed greater hba@c and systolic blood pressure reductions ( hba@c : -@ % vs. -@ % , p = @ ; sbp -@ vs. -@ mmhg ; p = @ ) . t@dm medication dose was reduced in a greater proportion of the bb participants ( @ % vs. @ % ; p = @ ) while in the sb , a greater proportion of participants had a dose increases ( @ % vs. @ % ; p = @ ) . hunger scores were lower in the bb group and greater improvements in fasting glucose were observed in the bb group . a simple dietary manipulation enriching breakfast with energy as protein and fat appears to confer metabolic benefits and might be a useful alternative for the management of t@dm .
24,311,451
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the association between baseline comprehensive geriatric assessment ( cga ) or the groningen frailty indicator ( gfi ) and toxicity in elderly metastatic breast cancer ( mbc ) patients treated with first-line palliative chemotherapy .", "mbc patients ( @ years ) were randomized between pegylated liposomal doxorubicine or capecitabine .", "cga included instrumental activities of daily living ( iadl ) , cognition using the mini-mental state examination ( mmse ) , mood using the geriatric depression scale ( gds ) , comorbidity using the charlson index , polypharmacy and nutritional status using the body mass index .", "frailty on cga was defined as one or more of the following : iadl@ , mmse@ , gds@ , bmi@ , @ medications or charlson @ .", "the cut-off for frailty on the gfi was @ .", "of the randomized @ patients ( median age @ years , range @-@ @ years ) , @ were evaluable for cga ; @ ( @ % ) had one or more geriatric conditions .", "grade @-@ chemotherapy-related toxicity was experienced by @ % of patients without geriatric conditions compared to @ % of patients with two geriatric conditions and @ % of those with three or more ( p = @ ) .", "polypharmacy was the only individual factor significantly associated with toxicity ( p = @ ) .", "gfi had a sensitivity of @ % and a specificity of @ % for frailty on cga , and was not significantly associated with survival or toxicity .", "in this study of elderly patients with mbc , the number of geriatric conditions correlated with grade @-@ chemotherapy-related toxicity .", "therefore , in elderly patients for whom chemotherapy is being considered , a cga could be a useful addition to the decision-making process ." ]
to evaluate the association between baseline comprehensive geriatric assessment ( cga ) or the groningen frailty indicator ( gfi ) and toxicity in elderly metastatic breast cancer ( mbc ) patients treated with first-line palliative chemotherapy . mbc patients ( @ years ) were randomized between pegylated liposomal doxorubicine or capecitabine . cga included instrumental activities of daily living ( iadl ) , cognition using the mini-mental state examination ( mmse ) , mood using the geriatric depression scale ( gds ) , comorbidity using the charlson index , polypharmacy and nutritional status using the body mass index . frailty on cga was defined as one or more of the following : iadl@ , mmse@ , gds@ , bmi@ , @ medications or charlson @ . the cut-off for frailty on the gfi was @ . of the randomized @ patients ( median age @ years , range @-@ @ years ) , @ were evaluable for cga ; @ ( @ % ) had one or more geriatric conditions . grade @-@ chemotherapy-related toxicity was experienced by @ % of patients without geriatric conditions compared to @ % of patients with two geriatric conditions and @ % of those with three or more ( p = @ ) . polypharmacy was the only individual factor significantly associated with toxicity ( p = @ ) . gfi had a sensitivity of @ % and a specificity of @ % for frailty on cga , and was not significantly associated with survival or toxicity . in this study of elderly patients with mbc , the number of geriatric conditions correlated with grade @-@ chemotherapy-related toxicity . therefore , in elderly patients for whom chemotherapy is being considered , a cga could be a useful addition to the decision-making process .
24,314,824
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "hereditary haemochromatosis may result in severe organ damage which can be prevented by therapy .", "we studied the possible advantages and disadvantages of erythrocytapheresis as compared with phlebotomy in patients with hereditary haemochromatosis .", "in a prospective , randomised , open-label study , patients with hereditary haemochromatosis were randomised to bi-weekly apheresis or weekly whole blood phlebotomy .", "primary end-points were decrease in ferritin levels and transferrin saturation .", "secondary endpoints were decrease in haemoglobin levels , discomfort during the therapeutic procedure , costs and technicians ' working time .", "sixty-two patients were included .", "thirty patients were randomised to apheresis and @ to whole blood phlebotomy .", "initially , ferritin levels declined more rapidly in the apheresis group , and the difference became statistically highly significant at @ weeks ; however , time to normalisation of ferritin level was equal in the two groups .", "we observed no significant differences in decline of transferrin saturation , haemoglobin levels or discomfort .", "the mean cumulative technician time consumption until the ferritin level reached @ g/l was longer in the apheresis group , but the difference was not statistically significant .", "the cumulative costs for materials until achievement of the desired ferritin levels were three-fold higher in the apheresis group .", "treatment of hereditary haemochromatosis with erythrocytapheresis instead of whole blood phlebotomy results in a more rapid initial decline in ferritin levels and a reduced number of procedures per patient , but not in earlier achievement of target ferritin level .", "the frequency of discomfort was equally low with the two methods .", "the costs and , probably , technician time consumption were higher in the apheresis group ." ]
hereditary haemochromatosis may result in severe organ damage which can be prevented by therapy . we studied the possible advantages and disadvantages of erythrocytapheresis as compared with phlebotomy in patients with hereditary haemochromatosis . in a prospective , randomised , open-label study , patients with hereditary haemochromatosis were randomised to bi-weekly apheresis or weekly whole blood phlebotomy . primary end-points were decrease in ferritin levels and transferrin saturation . secondary endpoints were decrease in haemoglobin levels , discomfort during the therapeutic procedure , costs and technicians ' working time . sixty-two patients were included . thirty patients were randomised to apheresis and @ to whole blood phlebotomy . initially , ferritin levels declined more rapidly in the apheresis group , and the difference became statistically highly significant at @ weeks ; however , time to normalisation of ferritin level was equal in the two groups . we observed no significant differences in decline of transferrin saturation , haemoglobin levels or discomfort . the mean cumulative technician time consumption until the ferritin level reached @ g/l was longer in the apheresis group , but the difference was not statistically significant . the cumulative costs for materials until achievement of the desired ferritin levels were three-fold higher in the apheresis group . treatment of hereditary haemochromatosis with erythrocytapheresis instead of whole blood phlebotomy results in a more rapid initial decline in ferritin levels and a reduced number of procedures per patient , but not in earlier achievement of target ferritin level . the frequency of discomfort was equally low with the two methods . the costs and , probably , technician time consumption were higher in the apheresis group .
24,333,062
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "smoflipid @ % is intravenous lipid emulsion ( ile ) containing long-chain triglycerides ( lct ) , medium-chain triglycerides ( mct ) , olive oil , and fish oil as a mixed emulsion containing - tocopherol .", "the aim was to assess the efficacy of this new ile in gastrointestinal surgery compared with mct/lct .", "in this prospective study , @ patients were randomized to smoflipid @ % or mct/lct ( lipovenoes @ % ) group .", "clinical and biochemistry data were collected .", "inflammatory markers ( crp , il-@ , il-@ , tnf - , tgf-@ ) and oxidative stress ( ros and superoxide ) were measured .", "thirty-five patients ( @ males and @ females ) with a mean age of @ years completed the study .", "the patients ' demographic characteristics ( age , gender , height , body weight , and bmi ) were similar without significant differences between groups .", "the increment of triglyceride on day @ from baseline was significantly lower in smoflipid group than in lipovenoes mct/lct group .", "inflammatory markers , as well as superoxide radical and total oxygen radical were not different between groups .", "despite the comparable effect on inflammatory response , because of its well-balanced fatty acid pattern , relatively low n-@ : n-@ ratio , and high vitamin e content , smoflipid had a better triglyceride-lowering effect as compared with mct/lct in adult patients undergoing gastrointestinal surgery ." ]
smoflipid @ % is intravenous lipid emulsion ( ile ) containing long-chain triglycerides ( lct ) , medium-chain triglycerides ( mct ) , olive oil , and fish oil as a mixed emulsion containing - tocopherol . the aim was to assess the efficacy of this new ile in gastrointestinal surgery compared with mct/lct . in this prospective study , @ patients were randomized to smoflipid @ % or mct/lct ( lipovenoes @ % ) group . clinical and biochemistry data were collected . inflammatory markers ( crp , il-@ , il-@ , tnf - , tgf-@ ) and oxidative stress ( ros and superoxide ) were measured . thirty-five patients ( @ males and @ females ) with a mean age of @ years completed the study . the patients ' demographic characteristics ( age , gender , height , body weight , and bmi ) were similar without significant differences between groups . the increment of triglyceride on day @ from baseline was significantly lower in smoflipid group than in lipovenoes mct/lct group . inflammatory markers , as well as superoxide radical and total oxygen radical were not different between groups . despite the comparable effect on inflammatory response , because of its well-balanced fatty acid pattern , relatively low n-@ : n-@ ratio , and high vitamin e content , smoflipid had a better triglyceride-lowering effect as compared with mct/lct in adult patients undergoing gastrointestinal surgery .
