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"millions of children worldwide suffer from posttraumatic stress disorder ( ptsd ) symptoms and other mental health problems due to repeated exposure to war or organized violence .",
"forms of cognitive-behavioral therapy ( cbt ) are the most commonly used treatment for ptsd and appear to be effective for children as well , but little is known about the mechanisms of change through which they achieve their effectiveness .",
"here we present the study protocol of a randomized controlled trial ( rct ) studying the effectiveness and mechanisms of change of narrative exposure therapy ( net ) , a cbt-based , manualized , short-term intervention for ptsd symptoms resulting from repeated traumatization , in immigrant children traumatized by war .",
"we are conducting a multicentre , pragmatic rct in a usual care setting .",
"up to @ @-@-year-old immigrant children who have experienced war and suffer from ptsd symptoms will be randomized into intervention ( net ) and control ( treatment as usual , tau ) groups of equal sizes .",
"the effectiveness of net treatment will be compared to both a waiting list and the parallel tau positive control group , on the primary outcomes of ptsd and depressive symptoms , psychological distress , resilience , and level of cognitive performance .",
"the effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness .",
"the possible moderating effects of peritraumatic dissociation , level of cognitive performance , and gender on treatment effectiveness will also be considered .",
"we hypothesize that net will be more effective than a waitlist condition or tau in reducing ptsd and other symptoms and improving resilience , and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions .",
"the results of this trial will provide evidence for the effectiveness of net in treating trauma-related symptoms in immigrant children affected by war .",
"the trial will also generate insights into the complex relationships between ptsd , memory functions , posttraumatic cognitions and cognitive performance in children , and help guide the future development and implementation of therapeutic interventions for ptsd in children .",
"clinicaltrials.gov nct@ .",
"registered @ april @ ."
] | millions of children worldwide suffer from posttraumatic stress disorder ( ptsd ) symptoms and other mental health problems due to repeated exposure to war or organized violence . forms of cognitive-behavioral therapy ( cbt ) are the most commonly used treatment for ptsd and appear to be effective for children as well , but little is known about the mechanisms of change through which they achieve their effectiveness . here we present the study protocol of a randomized controlled trial ( rct ) studying the effectiveness and mechanisms of change of narrative exposure therapy ( net ) , a cbt-based , manualized , short-term intervention for ptsd symptoms resulting from repeated traumatization , in immigrant children traumatized by war . we are conducting a multicentre , pragmatic rct in a usual care setting . up to @ @-@-year-old immigrant children who have experienced war and suffer from ptsd symptoms will be randomized into intervention ( net ) and control ( treatment as usual , tau ) groups of equal sizes . the effectiveness of net treatment will be compared to both a waiting list and the parallel tau positive control group , on the primary outcomes of ptsd and depressive symptoms , psychological distress , resilience , and level of cognitive performance . the effects of the intervention on traumatic memories and posttraumatic cognitions will be studied as potential mechanisms of change mediating overall treatment effectiveness . the possible moderating effects of peritraumatic dissociation , level of cognitive performance , and gender on treatment effectiveness will also be considered . we hypothesize that net will be more effective than a waitlist condition or tau in reducing ptsd and other symptoms and improving resilience , and that these effects will be mediated by changes in traumatic memories and posttraumatic cognitions . the results of this trial will provide evidence for the effectiveness of net in treating trauma-related symptoms in immigrant children affected by war . the trial will also generate insights into the complex relationships between ptsd , memory functions , posttraumatic cognitions and cognitive performance in children , and help guide the future development and implementation of therapeutic interventions for ptsd in children . clinicaltrials.gov nct@ . registered @ april @ . | 26,081,580 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND",
"BACKGROUND"
] |
[
"docosahexaenoic acid ( dha ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases .",
"we recently assessed efficacy of high-dose dha supplementation to slow vision loss in patients with x-linked retinitis pigmentosa ( xlrp ) in a randomized clinical trial .",
"because dha is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress .",
"biosafety was monitored during the @-year trial to determine whether dha supplementation was associated with identifiable risks .",
"males ( n = @ ; @-@ years ) meeting entry criteria were enrolled .",
"the modified intent-to-treat cohort ( dha = @ ; placebo = @ ) adhered to the protocol @ year .",
"participants were randomized to an oral dose of @ mg/kg/d dha or placebo plus a daily multivitamin .",
"comprehensive metabolic analyses were assessed for group differences .",
"treatment-emergent adverse events including blood chemistry metabolites were recorded .",
"by year @ , supplementation elevated plasma and red blood cell-dha @ - and @-fold , respectively , compared with the placebo group ( p < @ ) .",
"over the trial duration , no significant differences between dha and placebo groups were found for vitamin a , vitamin e , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized ldl levels ( all p > @ ) .",
"adverse events were transient and not considered severe ( e.g. , gastrointestinal -lsb- gi -rsb- irritability , blood chemistry alterations ) .",
"one participant was unable to tolerate persistent gi discomfort .",
"long-term , high-dose dha supplementation to patients with xlrp was associated with limited safety risks in this @-year trial .",
"nevertheless , gi symptoms should be monitored in all patients taking high dose dha especially those with personal or family history of gi disturbances .",
"( clinicaltrials.gov number , nct@ . )"
] | docosahexaenoic acid ( dha ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases . we recently assessed efficacy of high-dose dha supplementation to slow vision loss in patients with x-linked retinitis pigmentosa ( xlrp ) in a randomized clinical trial . because dha is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress . biosafety was monitored during the @-year trial to determine whether dha supplementation was associated with identifiable risks . males ( n = @ ; @-@ years ) meeting entry criteria were enrolled . the modified intent-to-treat cohort ( dha = @ ; placebo = @ ) adhered to the protocol @ year . participants were randomized to an oral dose of @ mg/kg/d dha or placebo plus a daily multivitamin . comprehensive metabolic analyses were assessed for group differences . treatment-emergent adverse events including blood chemistry metabolites were recorded . by year @ , supplementation elevated plasma and red blood cell-dha @ - and @-fold , respectively , compared with the placebo group ( p < @ ) . over the trial duration , no significant differences between dha and placebo groups were found for vitamin a , vitamin e , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized ldl levels ( all p > @ ) . adverse events were transient and not considered severe ( e.g. , gastrointestinal -lsb- gi -rsb- irritability , blood chemistry alterations ) . one participant was unable to tolerate persistent gi discomfort . long-term , high-dose dha supplementation to patients with xlrp was associated with limited safety risks in this @-year trial . nevertheless , gi symptoms should be monitored in all patients taking high dose dha especially those with personal or family history of gi disturbances . ( clinicaltrials.gov number , nct@ . ) | 25,015,354 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"a lack of physical activity and overconsumption of energy dense food is associated with overweight and obesity .",
"the neighbourhood environment may stimulate or hinder the development and/or maintenance of a healthy lifestyle .",
"to improve research on the obesogenicity of neighbourhood environments , reliable , valid and convenient assessment methods of potential obesogenic characteristics of neighbourhood environments are needed .",
"this study examines the reliability and validity of the spotlight-virtual audit tool ( s-vat ) , which uses remote sensing techniques ( street view feature in google earth ) for desk-based assessment of environmental obesogenicity .",
"a total of @ street segments in four dutch urban neighbourhoods - heterogeneous in socio-economic status and residential density - were assessed using the s-vat .",
"environmental characteristics were categorised as walking related items , cycling related items , public transport , aesthetics , land use-mix , grocery stores , food outlets and physical activity facilities .",
"to assess concordance of inter - and intra-observer reliability of the street view feature in google earth , and validity scores with real life audits , percentage agreement and cohen 's kappa ( k ) were calculated .",
"intra-observer reliability was high and ranged from @ % agreement ( k = @ ) to @ % agreement ( k = @ ) with an overall agreement of @ % ( k = @ ) .",
"inter-observer reliability results ranged from substantial agreement @ % ( k = @ ) to high agreement , @ % ( k = @ ) , with an overall agreement of @ % ( k = @ ) .",
"criterion validity was substantial to high for most of the categories ranging from @ % agreement ( k = @ ) to @ % agreement ( k = @ ) with an overall score of @ % agreement ( k = @ ) .",
"these study results suggest that the s-vat is a highly reliable and valid remote sensing tool to assess potential obesogenic environmental characteristics ."
] | a lack of physical activity and overconsumption of energy dense food is associated with overweight and obesity . the neighbourhood environment may stimulate or hinder the development and/or maintenance of a healthy lifestyle . to improve research on the obesogenicity of neighbourhood environments , reliable , valid and convenient assessment methods of potential obesogenic characteristics of neighbourhood environments are needed . this study examines the reliability and validity of the spotlight-virtual audit tool ( s-vat ) , which uses remote sensing techniques ( street view feature in google earth ) for desk-based assessment of environmental obesogenicity . a total of @ street segments in four dutch urban neighbourhoods - heterogeneous in socio-economic status and residential density - were assessed using the s-vat . environmental characteristics were categorised as walking related items , cycling related items , public transport , aesthetics , land use-mix , grocery stores , food outlets and physical activity facilities . to assess concordance of inter - and intra-observer reliability of the street view feature in google earth , and validity scores with real life audits , percentage agreement and cohen 's kappa ( k ) were calculated . intra-observer reliability was high and ranged from @ % agreement ( k = @ ) to @ % agreement ( k = @ ) with an overall agreement of @ % ( k = @ ) . inter-observer reliability results ranged from substantial agreement @ % ( k = @ ) to high agreement , @ % ( k = @ ) , with an overall agreement of @ % ( k = @ ) . criterion validity was substantial to high for most of the categories ranging from @ % agreement ( k = @ ) to @ % agreement ( k = @ ) with an overall score of @ % agreement ( k = @ ) . these study results suggest that the s-vat is a highly reliable and valid remote sensing tool to assess potential obesogenic environmental characteristics . | 25,515,179 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to describe the prognostic value of three novel biomarkers for acute adverse kidney events compared with routine biological markers .",
"we used high-end ms to quantify biomarkers predictive of acute kidney injury ( aki ) and major adverse kidney events ( make ) in @ adult patients after open heart surgery ( n = @ ) .",
"early postoperatively measured lg@ ( a c-terminal fragment of perlecan ) , ltbp@ ( latent transforming growth factor binding protein-@ ) , cathepsin l as well as two other renal biomarkers ( ngal , cystatin c ) had greater predictive value for aki ( n = @ ) and make ( n = @ ) compared with creatinine , urea and urine output .",
"lg@ , ltbp@ and cathepsin l deserve further exploration as biomarkers for the early identification of patients at risk of make ."