24,285,251
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to explore therapeutic effect and action mechanism of regulating spleen-stomach needling on diabetic nephropathy ( dn ) .", "using multi-centric , randomized , controlled and blind principles , @ cases of dn were divided into an observation group and a control group according to random digital tab , @ cases in each one .", "based on regular treatment of diabetes , the regulating spleen-stomach needling was applied at zhongwan ( cv @ ) , quchi ( li @ ) , hegu ( li @ ) and xuehai ( sp @ ) , etc. in the observation group while shenshu ( bl @ ) , taixi ( ki @ ) , sanyinjiao ( sp @ ) , yanglingquan ( gb @ ) , etc. were selected in the control group by reference of acupuncture and moxibustion .", "the treatment was given twice a day , six days as a treatment session with interval of one day between sessions .", "totally six weeks were required .", "changes of clinical symptoms and signs , fast blood glucose ( fbg ) , urinary albumin excretion rate ( uaer ) , beta@-microglobulin ( beta@-mg ) , monocyte chemotactic protein-@ ( mcp-@ ) , lymphocyte membrane cholesterol , propanediol ( mda ) , pco , @-hydroxydeoxy guanosine ( @-ohdg ) , superoxide dismutase ( sod ) , cd@ + , cd@ + , cd@ + , and cd@ + / cd@ + were observed before and after treatment in two groups .", "as for improving clinical symptoms and signs , total effective rate was @ % ( @/@ ) in the observation group and @ % ( @/@ ) in the control group , which had statistical difference between two groups ( p < @ ) .", "as for regulating glycometabolism -lsb- ( @ + / - @ ) mmol/l vs ( @ + / - @ ) mmol/l -rsb- , reducing uaer -lsb- ( @ + / - @ ) mg/@h vs ( @ + / - @ ) mg/@h -rsb- , restraining over-expression of mcp-@ -lsb- ( @ + / - @ ) pg/ml vs ( @ + / - @ ) pg/ml -rsb- , regulating level of oxidative stress , prohibiting oxidation of protein and adjusting quantity and activity of t lymphocyte subgroup , the observation group was superior to the control group ( p < @ , p < @ ) .", "the regulating spleen-stomach needling is an effective method for treatment of dn , which cold improve glycometabolism disturbance-induced progressive kidney injury , recover glomerular filtration , reduce urinary albumin excretion rate , restrain overexpression of mcp-@ , adjust level of oxidative stress , prohibit oxidation of protein , increase protectiveness of membrane , adjust quantity and activity abnormity of t lymphocyte subgroup , leading to repairing lymphocyte damage and improving immune expression to delay kidney damage ." ]
to explore therapeutic effect and action mechanism of regulating spleen-stomach needling on diabetic nephropathy ( dn ) . using multi-centric , randomized , controlled and blind principles , @ cases of dn were divided into an observation group and a control group according to random digital tab , @ cases in each one . based on regular treatment of diabetes , the regulating spleen-stomach needling was applied at zhongwan ( cv @ ) , quchi ( li @ ) , hegu ( li @ ) and xuehai ( sp @ ) , etc. in the observation group while shenshu ( bl @ ) , taixi ( ki @ ) , sanyinjiao ( sp @ ) , yanglingquan ( gb @ ) , etc. were selected in the control group by reference of acupuncture and moxibustion . the treatment was given twice a day , six days as a treatment session with interval of one day between sessions . totally six weeks were required . changes of clinical symptoms and signs , fast blood glucose ( fbg ) , urinary albumin excretion rate ( uaer ) , beta@-microglobulin ( beta@-mg ) , monocyte chemotactic protein-@ ( mcp-@ ) , lymphocyte membrane cholesterol , propanediol ( mda ) , pco , @-hydroxydeoxy guanosine ( @-ohdg ) , superoxide dismutase ( sod ) , cd@ + , cd@ + , cd@ + , and cd@ + / cd@ + were observed before and after treatment in two groups . as for improving clinical symptoms and signs , total effective rate was @ % ( @/@ ) in the observation group and @ % ( @/@ ) in the control group , which had statistical difference between two groups ( p < @ ) . as for regulating glycometabolism -lsb- ( @ + / - @ ) mmol/l vs ( @ + / - @ ) mmol/l -rsb- , reducing uaer -lsb- ( @ + / - @ ) mg/@h vs ( @ + / - @ ) mg/@h -rsb- , restraining over-expression of mcp-@ -lsb- ( @ + / - @ ) pg/ml vs ( @ + / - @ ) pg/ml -rsb- , regulating level of oxidative stress , prohibiting oxidation of protein and adjusting quantity and activity of t lymphocyte subgroup , the observation group was superior to the control group ( p < @ , p < @ ) . the regulating spleen-stomach needling is an effective method for treatment of dn , which cold improve glycometabolism disturbance-induced progressive kidney injury , recover glomerular filtration , reduce urinary albumin excretion rate , restrain overexpression of mcp-@ , adjust level of oxidative stress , prohibit oxidation of protein , increase protectiveness of membrane , adjust quantity and activity abnormity of t lymphocyte subgroup , leading to repairing lymphocyte damage and improving immune expression to delay kidney damage .
24,617,227
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "we investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia .", "we performed genome-wide snp association studies of @-thioguanine and @-mercaptopurine cytotoxicity using lymphoblastoid cell lines .", "we then genotyped the top snps associated with lymphoblastoid cell line cytotoxicity , together with tagsnps for genes in the ` thiopurine pathway ' ( @ total snps ) , in dna from @ caucasian uk all@ patients .", "functional validation studies were performed by sirna knockdown in cancer cell lines .", "snps in the thiopurine pathway genes abcc@ , abcc@ , impdh@ , itpa , slc@a@ and xdh , and snps located within or near atp@ap@ , frmd@b , gng@ , kcnma@ and nme@ , were associated with clinical response and measures of thiopurine metabolism .", "functional validation showed shifts in cytotoxicity for these genes .", "the clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway ." ]
we investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia . we performed genome-wide snp association studies of @-thioguanine and @-mercaptopurine cytotoxicity using lymphoblastoid cell lines . we then genotyped the top snps associated with lymphoblastoid cell line cytotoxicity , together with tagsnps for genes in the ` thiopurine pathway ' ( @ total snps ) , in dna from @ caucasian uk all@ patients . functional validation studies were performed by sirna knockdown in cancer cell lines . snps in the thiopurine pathway genes abcc@ , abcc@ , impdh@ , itpa , slc@a@ and xdh , and snps located within or near atp@ap@ , frmd@b , gng@ , kcnma@ and nme@ , were associated with clinical response and measures of thiopurine metabolism . functional validation showed shifts in cytotoxicity for these genes . the clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway .
24,624,911
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "we performed a prospective , randomized , placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal ketamine and midazolam ( inkm ) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis .", "evaluation of modified objective pain score ( mops ) reduction in children undergoing inkm compared to the placebo group .", "evaluation of safety of inkm protocol , start time sedation effect , duration of sedation and evaluation of parents and doctors ' satisfaction about the procedure .", "in the sedation group , @ children , mean age @ months , received intranasal midazolam ( @ mg/kg ) and ketamine ( @ mg/kg ) .", "in the placebo group , @ children received normal saline solution twice in each nostril .", "the child 's degree of sedation was scored using the mops .", "a questionnaire was designed to evaluate the parents ' and doctors ' opinions on the procedures of both groups .", "fifty-seven gastric washings were performed in the sedation-group , while in the placebo-group we performed @ gastric aspirates .", "the degree of sedation achieved by inmk enabled all procedures to be completed without additional drugs .", "the mean duration of sedation was @ min .", "mean mops was @ ( range @-@ ) in the sedation-group , @ ( range @-@ ) in the placebo-group ( p < @ ) .", "the questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group .", "the only side effect registered was post-sedation agitation in @ procedures in the sedation group ( @ % ) .", "our experience suggests that atomized inkm makes gastric aspirates more acceptable and easy to perform in children .", "unique trial number : umin@ ; receipt number : r@ ." ]
we performed a prospective , randomized , placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal ketamine and midazolam ( inkm ) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis . evaluation of modified objective pain score ( mops ) reduction in children undergoing inkm compared to the placebo group . evaluation of safety of inkm protocol , start time sedation effect , duration of sedation and evaluation of parents and doctors ' satisfaction about the procedure . in the sedation group , @ children , mean age @ months , received intranasal midazolam ( @ mg/kg ) and ketamine ( @ mg/kg ) . in the placebo group , @ children received normal saline solution twice in each nostril . the child 's degree of sedation was scored using the mops . a questionnaire was designed to evaluate the parents ' and doctors ' opinions on the procedures of both groups . fifty-seven gastric washings were performed in the sedation-group , while in the placebo-group we performed @ gastric aspirates . the degree of sedation achieved by inmk enabled all procedures to be completed without additional drugs . the mean duration of sedation was @ min . mean mops was @ ( range @-@ ) in the sedation-group , @ ( range @-@ ) in the placebo-group ( p < @ ) . the questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group . the only side effect registered was post-sedation agitation in @ procedures in the sedation group ( @ % ) . our experience suggests that atomized inkm makes gastric aspirates more acceptable and easy to perform in children . unique trial number : umin@ ; receipt number : r@ .
24,598,046
[ "BACKGROUND", "METHODS", "RESULTS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to determine the optimal method for use of the canine brief pain inventory ( cbpi ) to quantitate responses of dogs with osteoarthritis to treatment with carprofen or placebo .", "@ dogs with osteoarthritis .", "data were analyzed from @ studies with identical protocols in which owner-completed cbpis were used .", "treatment for each dog was classified as a success or failure by comparing the pain severity score ( pss ) and pain interference score ( pis ) on day @ ( baseline ) with those on day @ .", "treatment success or failure was defined on the basis of various combinations of reduction in the @ scores when inclusion criteria were set as a pss and pis @ , @ , or @ at baseline .", "statistical analyses were performed to select the definition of treatment success that had the greatest statistical power to detect differences between carprofen and placebo treatments .", "defining treatment success as a reduction of @ in pss and @ in pis in each dog had consistently robust power .", "power was @ % in the population that included only dogs with baseline scores @ and @ % in the population that included only dogs with baseline scores @ .", "the cbpi had robust statistical power to evaluate the treatment effect of carprofen in dogs with osteoarthritis when protocol success criteria were predefined as a reduction @ in pis and @ in pss .", "results indicated the cbpi can be used as an outcome measure in clinical trials to evaluate new pain treatments when it is desirable to evaluate success in individual dogs rather than overall mean or median scores in a test population ." ]
to determine the optimal method for use of the canine brief pain inventory ( cbpi ) to quantitate responses of dogs with osteoarthritis to treatment with carprofen or placebo . @ dogs with osteoarthritis . data were analyzed from @ studies with identical protocols in which owner-completed cbpis were used . treatment for each dog was classified as a success or failure by comparing the pain severity score ( pss ) and pain interference score ( pis ) on day @ ( baseline ) with those on day @ . treatment success or failure was defined on the basis of various combinations of reduction in the @ scores when inclusion criteria were set as a pss and pis @ , @ , or @ at baseline . statistical analyses were performed to select the definition of treatment success that had the greatest statistical power to detect differences between carprofen and placebo treatments . defining treatment success as a reduction of @ in pss and @ in pis in each dog had consistently robust power . power was @ % in the population that included only dogs with baseline scores @ and @ % in the population that included only dogs with baseline scores @ . the cbpi had robust statistical power to evaluate the treatment effect of carprofen in dogs with osteoarthritis when protocol success criteria were predefined as a reduction @ in pis and @ in pss . results indicated the cbpi can be used as an outcome measure in clinical trials to evaluate new pain treatments when it is desirable to evaluate success in individual dogs rather than overall mean or median scores in a test population .
24,274,882
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "two once-daily long-acting muscarinic antagonists ( lamas ) are currently available for the treatment of chronic obstructive pulmonary disease ( copd ) - tiotropium and glycopyrronium .", "previous studies have compared glycopyrronium with open-label tiotropium .", "in the glow@ study , we compare glycopyrronium with blinded tiotropium .", "in this blinded , double-dummy , parallel group , @-week study , patients with moderate-to-severe copd were randomized @:@ to glycopyrronium @ g once daily or tiotropium @ g once daily .", "the primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in @ second ( fev@ ) following @ weeks of treatment ( non-inferiority margin : -@ ml ) .", "secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes , breathlessness ( transition dyspnea index ; tdi ) , health status ( st george 's respiratory questionnaire ; sgrq ) , daily rescue medication use , copd exacerbations and copd symptoms over @ weeks of treatment .", "@ patients were randomized ( glycopyrronium : @ ; tiotropium : @ ) ; @ % ( @ patients ) completed the study .", "least squares mean trough fev@ for both glycopyrronium and tiotropium was @ l at week @ , meeting the criterion for non-inferiority ( mean treatment difference : @ ml , @ % ci : -@ , @ ml ) .", "glycopyrronium demonstrated rapid bronchodilation following first dose on day @ , with significantly higher fev@ at all time points from @-@ h post-dose versus tiotropium ( all p < @ ) .", "fev@ area under the curve from @-@ h ( auc@-@h ) post-dose with glycopyrronium was significantly superior to tiotropium on day @ ( p < @ ) and was comparable to tiotropium at week @ .", "glycopyrronium demonstrated comparable improvements to tiotropium in tdi focal score , sgrq total score , rescue medication use and the rate of copd exacerbations ( all p = not significant ) .", "patients on glycopyrronium also had a significantly lower total copd symptom score versus patients on tiotropium after @ weeks ( p = @ ) .", "adverse events were reported by a similar percentage of patients receiving glycopyrronium ( @ % ) and tiotropium ( @ % ) .", "in patients with moderate-to-severe copd , @-week blinded treatment with once-daily glycopyrronium @ g or tiotropium @ g , provided similar efficacy and safety , with glycopyrronium having a faster onset of action on day @ versus tiotropium ." ]
two once-daily long-acting muscarinic antagonists ( lamas ) are currently available for the treatment of chronic obstructive pulmonary disease ( copd ) - tiotropium and glycopyrronium . previous studies have compared glycopyrronium with open-label tiotropium . in the glow@ study , we compare glycopyrronium with blinded tiotropium . in this blinded , double-dummy , parallel group , @-week study , patients with moderate-to-severe copd were randomized @:@ to glycopyrronium @ g once daily or tiotropium @ g once daily . the primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in @ second ( fev@ ) following @ weeks of treatment ( non-inferiority margin : -@ ml ) . secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes , breathlessness ( transition dyspnea index ; tdi ) , health status ( st george 's respiratory questionnaire ; sgrq ) , daily rescue medication use , copd exacerbations and copd symptoms over @ weeks of treatment . @ patients were randomized ( glycopyrronium : @ ; tiotropium : @ ) ; @ % ( @ patients ) completed the study . least squares mean trough fev@ for both glycopyrronium and tiotropium was @ l at week @ , meeting the criterion for non-inferiority ( mean treatment difference : @ ml , @ % ci : -@ , @ ml ) . glycopyrronium demonstrated rapid bronchodilation following first dose on day @ , with significantly higher fev@ at all time points from @-@ h post-dose versus tiotropium ( all p < @ ) . fev@ area under the curve from @-@ h ( auc@-@h ) post-dose with glycopyrronium was significantly superior to tiotropium on day @ ( p < @ ) and was comparable to tiotropium at week @ . glycopyrronium demonstrated comparable improvements to tiotropium in tdi focal score , sgrq total score , rescue medication use and the rate of copd exacerbations ( all p = not significant ) . patients on glycopyrronium also had a significantly lower total copd symptom score versus patients on tiotropium after @ weeks ( p = @ ) . adverse events were reported by a similar percentage of patients receiving glycopyrronium ( @ % ) and tiotropium ( @ % ) . in patients with moderate-to-severe copd , @-week blinded treatment with once-daily glycopyrronium @ g or tiotropium @ g , provided similar efficacy and safety , with glycopyrronium having a faster onset of action on day @ versus tiotropium .
24,438,744
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the potential of lipoprotein-associated phospholipase a@ inhibition as a novel mechanism to reduce edema and improve vision in center-involved diabetic macular edema ( dme ) .", "prospective , multicenter , randomized , double-masked , placebo-controlled phase iia study .", "fifty-four center-involved dme patients randomized @:@ to receive darapladib ( n = @ ) or placebo ( n = @ ) .", "darapladib @ mg or placebo monotherapy was administered orally once daily for @ months , and patients were followed up monthly for @ months .", "mean change from baseline in best-corrected visual acuity ( bcva ) and the center subfield and center point of the study eye at month @ as determined by spectral-domain optical coherence tomography .", "five patients in the study received intravitreal anti-vascular endothelial growth factor rescue therapy before the day @ assessment , @ of @ ( @ % ) in the darapladib arm and @ of @ ( @ % ) in the placebo arm .", "administration of @ mg darapladib for @ months resulted in statistically significant mean improvements , from baseline to month @ , in bcva of @ early treatment diabetic retinopathy study ( etdrs ) letters ( @ % confidence interval -lsb- ci -rsb- , @-@ @ ) and of @ m in central subfield thickness ( @ % ci , -@ to -@ ) in the study eyes .", "an increase in bcva of @ etdrs letters ( @ % ci , -@ to @ ) and a decrease in center subfield thickness of @ m ( @ % ci , -@ to @ ) for the placebo group were not significant .", "no ocular severe adverse events ( saes ) or saes considered related to darapladib were reported .", "one sae of myocardial infarction , not considered related to darapladib , was reported , and @ sae of severe diarrhea was reported in a placebo patient , subsequently withdrawn from the study .", "study eye ocular adverse events ( aes ) and nonocular aes were similar between treatment groups .", "once-daily oral darapladib administered for @ months demonstrated modest improvements in vision and macular edema that warrant additional investigation of this novel lipoprotein-associated phospholipase a@ inhibitory mechanism for the treatment of dme ." ]
to investigate the potential of lipoprotein-associated phospholipase a@ inhibition as a novel mechanism to reduce edema and improve vision in center-involved diabetic macular edema ( dme ) . prospective , multicenter , randomized , double-masked , placebo-controlled phase iia study . fifty-four center-involved dme patients randomized @:@ to receive darapladib ( n = @ ) or placebo ( n = @ ) . darapladib @ mg or placebo monotherapy was administered orally once daily for @ months , and patients were followed up monthly for @ months . mean change from baseline in best-corrected visual acuity ( bcva ) and the center subfield and center point of the study eye at month @ as determined by spectral-domain optical coherence tomography . five patients in the study received intravitreal anti-vascular endothelial growth factor rescue therapy before the day @ assessment , @ of @ ( @ % ) in the darapladib arm and @ of @ ( @ % ) in the placebo arm . administration of @ mg darapladib for @ months resulted in statistically significant mean improvements , from baseline to month @ , in bcva of @ early treatment diabetic retinopathy study ( etdrs ) letters ( @ % confidence interval -lsb- ci -rsb- , @-@ @ ) and of @ m in central subfield thickness ( @ % ci , -@ to -@ ) in the study eyes . an increase in bcva of @ etdrs letters ( @ % ci , -@ to @ ) and a decrease in center subfield thickness of @ m ( @ % ci , -@ to @ ) for the placebo group were not significant . no ocular severe adverse events ( saes ) or saes considered related to darapladib were reported . one sae of myocardial infarction , not considered related to darapladib , was reported , and @ sae of severe diarrhea was reported in a placebo patient , subsequently withdrawn from the study . study eye ocular adverse events ( aes ) and nonocular aes were similar between treatment groups . once-daily oral darapladib administered for @ months demonstrated modest improvements in vision and macular edema that warrant additional investigation of this novel lipoprotein-associated phospholipase a@ inhibitory mechanism for the treatment of dme .
25,749,297
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to characterize retinal metabolism during normoxia and hyperoxia in healthy subjects .", "forty-six healthy subjects were included in the present study , and data of @ subjects could be evaluated .", "retinal vessel diameters , as well as oxygen saturation in arteries and veins , were measured using the dynamic vessel analyzer .", "in addition , retinal venous blood velocity was measured using bidirectional laser doppler velocimetry , retinal blood flow was calculated , and oxygen and carbon dioxide partial pressures were measured from arterialized capillary blood from the earlobe .", "measurements were done during normoxia and during @ % oxygen breathing .", "systemic hyperoxia caused a significant decrease in retinal venous diameter ( -@ % @ % ) and arterial diameter ( -@ % @ % ) , in retinal blood velocity ( -@ % @ % ) , and in retinal blood flow ( -@ % @ % ) ( p < @ for all ) .", "oxygen saturation increased in retinal arteries ( +@ % @ % ) and in retinal veins ( +@ % @ % ) , but the arteriovenous oxygen content difference significantly decreased ( -@ % @ % ) ( p < @ for all ) .", "blood oxygen tension in arterialized blood showed a pronounced increase from @ @ to @ @ mm hg ( p < @ ) .", "calculated oxygen extraction in the eye decreased by as much as @ % @ % ( p < @ ) .", "our data are compatible with the hypothesis that during @ % oxygen breathing a large amount of oxygen , consumed by the inner retina , comes from the choroid , which is supported by previous animal data .", "interpretation of oxygen saturation data in retinal arteries and veins without quantifying blood flow is difficult .", "( clinicaltrials.gov number , nct@ . )" ]
to characterize retinal metabolism during normoxia and hyperoxia in healthy subjects . forty-six healthy subjects were included in the present study , and data of @ subjects could be evaluated . retinal vessel diameters , as well as oxygen saturation in arteries and veins , were measured using the dynamic vessel analyzer . in addition , retinal venous blood velocity was measured using bidirectional laser doppler velocimetry , retinal blood flow was calculated , and oxygen and carbon dioxide partial pressures were measured from arterialized capillary blood from the earlobe . measurements were done during normoxia and during @ % oxygen breathing . systemic hyperoxia caused a significant decrease in retinal venous diameter ( -@ % @ % ) and arterial diameter ( -@ % @ % ) , in retinal blood velocity ( -@ % @ % ) , and in retinal blood flow ( -@ % @ % ) ( p < @ for all ) . oxygen saturation increased in retinal arteries ( +@ % @ % ) and in retinal veins ( +@ % @ % ) , but the arteriovenous oxygen content difference significantly decreased ( -@ % @ % ) ( p < @ for all ) . blood oxygen tension in arterialized blood showed a pronounced increase from @ @ to @ @ mm hg ( p < @ ) . calculated oxygen extraction in the eye decreased by as much as @ % @ % ( p < @ ) . our data are compatible with the hypothesis that during @ % oxygen breathing a large amount of oxygen , consumed by the inner retina , comes from the choroid , which is supported by previous animal data . interpretation of oxygen saturation data in retinal arteries and veins without quantifying blood flow is difficult . ( clinicaltrials.gov number , nct@ . )
25,015,353
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "young people in sub-saharan africa are affected by the hiv pandemic to a greater extent than young people elsewhere and effective hiv-preventive intervention programmes are urgently needed .", "the present article presents the rationale behind an eu-funded research project ( prepare ) examining effects of community-based ( school delivered ) interventions conducted in four sites in sub-saharan africa .", "one intervention focuses on changing beliefs and cognitions related to sexual practices ( mankweng , limpopo , south africa ) .", "another promotes improved parent-offspring communication on sexuality ( kampala , uganda ) .", "two further interventions are more comprehensive aiming to promote healthy sexual practices .", "one of these ( western cape , south africa ) also aims to reduce intimate partner violence while the other ( dar es salaam , tanzania ) utilises school-based peer education .", "a modified intervention mapping approach is used to develop all programmes .", "cluster randomised controlled trials of programmes delivered to school students aged @-@ will be conducted in each study site .", "schools will be randomly allocated ( after matching or stratification ) to intervention and delayed intervention arms .", "baseline surveys at each site are followed by interventions and then by one ( kampala and limpopo ) or two ( western cape and dar es salaam ) post-intervention data collections .", "questionnaires include questions common for all sites and are partly based on a set of social cognition models previously applied to the study of hiv-preventive behaviours .", "data from all sites will be merged in order to compare prevalence and associations across sites on core variables .", "power is set to @ or higher and significance level to @ or lower in order to detect intervention effects .", "intraclass correlations will be estimated from previous surveys carried out at each site .", "we expect prepare interventions to have an impact on hypothesized determinants of risky sexual behaviour and in western cape and dar es salaam to change sexual practices .", "results from prepare will ( i ) identify modifiable cognitions and social processes related to risky sexual behaviour and ( ii ) identify promising intervention approaches among young adolescents in sub-saharan cultures and contexts .", "controlled trials isrctn@ ( cape town ) ; controlled trials isrctn@ ( limpopo ) ; clinical trials nct@ ( kampala ) ; australian new zealand clinical trials registry actrn@ ( dar es salaam ) ." ]
young people in sub-saharan africa are affected by the hiv pandemic to a greater extent than young people elsewhere and effective hiv-preventive intervention programmes are urgently needed . the present article presents the rationale behind an eu-funded research project ( prepare ) examining effects of community-based ( school delivered ) interventions conducted in four sites in sub-saharan africa . one intervention focuses on changing beliefs and cognitions related to sexual practices ( mankweng , limpopo , south africa ) . another promotes improved parent-offspring communication on sexuality ( kampala , uganda ) . two further interventions are more comprehensive aiming to promote healthy sexual practices . one of these ( western cape , south africa ) also aims to reduce intimate partner violence while the other ( dar es salaam , tanzania ) utilises school-based peer education . a modified intervention mapping approach is used to develop all programmes . cluster randomised controlled trials of programmes delivered to school students aged @-@ will be conducted in each study site . schools will be randomly allocated ( after matching or stratification ) to intervention and delayed intervention arms . baseline surveys at each site are followed by interventions and then by one ( kampala and limpopo ) or two ( western cape and dar es salaam ) post-intervention data collections . questionnaires include questions common for all sites and are partly based on a set of social cognition models previously applied to the study of hiv-preventive behaviours . data from all sites will be merged in order to compare prevalence and associations across sites on core variables . power is set to @ or higher and significance level to @ or lower in order to detect intervention effects . intraclass correlations will be estimated from previous surveys carried out at each site . we expect prepare interventions to have an impact on hypothesized determinants of risky sexual behaviour and in western cape and dar es salaam to change sexual practices . results from prepare will ( i ) identify modifiable cognitions and social processes related to risky sexual behaviour and ( ii ) identify promising intervention approaches among young adolescents in sub-saharan cultures and contexts . controlled trials isrctn@ ( cape town ) ; controlled trials isrctn@ ( limpopo ) ; clinical trials nct@ ( kampala ) ; australian new zealand clinical trials registry actrn@ ( dar es salaam ) .
24,438,582
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "though topical corticosteroids ( tc ) are used for treating atopic dermatitis ( ad ) as a standard , there exist several problems including topical steroid addiction ( tsa ) or red skin syndrome .", "moreover , the number of patients , who refrain from using tc because of steroid-phobia , is increasing .", "recently , topical ppar alpha ligand application has been reported to improve experimental allergic dermatitis .", "the purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate , one of ppar alpha ligand , in such steroid-phobic patients with ad .", "this study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base ( placebo ) on skin manifestation and blood parameters of patients for @ weeks .", "severity was digitized using severity scoring systems for atopic dermatitis by the japanese dermatological association ( sss-jda ) before and after two weeks .", "subjective severity of patients was evaluated using visual analog scale ( pt-vas ) .", "serum thymus and activation-regulated chemokine ( tarc ) and immunoglobulin e ( ige ) were also investigated .", "twenty patients were enrolled , and @ of @ patients completed the study .", "in @ patients , the value of severity score using sss-jda was decreased significantly after administration of topical clofibrate ( p = @ ) .", "subjective evaluation using pt-vas ( p = @ ) and serum tarc levels ( p = @ ) were also significantly decreased after two weeks of topical clofibrate .", "there was not a significant difference in serum ige levels .", "no adverse effect was observed .", "topical clofibrate is useful for patients with ad especially who are reluctant to use topical steroids ." ]
though topical corticosteroids ( tc ) are used for treating atopic dermatitis ( ad ) as a standard , there exist several problems including topical steroid addiction ( tsa ) or red skin syndrome . moreover , the number of patients , who refrain from using tc because of steroid-phobia , is increasing . recently , topical ppar alpha ligand application has been reported to improve experimental allergic dermatitis . the purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate , one of ppar alpha ligand , in such steroid-phobic patients with ad . this study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base ( placebo ) on skin manifestation and blood parameters of patients for @ weeks . severity was digitized using severity scoring systems for atopic dermatitis by the japanese dermatological association ( sss-jda ) before and after two weeks . subjective severity of patients was evaluated using visual analog scale ( pt-vas ) . serum thymus and activation-regulated chemokine ( tarc ) and immunoglobulin e ( ige ) were also investigated . twenty patients were enrolled , and @ of @ patients completed the study . in @ patients , the value of severity score using sss-jda was decreased significantly after administration of topical clofibrate ( p = @ ) . subjective evaluation using pt-vas ( p = @ ) and serum tarc levels ( p = @ ) were also significantly decreased after two weeks of topical clofibrate . there was not a significant difference in serum ige levels . no adverse effect was observed . topical clofibrate is useful for patients with ad especially who are reluctant to use topical steroids .
24,595,568
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the effects of single doses of gabapentin @ and @ mg on polysomnographic ( psg ) and participant-reported sleep measures in a @-h phase advance insomnia model .", "adults reporting occasional disturbed sleep received gabapentin @ mg ( n = @ ) , @ mg ( n = @ ) , or placebo ( n = @ ) @ min prior to bedtime and were in bed from @:@ to @:@ , @ h before their habitual bedtime .", "sleep was assessed by psg , post-sleep questionnaire , and the karolinska sleep diary ( ksd ) .", "next-day residual effects ( digit symbol substitution test -lsb- dsst -rsb- and stanford sleepiness scale -lsb- sss -rsb- ) and tolerability were assessed .", "demographics were comparable among groups .", "among psg endpoints , wake after sleep onset ( primary endpoint ) ( @ -lsb- placebo -rsb- , @ -lsb- @ mg -rsb- , and @ -lsb- @ mg -rsb- min ) was significantly lower and total sleep time ( tst ) ( @ , @ , and @ min ) significantly greater in both gabapentin groups versus placebo .", "latency to persistent sleep was not significantly different among groups .", "percent slow wave sleep ( @ % , @ % , and @ % , respectively ) was significantly greater and percent stage @ ( @ % , @ % , and @ % , respectively ) significantly lower relative to placebo .", "gabapentin was associated with significantly higher values of ksd sleep quality index and reported tst versus placebo ; no other reported outcomes were significant .", "neither gabapentin dose produced evidence of next-day residual effects as measured by dsst and sss .", "adverse events were infrequent ( < @ % ) .", "participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth ( versus placebo ) in response to a phase advance manipulation known to disrupt sleep maintenance ." ]
to evaluate the effects of single doses of gabapentin @ and @ mg on polysomnographic ( psg ) and participant-reported sleep measures in a @-h phase advance insomnia model . adults reporting occasional disturbed sleep received gabapentin @ mg ( n = @ ) , @ mg ( n = @ ) , or placebo ( n = @ ) @ min prior to bedtime and were in bed from @:@ to @:@ , @ h before their habitual bedtime . sleep was assessed by psg , post-sleep questionnaire , and the karolinska sleep diary ( ksd ) . next-day residual effects ( digit symbol substitution test -lsb- dsst -rsb- and stanford sleepiness scale -lsb- sss -rsb- ) and tolerability were assessed . demographics were comparable among groups . among psg endpoints , wake after sleep onset ( primary endpoint ) ( @ -lsb- placebo -rsb- , @ -lsb- @ mg -rsb- , and @ -lsb- @ mg -rsb- min ) was significantly lower and total sleep time ( tst ) ( @ , @ , and @ min ) significantly greater in both gabapentin groups versus placebo . latency to persistent sleep was not significantly different among groups . percent slow wave sleep ( @ % , @ % , and @ % , respectively ) was significantly greater and percent stage @ ( @ % , @ % , and @ % , respectively ) significantly lower relative to placebo . gabapentin was associated with significantly higher values of ksd sleep quality index and reported tst versus placebo ; no other reported outcomes were significant . neither gabapentin dose produced evidence of next-day residual effects as measured by dsst and sss . adverse events were infrequent ( < @ % ) . participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth ( versus placebo ) in response to a phase advance manipulation known to disrupt sleep maintenance .
25,317,090
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of this study is to evaluate the clinical efficacy of short-term psychodynamic psychotherapy ( stpp ) in comparison with treatment as usual ( tau ) in treatment of patients suffering from anxiety and depressive disorders .", "sixty patients were recruited from the psychotherapy service , university of milan , department of psychiatry , at milan 's irccs foundation ca ' granda , ospedale maggiore policlinico with the diagnosis of depressive or anxiety disorders according to dsm-iv-tr criteria .", "these subjects were randomly assigned in a @:@ ratio to an intervention group ( stpp ) or control group ( tau ) for @ months ( t@ ) .", "each patient was clinically evaluated at the moment of recruitment ( t@ ) and after @ months using a battery composed of these scales : clinical global impression scale ( cgi ) , symptom checklist-@-revised ( scl-@-r ) , inventory of interpersonal problems ( iip ) .", "statistical analysis highlighted significant improvements ( p < @ ) for the group treated with stpp in every clinical scale .", "instead control group revealed significant changes ( p < @ ) only for scl-@ scale scores .", "we noticed a clinical improvement in both groups without particular differences , but the iip scores went through a significant higher enhancement only in stpp group .", "our results suggest that stpp is so effective as tau in treatment of anxiety and depressive disorders .", "moreover stpp leads to a better recover of relational functioning ." ]
the aim of this study is to evaluate the clinical efficacy of short-term psychodynamic psychotherapy ( stpp ) in comparison with treatment as usual ( tau ) in treatment of patients suffering from anxiety and depressive disorders . sixty patients were recruited from the psychotherapy service , university of milan , department of psychiatry , at milan 's irccs foundation ca ' granda , ospedale maggiore policlinico with the diagnosis of depressive or anxiety disorders according to dsm-iv-tr criteria . these subjects were randomly assigned in a @:@ ratio to an intervention group ( stpp ) or control group ( tau ) for @ months ( t@ ) . each patient was clinically evaluated at the moment of recruitment ( t@ ) and after @ months using a battery composed of these scales : clinical global impression scale ( cgi ) , symptom checklist-@-revised ( scl-@-r ) , inventory of interpersonal problems ( iip ) . statistical analysis highlighted significant improvements ( p < @ ) for the group treated with stpp in every clinical scale . instead control group revealed significant changes ( p < @ ) only for scl-@ scale scores . we noticed a clinical improvement in both groups without particular differences , but the iip scores went through a significant higher enhancement only in stpp group . our results suggest that stpp is so effective as tau in treatment of anxiety and depressive disorders . moreover stpp leads to a better recover of relational functioning .
24,572,581
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "carotid artery stenting ( cas ) is a worldwide diffuse intervention , but may be associated with distal plaque component embolization , and sometimes major and minor stroke .", "statin use has been demonstrated to reduce atherosclerotic plaque burden , but its effect in reducing distal embolization during carotid stenting has not yet been well validated .", "with the rosuvastatin pretreatment to reduce embolization during carotid artery stenting trial , we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting .", "this is a phase iii prospective , randomized controlled trial .", "all consecutive patients with asymptomatic carotid stenosis at least @ % will be randomized to a @-week rosuvastatin treatment followed by carotid stenting , and to direct carotid stenting .", "carotid stenting will be performed following common practice with distal or proximal embolic protection .", "the primary efficacy end point of the trial will be the prevalence of ` relevant ' embolization during cas , as a surrogate end point for cerebral ischemic complications .", "other laboratory and clinical data will be registered and patients will be followed up to @ year .", "in order to obtain the expected superiority of statin pretreatment on primary end point , a population of @ patients will be enrolled into the study .", "in conclusion , with the rosuvastatin pretreatment to reduce embolization during carotid artery stenting trial , we want to evaluate whether a high dose of rosuvastatin for @ weeks before cas in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure , thus suggesting a possible reduction in cerebral ischemic complications ." ]
carotid artery stenting ( cas ) is a worldwide diffuse intervention , but may be associated with distal plaque component embolization , and sometimes major and minor stroke . statin use has been demonstrated to reduce atherosclerotic plaque burden , but its effect in reducing distal embolization during carotid stenting has not yet been well validated . with the rosuvastatin pretreatment to reduce embolization during carotid artery stenting trial , we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting . this is a phase iii prospective , randomized controlled trial . all consecutive patients with asymptomatic carotid stenosis at least @ % will be randomized to a @-week rosuvastatin treatment followed by carotid stenting , and to direct carotid stenting . carotid stenting will be performed following common practice with distal or proximal embolic protection . the primary efficacy end point of the trial will be the prevalence of ` relevant ' embolization during cas , as a surrogate end point for cerebral ischemic complications . other laboratory and clinical data will be registered and patients will be followed up to @ year . in order to obtain the expected superiority of statin pretreatment on primary end point , a population of @ patients will be enrolled into the study . in conclusion , with the rosuvastatin pretreatment to reduce embolization during carotid artery stenting trial , we want to evaluate whether a high dose of rosuvastatin for @ weeks before cas in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure , thus suggesting a possible reduction in cerebral ischemic complications .
24,922,046
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]
[ "among the various factors influencing the success rate , onset time , and duration of peripheral nerve blocks , the role of local anesthetics concentration remains uncertain .", "in this prospective , randomized , single-blinded study , we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block .", "ninety asa physical status i to ii patients scheduled for foot surgery were randomly allocated to receive a double-injection labat sciatic nerve block with @ ml mepivacaine @ % ( group concentration i = @ patients ) or @ ml of mepivacaine @ % ( group volume ii = @ patients ) .", "the nerve stimulator was initially set at @ hz , @ millisecond , @ ma .", "the total amount of local anesthetic ( @ mg ) was kept constant and equally divided between the peroneal and tibial nerves .", "all patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia .", "times to readiness for surgery , performance , and offset of local anesthetic were recorded .", "our primary end point was to determine a possible difference in offset time between groups .", "continuous variables were expressed as median ( iqr ) and compared with the wilcoxon-mann-whitney u test ; wmwodds are reported together with their @ % confidence interval .", "the overall success rate of sciatic nerve block was @ % .", "time of performance was shorter in group i , @ seconds ( @-@ seconds ) , than that in group ii , @ seconds ( @-@ seconds ) ( p = @ ; wmwodds @ -lsb- @-@ @ -rsb- ) .", "the onset time of sensory and motor sciatic nerve block was @ minutes ( @-@ minutes ) in group i and @ minutes ( @-@ minutes ) in group ii ( p = @ ; wmwodds @ -lsb- @-@ @ -rsb- ) , while the duration of sensory block was @ minutes ( @-@ minutes ) in group i , and @ minutes ( @-@ minutes ) in group ii respectively ( p = @ ; wmwodds @ -lsb- @-@ @ -rsb- ) .", "we found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block .", "considering our wmwodds results , possible differences in onset time and duration comparable to differences in the performance time between groups can not be excluded ." ]
among the various factors influencing the success rate , onset time , and duration of peripheral nerve blocks , the role of local anesthetics concentration remains uncertain . in this prospective , randomized , single-blinded study , we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block . ninety asa physical status i to ii patients scheduled for foot surgery were randomly allocated to receive a double-injection labat sciatic nerve block with @ ml mepivacaine @ % ( group concentration i = @ patients ) or @ ml of mepivacaine @ % ( group volume ii = @ patients ) . the nerve stimulator was initially set at @ hz , @ millisecond , @ ma . the total amount of local anesthetic ( @ mg ) was kept constant and equally divided between the peroneal and tibial nerves . all patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia . times to readiness for surgery , performance , and offset of local anesthetic were recorded . our primary end point was to determine a possible difference in offset time between groups . continuous variables were expressed as median ( iqr ) and compared with the wilcoxon-mann-whitney u test ; wmwodds are reported together with their @ % confidence interval . the overall success rate of sciatic nerve block was @ % . time of performance was shorter in group i , @ seconds ( @-@ seconds ) , than that in group ii , @ seconds ( @-@ seconds ) ( p = @ ; wmwodds @ -lsb- @-@ @ -rsb- ) . the onset time of sensory and motor sciatic nerve block was @ minutes ( @-@ minutes ) in group i and @ minutes ( @-@ minutes ) in group ii ( p = @ ; wmwodds @ -lsb- @-@ @ -rsb- ) , while the duration of sensory block was @ minutes ( @-@ minutes ) in group i , and @ minutes ( @-@ minutes ) in group ii respectively ( p = @ ; wmwodds @ -lsb- @-@ @ -rsb- ) . we found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block . considering our wmwodds results , possible differences in onset time and duration comparable to differences in the performance time between groups can not be excluded .
24,914,630
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the effects of thai traditional massage ( ttm ) on pressure pain threshold ( ppt ) and headache intensity in patients with chronic tension-type and migraine headaches .", "randomized controlled trial of ttm compared with the sham ultrasound ( nine sessions each ) during a @-week period .", "seventy-two participants who had had a headache diagnosis for at least @ months before the experiment was recruited .", "after the treatment and at @ and @ weeks of follow-up , the ttm group showed a significant increase in ppt ( p < @ ) compared with the sham ultrasound group .", "ppt values at baseline , after @ weeks of treatment , and at @ - and @-week follow-up for the ttm group were @ @ , @ @ , @ @ , and @ @ pounds/cm ( @ ) , respectively ; values in the sham ultrasound group were @ @ , @ @ , @ @ and @ @ pounds/cm ( @ ) .", "in both groups , headache intensity decreased significantly ( p < @ ) at every end point of the outcome measures , and there were no differences between the groups ( p > @ ) .", "ttm could increase ppt and reduce headache intensity , suggesting that this is a possible alternative treatment for chronic headaches ." ]
to investigate the effects of thai traditional massage ( ttm ) on pressure pain threshold ( ppt ) and headache intensity in patients with chronic tension-type and migraine headaches . randomized controlled trial of ttm compared with the sham ultrasound ( nine sessions each ) during a @-week period . seventy-two participants who had had a headache diagnosis for at least @ months before the experiment was recruited . after the treatment and at @ and @ weeks of follow-up , the ttm group showed a significant increase in ppt ( p < @ ) compared with the sham ultrasound group . ppt values at baseline , after @ weeks of treatment , and at @ - and @-week follow-up for the ttm group were @ @ , @ @ , @ @ , and @ @ pounds/cm ( @ ) , respectively ; values in the sham ultrasound group were @ @ , @ @ , @ @ and @ @ pounds/cm ( @ ) . in both groups , headache intensity decreased significantly ( p < @ ) at every end point of the outcome measures , and there were no differences between the groups ( p > @ ) . ttm could increase ppt and reduce headache intensity , suggesting that this is a possible alternative treatment for chronic headaches .
24,738,648
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the usefulness of capnography for early detection of respiratory depression during sedoanalgesia procedures in the pediatric emergency department .", "to assess whether the administration of oxygen during the procedure can modify monitored parameters , thus delaying detection of respiratory depression .", "a prospective randomized study was performed on children between @ year and @ years who underwent sedoanalgesia to perform diagnostic or therapeutic procedures .", "they were randomized into two groups ( with or without supplemental oxygen ) .", "all patients were monitored by visual inspection , pulse-oximetry and non-invasive capnography .", "monitoring was initiated prior to drug administration and continued until complete recovery of baseline .", "the main study variable was respiratory depression defined as apnea , hypoventilation or oxygen desaturation .", "twenty patients were included .", "eleven patients were randomized in the supplemental oxygen group .", "this study showed a statistically significant elevation of etco@ levels at @ , @ and @min , compared with baseline .", "no significant change in the sato@ mean was detected .", "no statistically significant differences were identified when comparing etco@ mean and sato@ mean in both groups .", "two cases of respiratory depression were detected early by capnography .", "there was a statistically significant correlation between etco@ at @ and @min , and the degree of sedation achieved .", "the inclusion of capnography to routine monitoring for adequate sedation procedures could improve safety .", "oxygen administration does not appear to modify the parameters monitored ." ]
to evaluate the usefulness of capnography for early detection of respiratory depression during sedoanalgesia procedures in the pediatric emergency department . to assess whether the administration of oxygen during the procedure can modify monitored parameters , thus delaying detection of respiratory depression . a prospective randomized study was performed on children between @ year and @ years who underwent sedoanalgesia to perform diagnostic or therapeutic procedures . they were randomized into two groups ( with or without supplemental oxygen ) . all patients were monitored by visual inspection , pulse-oximetry and non-invasive capnography . monitoring was initiated prior to drug administration and continued until complete recovery of baseline . the main study variable was respiratory depression defined as apnea , hypoventilation or oxygen desaturation . twenty patients were included . eleven patients were randomized in the supplemental oxygen group . this study showed a statistically significant elevation of etco@ levels at @ , @ and @min , compared with baseline . no significant change in the sato@ mean was detected . no statistically significant differences were identified when comparing etco@ mean and sato@ mean in both groups . two cases of respiratory depression were detected early by capnography . there was a statistically significant correlation between etco@ at @ and @min , and the degree of sedation achieved . the inclusion of capnography to routine monitoring for adequate sedation procedures could improve safety . oxygen administration does not appear to modify the parameters monitored .
24,269,547
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "glycemic index and glycemic load are used to facilitate glucose control among adults with type @ diabetes , with a low glycemic index diet associated with improved glycemic control .", "to examine long-term longitudinal associations between changes in glycemic index and glycemic load with glycemic and metabolic control among latino adults with diabetes .", "secondary data from intervention and comparison participants in the latinos en control trial ( @ to @ ) were analyzed .", "data on dietary intake and metabolic characteristics were from low-income , latino adults ( n = @ ; @ % puerto rican ) with type @ diabetes .", "the latinos en control trial was a randomized clinical trial targeting diabetes self-management among latinos with type @ diabetes .", "participants were randomized to a group-based behavioral intervention or usual care and followed through @ months .", "outcomes included hemoglobin a@c ( hba@c ) levels , fasting blood glucose , lipid profiles , anthropometrics , and blood pressure .", "glycemic index and load were analyzed using data from three @-hour dietary recalls conducted at baseline , @ months , and @ months .", "repeated measures regression models were used to examine change in glycemic index and load associated with metabolic characteristics at @ months .", "covariates included sex , age , body mass index , blood pressure , total energy intake , medication use and intensity , physical activity , intervention status ( intervention vs usual care ) , and time .", "increases in glycemic index from baseline to @ months were associated with increased logarithm of hba@c levels ( = @ ; p = @ ) and waist circumference ( = @ ; p = @ ) over time , but not with fasting glucose , blood lipids , or body mass index .", "there was modest evidence to support small , positive associations between glycemic load and hba@c levels and waist circumference .", "lowering glycemic index is associated with improvements in certain metabolic risk factors among latinos with diabetes .", "targeting glycemic index may be an important component of dietary strategies for diabetes self-management ." ]
glycemic index and glycemic load are used to facilitate glucose control among adults with type @ diabetes , with a low glycemic index diet associated with improved glycemic control . to examine long-term longitudinal associations between changes in glycemic index and glycemic load with glycemic and metabolic control among latino adults with diabetes . secondary data from intervention and comparison participants in the latinos en control trial ( @ to @ ) were analyzed . data on dietary intake and metabolic characteristics were from low-income , latino adults ( n = @ ; @ % puerto rican ) with type @ diabetes . the latinos en control trial was a randomized clinical trial targeting diabetes self-management among latinos with type @ diabetes . participants were randomized to a group-based behavioral intervention or usual care and followed through @ months . outcomes included hemoglobin a@c ( hba@c ) levels , fasting blood glucose , lipid profiles , anthropometrics , and blood pressure . glycemic index and load were analyzed using data from three @-hour dietary recalls conducted at baseline , @ months , and @ months . repeated measures regression models were used to examine change in glycemic index and load associated with metabolic characteristics at @ months . covariates included sex , age , body mass index , blood pressure , total energy intake , medication use and intensity , physical activity , intervention status ( intervention vs usual care ) , and time . increases in glycemic index from baseline to @ months were associated with increased logarithm of hba@c levels ( = @ ; p = @ ) and waist circumference ( = @ ; p = @ ) over time , but not with fasting glucose , blood lipids , or body mass index . there was modest evidence to support small , positive associations between glycemic load and hba@c levels and waist circumference . lowering glycemic index is associated with improvements in certain metabolic risk factors among latinos with diabetes . targeting glycemic index may be an important component of dietary strategies for diabetes self-management .
25,547,339
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to test whether communicating cardiovascular diseases ( cvd ) risk using a novel risk assessment tool ( heart age ) will be able to motivate a population to adopt healthier lifestyles and improve cvd risk profile over the use of a traditional percentage-based tool .", "a single-blind randomized intervention study was carried out in a caucasian population .", "a total of @ subjects were randomly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , framingham regicor ( @-year percentage risk score , calibrated to spanish population was given to the subjects ) , or heart age group ( heart age tool was administered to the subjects ) .", "anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and @-months post intervention .", "both the framingham regicor and the heart age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the heart age group .", "no differences per gender were observed in the heart age group .", "informing patients about their cvd risk expressed as the new heart age tool results in a reduction in their cvd risk higher than the one observed when the framingham regicor risk score was used ." ]
to test whether communicating cardiovascular diseases ( cvd ) risk using a novel risk assessment tool ( heart age ) will be able to motivate a population to adopt healthier lifestyles and improve cvd risk profile over the use of a traditional percentage-based tool . a single-blind randomized intervention study was carried out in a caucasian population . a total of @ subjects were randomly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , framingham regicor ( @-year percentage risk score , calibrated to spanish population was given to the subjects ) , or heart age group ( heart age tool was administered to the subjects ) . anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and @-months post intervention . both the framingham regicor and the heart age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the heart age group . no differences per gender were observed in the heart age group . informing patients about their cvd risk expressed as the new heart age tool results in a reduction in their cvd risk higher than the one observed when the framingham regicor risk score was used .
24,491,403
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "tonsillectomy is one of the most common pediatric surgical procedures performed in the united states .", "the postoperative period can be particularly painful , and there is currently no consensus on an optimal analgesic regimen .", "the objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy .", "prospective , double-blinded , randomized controlled trial .", "large , midwestern us pediatric hospital .", "eighty-four children aged @-@ years who underwent a tonsillectomy ( with or without adenoidectomy ) procedure were randomized and @ were included in the analysis .", "group @ received liquid codeine/acetaminophen for @ days post-tonsillectomy ( @ days scheduled , followed by @ days as-needed ) .", "group @ received liquid tramadol for @ days post-tonsillectomy ( @ days scheduled , followed by @ days as-needed ) .", "efficacy and side effects were evaluated using a @-day take-home diary that was completed by parents .", "children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores .", "oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group , and itching was experienced by significantly more children in the tramadol group during the postoperative period .", "as part of multimodal analgesia , scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties , low potential for side effects , and good safety profile ." ]
tonsillectomy is one of the most common pediatric surgical procedures performed in the united states . the postoperative period can be particularly painful , and there is currently no consensus on an optimal analgesic regimen . the objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy . prospective , double-blinded , randomized controlled trial . large , midwestern us pediatric hospital . eighty-four children aged @-@ years who underwent a tonsillectomy ( with or without adenoidectomy ) procedure were randomized and @ were included in the analysis . group @ received liquid codeine/acetaminophen for @ days post-tonsillectomy ( @ days scheduled , followed by @ days as-needed ) . group @ received liquid tramadol for @ days post-tonsillectomy ( @ days scheduled , followed by @ days as-needed ) . efficacy and side effects were evaluated using a @-day take-home diary that was completed by parents . children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores . oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group , and itching was experienced by significantly more children in the tramadol group during the postoperative period . as part of multimodal analgesia , scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties , low potential for side effects , and good safety profile .
26,312,955
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "thirty-six months of isoniazid preventive therapy ( @ipt ) was superior to @ months of ipt ( @ipt ) in preventing tuberculosis ( tb ) among hiv-infected adults in botswana .", "we assessed the posttrial durability of this benefit .", "a @-month double-blind placebo controlled trial ( @:@ randomization ) with recruitment between november @ and july @ and observation until june @ .", "one thousand , nine hundred and ninety-five participants were followed in eight public health clinics .", "twenty-four percent had a tuberculin skin test @mm ( tst-positive ) .", "a minimum cd@ lymphocyte count was not required for enrolment .", "antiretroviral therapy ( art ) was provided in accordance with botswana guidelines ; @ % of participants retained by june @ had initiated art .", "multivariable analysis using cox regression analysis included treatment arm , tst status , art as a time-dependent variable and cd@ cell count at baseline and updated at @ months .", "in the posttrial period , @ and @ per @ person-years accumulated , whereas @ and @ % tb incidence rates were observed in the @ipt and @ipt arms , respectively ( p = @ ) .", "the crude hazard ratio of tb during the trial and posttrial was @ -lsb- @ % confidence intervals ( ci ) @ , @ -rsb- and @ ( @ % ci @ , @ ) , and when restricted to tst-positive participants was @ ( @ % ci @ , @ ) and @ ( @ % ci @ , @ ) , respectively .", "multivariable analysis showed that art use was associated with reduced death ( adjusted hazard ratio @ , @ % ci @-@ @ ) but not tb ( @ , @ % ci @-@ @ ) in the posttrial period .", "the benefit of @ipt for tb prevention declined posttrial in this cohort .", "adjunctive measures are warranted to prevent tb among hiv-infected persons receiving long-term art in tb-endemic settings ." ]
thirty-six months of isoniazid preventive therapy ( @ipt ) was superior to @ months of ipt ( @ipt ) in preventing tuberculosis ( tb ) among hiv-infected adults in botswana . we assessed the posttrial durability of this benefit . a @-month double-blind placebo controlled trial ( @:@ randomization ) with recruitment between november @ and july @ and observation until june @ . one thousand , nine hundred and ninety-five participants were followed in eight public health clinics . twenty-four percent had a tuberculin skin test @mm ( tst-positive ) . a minimum cd@ lymphocyte count was not required for enrolment . antiretroviral therapy ( art ) was provided in accordance with botswana guidelines ; @ % of participants retained by june @ had initiated art . multivariable analysis using cox regression analysis included treatment arm , tst status , art as a time-dependent variable and cd@ cell count at baseline and updated at @ months . in the posttrial period , @ and @ per @ person-years accumulated , whereas @ and @ % tb incidence rates were observed in the @ipt and @ipt arms , respectively ( p = @ ) . the crude hazard ratio of tb during the trial and posttrial was @ -lsb- @ % confidence intervals ( ci ) @ , @ -rsb- and @ ( @ % ci @ , @ ) , and when restricted to tst-positive participants was @ ( @ % ci @ , @ ) and @ ( @ % ci @ , @ ) , respectively . multivariable analysis showed that art use was associated with reduced death ( adjusted hazard ratio @ , @ % ci @-@ @ ) but not tb ( @ , @ % ci @-@ @ ) in the posttrial period . the benefit of @ipt for tb prevention declined posttrial in this cohort . adjunctive measures are warranted to prevent tb among hiv-infected persons receiving long-term art in tb-endemic settings .
25,686,683
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the short-term efficacy and safety of methoxyflurane for the treatment of acute pain in patients presenting to an emergency department ( ed ) with minor trauma .", "stop !", "was a randomised , double-blind , multicentre , placebo-controlled study conducted at six sites in the uk .", "a total of @ patients , @ of whom were adolescent patients ( age @-@ years ) , were randomised @:@ to receive either methoxyflurane via a penthrox inhaler or placebo .", "the primary end point of the study was the change in pain intensity as measured using the visual analogue scale ( vas ) from baseline to @ , @ , @ and @ min after the start of study drug inhalation .", "patients were supplied with one inhaler containing @ ml methoxyflurane or @ ml placebo after enrolment and initial assessments .", "age group ( adolescent/adult ) and baseline vas score were controlled for in the statistical analyses .", "a total of @ patients received methoxyflurane , and @ patients received placebo .", "demographic and baseline characteristics were comparable between the groups .", "methoxyflurane reduced pain severity significantly more than placebo ( p < @ ) at all time points tested , with the greatest estimated treatment effect of -@ mm ( adjusted change from baseline ) seen at @ min after the start of treatment .", "methoxyflurane was well tolerated , with the majority of adverse reactions being mild , transient and in line with anticipated pharmacological action .", "the results of this study suggest that methoxyflurane administered via the penthrox inhaler is an efficacious , safe , and rapidly acting analgesic .", "nct@ ." ]
to evaluate the short-term efficacy and safety of methoxyflurane for the treatment of acute pain in patients presenting to an emergency department ( ed ) with minor trauma . stop ! was a randomised , double-blind , multicentre , placebo-controlled study conducted at six sites in the uk . a total of @ patients , @ of whom were adolescent patients ( age @-@ years ) , were randomised @:@ to receive either methoxyflurane via a penthrox inhaler or placebo . the primary end point of the study was the change in pain intensity as measured using the visual analogue scale ( vas ) from baseline to @ , @ , @ and @ min after the start of study drug inhalation . patients were supplied with one inhaler containing @ ml methoxyflurane or @ ml placebo after enrolment and initial assessments . age group ( adolescent/adult ) and baseline vas score were controlled for in the statistical analyses . a total of @ patients received methoxyflurane , and @ patients received placebo . demographic and baseline characteristics were comparable between the groups . methoxyflurane reduced pain severity significantly more than placebo ( p < @ ) at all time points tested , with the greatest estimated treatment effect of -@ mm ( adjusted change from baseline ) seen at @ min after the start of treatment . methoxyflurane was well tolerated , with the majority of adverse reactions being mild , transient and in line with anticipated pharmacological action . the results of this study suggest that methoxyflurane administered via the penthrox inhaler is an efficacious , safe , and rapidly acting analgesic . nct@ .
24,743,584
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "research has shown that paranoia may directly build on negative ideas about the self .", "feeling inferior can lead to ideas of vulnerability .", "the clinical prediction is that decreasing negative self cognitions will reduce paranoia .", "thirty patients with persistent persecutory delusions were randomised to receive brief cbt in addition to standard care or to standard care ( isrctn@ ) .", "the six session intervention was designed to decrease negative , and increase positive , self cognitions .", "assessments at baseline , @ weeks ( posttreatment ) and @ weeks were carried out by a rater blind to allocation .", "the primary outcomes were posttreatment scores for negative self beliefs and paranoia .", "secondary outcomes were psychological well-being , positive beliefs about the self , persecutory delusions , social comparison , self-esteem , anxiety , and depression .", "trial recruitment and retention were feasible and the intervention highly acceptable to the patients .", "all patients provided follow-up data .", "posttreatment there was a small reduction in negative self beliefs ( cohen 's d = @ ) and a moderate reduction in paranoia ( d = @ ) , but these were not statistically significant .", "there were statistically significant improvements in psychological well-being ( d = @ ) , positive beliefs about the self ( d = @ ) , negative social comparison ( d = @ ) , self-esteem ( d = @ ) , and depression ( d = @ ) .", "no improvements were maintained .", "no adverse events were associated with the intervention .", "the intervention produced short-term gains consistent with the prediction that improving cognitions about the self will reduce persecutory delusions .", "the improvement in psychological well-being is important in its own right .", "we recommend that the different elements of the intervention are tested separately and that the treatment is lengthened ." ]
research has shown that paranoia may directly build on negative ideas about the self . feeling inferior can lead to ideas of vulnerability . the clinical prediction is that decreasing negative self cognitions will reduce paranoia . thirty patients with persistent persecutory delusions were randomised to receive brief cbt in addition to standard care or to standard care ( isrctn@ ) . the six session intervention was designed to decrease negative , and increase positive , self cognitions . assessments at baseline , @ weeks ( posttreatment ) and @ weeks were carried out by a rater blind to allocation . the primary outcomes were posttreatment scores for negative self beliefs and paranoia . secondary outcomes were psychological well-being , positive beliefs about the self , persecutory delusions , social comparison , self-esteem , anxiety , and depression . trial recruitment and retention were feasible and the intervention highly acceptable to the patients . all patients provided follow-up data . posttreatment there was a small reduction in negative self beliefs ( cohen 's d = @ ) and a moderate reduction in paranoia ( d = @ ) , but these were not statistically significant . there were statistically significant improvements in psychological well-being ( d = @ ) , positive beliefs about the self ( d = @ ) , negative social comparison ( d = @ ) , self-esteem ( d = @ ) , and depression ( d = @ ) . no improvements were maintained . no adverse events were associated with the intervention . the intervention produced short-term gains consistent with the prediction that improving cognitions about the self will reduce persecutory delusions . the improvement in psychological well-being is important in its own right . we recommend that the different elements of the intervention are tested separately and that the treatment is lengthened .
25,468,186
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "tissue oxygenation is a strong predictor of surgical site infection .", "improving tissue oxygenation should thus reduce wound infection risk .", "supplemental inspired oxygen can improve tissue oxygenation , but whether it reduces infection risk remains controversial .", "low-dose dexamethasone is often given to reduce the risk of postoperative nausea and vomiting , but steroid-induced immunosuppression can increase infection risk .", "we therefore tested the hypotheses that supplemental perioperative oxygen reduces infection risk and that dexamethasone increases it .", "using a factorial design , patients having colorectal resections expected to last @ h were randomly assigned to @ % ( n = @ ) or @ % ( n = @ ) inspired oxygen during and for @ h after surgery , and to @ mg intraoperative dexamethasone ( n = @ ) or placebo ( n = @ ) .", "physicians blinded to group assignments evaluated wounds postoperatively , using us centers for disease control criteria .", "subject and surgical characteristics were similar among study groups .", "surgical site infection incidence was similar among groups : @ % oxygen @ % , @ % oxygen @ % ( p = @ ) ; dexamethasone @ % , placebo @ % , ( p = @ ) .", "supplemental oxygen did not reduce surgical site infection risk .", "the preponderance of clinical evidence suggests that administration of @ % supplemental inspired oxygen does not reduce infection risk .", "we did not observe an increased risk of surgical site infection with the use of a single low dose of dexamethasone , indicating that it can be used for nausea and vomiting prophylaxis without promoting wound infections .", "clinicaltrials.gov number : nct@ ." ]
tissue oxygenation is a strong predictor of surgical site infection . improving tissue oxygenation should thus reduce wound infection risk . supplemental inspired oxygen can improve tissue oxygenation , but whether it reduces infection risk remains controversial . low-dose dexamethasone is often given to reduce the risk of postoperative nausea and vomiting , but steroid-induced immunosuppression can increase infection risk . we therefore tested the hypotheses that supplemental perioperative oxygen reduces infection risk and that dexamethasone increases it . using a factorial design , patients having colorectal resections expected to last @ h were randomly assigned to @ % ( n = @ ) or @ % ( n = @ ) inspired oxygen during and for @ h after surgery , and to @ mg intraoperative dexamethasone ( n = @ ) or placebo ( n = @ ) . physicians blinded to group assignments evaluated wounds postoperatively , using us centers for disease control criteria . subject and surgical characteristics were similar among study groups . surgical site infection incidence was similar among groups : @ % oxygen @ % , @ % oxygen @ % ( p = @ ) ; dexamethasone @ % , placebo @ % , ( p = @ ) . supplemental oxygen did not reduce surgical site infection risk . the preponderance of clinical evidence suggests that administration of @ % supplemental inspired oxygen does not reduce infection risk . we did not observe an increased risk of surgical site infection with the use of a single low dose of dexamethasone , indicating that it can be used for nausea and vomiting prophylaxis without promoting wound infections . clinicaltrials.gov number : nct@ .
25,900,659
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "mental practice using motor imagery of limb movement may facilitate motor recovery in persons who have experienced cerebrovascular accident ( cva ) .", "however , the lack of a feedback mechanism that can monitor the quality of the motor imagery affects patients ' engagement and motivation to participate in the mental practice training program .", "this study investigates the effect of novel real-time motor imagery-associated cortical activity feedback on motor imagery-based mental practice training .", "ten healthy volunteers were randomly assigned into intervention and control groups .", "both groups participated in a five-visit motor imagery-based mental practice training program managed over a period of two months .", "the intervention group received mental practice training with real-time feedback of movement-associated cortical activity-beta band ( @-@ hz ) event-related desynchronization ( erd ) in electroencephalography ( eeg ) , using a novel custom-made brain-computer interface ( bci ) system .", "the control group received the mental practice training program without eeg cortical feedback .", "motor excitability was assessed by measuring the frequency power magnitude of the eeg rhythmic activity associated with physical execution of wrist extension before and after the motor imagery-based mental practice training .", "the eeg frequency power magnitude associated with the physical execution of wrist extension was significantly lower ( i.e. more desynchronized ) after the mental practice training in the intervention group that received real-time cortical feedback ( p < @ ) , whereas no significant difference in eeg frequency power magnitude associated with the physical execution of wrist extension was observed before and after mental practice training in the control group who did not receive feedback .", "the mental practice training program with motor imagery-associated cortical feedback facilitated motor excitability during the production of voluntary motor control .", "motor imagery-based mental practice training with movement-associated cortical activity feedback may provide an effective strategy to facilitate motor recovery in brain injury patients , particularly during the early rehabilitation stage when full participation in physical and occupational therapy programs may not be possible due to excessive motor weakness ." ]
mental practice using motor imagery of limb movement may facilitate motor recovery in persons who have experienced cerebrovascular accident ( cva ) . however , the lack of a feedback mechanism that can monitor the quality of the motor imagery affects patients ' engagement and motivation to participate in the mental practice training program . this study investigates the effect of novel real-time motor imagery-associated cortical activity feedback on motor imagery-based mental practice training . ten healthy volunteers were randomly assigned into intervention and control groups . both groups participated in a five-visit motor imagery-based mental practice training program managed over a period of two months . the intervention group received mental practice training with real-time feedback of movement-associated cortical activity-beta band ( @-@ hz ) event-related desynchronization ( erd ) in electroencephalography ( eeg ) , using a novel custom-made brain-computer interface ( bci ) system . the control group received the mental practice training program without eeg cortical feedback . motor excitability was assessed by measuring the frequency power magnitude of the eeg rhythmic activity associated with physical execution of wrist extension before and after the motor imagery-based mental practice training . the eeg frequency power magnitude associated with the physical execution of wrist extension was significantly lower ( i.e. more desynchronized ) after the mental practice training in the intervention group that received real-time cortical feedback ( p < @ ) , whereas no significant difference in eeg frequency power magnitude associated with the physical execution of wrist extension was observed before and after mental practice training in the control group who did not receive feedback . the mental practice training program with motor imagery-associated cortical feedback facilitated motor excitability during the production of voluntary motor control . motor imagery-based mental practice training with movement-associated cortical activity feedback may provide an effective strategy to facilitate motor recovery in brain injury patients , particularly during the early rehabilitation stage when full participation in physical and occupational therapy programs may not be possible due to excessive motor weakness .
24,401,829
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death .", "this double-blind randomized trial was conducted at five tertiary-level hospitals in the united states and vietnam .", "one hundred fifty-three women with an intrauterine fetal death at @-@ weeks of pregnancy received either @ mcg buccal misoprostol or @ mcg buccal misoprostol every @ h for a maximum of @ doses .", "the main outcome measure was the fetal-placental delivery rate within @ hours of prostaglandin commencement without any additional intervention .", "most of the women ( @/@ ) were recruited at the study site in vietnam .", "expulsion of both fetus and placenta within @ hours of prostaglandin commencement without any additional interventions occurred in @ % ( @/@ ) of women receiving misoprostol @ mcg and @ % ( @/@ ) of women receiving misoprostol @ mcg .", "the @ mcg dose was significantly more effective than the @ mcg dose at expelling the fetus and placenta within @ h -lsb- rr @ ( @ % ci : @-@ @ ; p = @ ) -rsb- .", "the mean time to expulsion was significantly shorter using the @ mcg dose ( @ h ) than the @ mcg dose ( @ h ) ( p = @ ) .", "most women in both groups found the procedure satisfactory or very satisfactory ( @ mcg : @ % ( @/@ ) ; @ mcg : @ % ( @/@ ) -lsb- rr @ ( @ % ci : @-@ @ ) -rsb- .", "buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise .", "a @ mcg dose is significantly more effective than @ mcg for evacuating the uterus within @h .", "the treatment is highly acceptable to women .", "administration of @ mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at @-@ weeks that can be feasibly implemented in a wide variety of settings ." ]
to assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death . this double-blind randomized trial was conducted at five tertiary-level hospitals in the united states and vietnam . one hundred fifty-three women with an intrauterine fetal death at @-@ weeks of pregnancy received either @ mcg buccal misoprostol or @ mcg buccal misoprostol every @ h for a maximum of @ doses . the main outcome measure was the fetal-placental delivery rate within @ hours of prostaglandin commencement without any additional intervention . most of the women ( @/@ ) were recruited at the study site in vietnam . expulsion of both fetus and placenta within @ hours of prostaglandin commencement without any additional interventions occurred in @ % ( @/@ ) of women receiving misoprostol @ mcg and @ % ( @/@ ) of women receiving misoprostol @ mcg . the @ mcg dose was significantly more effective than the @ mcg dose at expelling the fetus and placenta within @ h -lsb- rr @ ( @ % ci : @-@ @ ; p = @ ) -rsb- . the mean time to expulsion was significantly shorter using the @ mcg dose ( @ h ) than the @ mcg dose ( @ h ) ( p = @ ) . most women in both groups found the procedure satisfactory or very satisfactory ( @ mcg : @ % ( @/@ ) ; @ mcg : @ % ( @/@ ) -lsb- rr @ ( @ % ci : @-@ @ ) -rsb- . buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise . a @ mcg dose is significantly more effective than @ mcg for evacuating the uterus within @h . the treatment is highly acceptable to women . administration of @ mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at @-@ weeks that can be feasibly implemented in a wide variety of settings .
24,405,797
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]