] | to describe the prognostic value of three novel biomarkers for acute adverse kidney events compared with routine biological markers . we used high-end ms to quantify biomarkers predictive of acute kidney injury ( aki ) and major adverse kidney events ( make ) in @ adult patients after open heart surgery ( n = @ ) . early postoperatively measured lg@ ( a c-terminal fragment of perlecan ) , ltbp@ ( latent transforming growth factor binding protein-@ ) , cathepsin l as well as two other renal biomarkers ( ngal , cystatin c ) had greater predictive value for aki ( n = @ ) and make ( n = @ ) compared with creatinine , urea and urine output . lg@ , ltbp@ and cathepsin l deserve further exploration as biomarkers for the early identification of patients at risk of make . | 25,525,981 | [
"OBJECTIVE",
"METHODS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to investigate the effects of exercise preconditioning on oxidative injury in the intestinal tissue of rats .",
"sixty male wistar rats were randomly divided into six groups as sham ( n = @ ) , ischemia-reperfusion ( n = @ ) , exercise ( n = @ ) , exercise plus ischemia-reperfusion ( n = @ ) , ischemic preconditioning ( n = @ ) , and ischemic preconditioning plus ischemia-reperfusion groups ( n = @ ) .",
"tissue levels of malondialdehyde and activities of myeloperoxidase and superoxide dismutase , and serum levels of tumor necrosis factor-alpha and interleukin-@ were measured .",
"intestinal tissue histopathology was also evaluated by light microscopy .",
"tumor necrosis factor-alpha concentrations significantly decreased in the exercise group compared to the sham group ( p < @ ) .",
"myeloperoxidase activity significantly increased and superoxide dismutase activity significantly decreased in ischemia-reperfusion group compared to the sham group ( p < @ ) .",
"superoxide dismutase activity in the ischemic preconditioning and ischemic preconditioning plus ischemia-reperfusion groups were significantly higher compared to the ischemia-reperfusion and exercise groups ( p < @ ) .",
"histopathologically , intestinal injury significantly attenuated in the exercise plus ischemia-reperfusion group compared to the ischemia-reperfusion group .",
"the results of the present study indicate that exercise training seems to have a protective role against intestinal ischemia-reperfusion injury ( tab .",
"@ , fig. @ , ref .",
"@ ) ."
] | to investigate the effects of exercise preconditioning on oxidative injury in the intestinal tissue of rats . sixty male wistar rats were randomly divided into six groups as sham ( n = @ ) , ischemia-reperfusion ( n = @ ) , exercise ( n = @ ) , exercise plus ischemia-reperfusion ( n = @ ) , ischemic preconditioning ( n = @ ) , and ischemic preconditioning plus ischemia-reperfusion groups ( n = @ ) . tissue levels of malondialdehyde and activities of myeloperoxidase and superoxide dismutase , and serum levels of tumor necrosis factor-alpha and interleukin-@ were measured . intestinal tissue histopathology was also evaluated by light microscopy . tumor necrosis factor-alpha concentrations significantly decreased in the exercise group compared to the sham group ( p < @ ) . myeloperoxidase activity significantly increased and superoxide dismutase activity significantly decreased in ischemia-reperfusion group compared to the sham group ( p < @ ) . superoxide dismutase activity in the ischemic preconditioning and ischemic preconditioning plus ischemia-reperfusion groups were significantly higher compared to the ischemia-reperfusion and exercise groups ( p < @ ) . histopathologically , intestinal injury significantly attenuated in the exercise plus ischemia-reperfusion group compared to the ischemia-reperfusion group . the results of the present study indicate that exercise training seems to have a protective role against intestinal ischemia-reperfusion injury ( tab . @ , fig. @ , ref . @ ) . | 25,077,364 | [
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to observe the sedative and analgesic effects of dexmedetomidine ( dex ) and its influence on respiration and blood pressure , evaluate electrophysiological monitoring and explore the optimal dose of dex for brain nuclei lesion in parkinson 's disease ( pd ) patients .",
"approved by hospital ethics committee , @ pd patients undergoing brain nuclei lesion ablation were randomly allocated into @ groups ( n = @ each ) .",
"no sedative anesthetic was used in group a ; in group b , dex @ g/kg intravenously for initial bolus ( duration @ min ) and then @ gkg ( -@ ) h ( -@ ) continuous infusion ; in group c , dex @ g/kg intravenously ( duration @ min ) for initial load and then @ gkg ( -@ ) h ( -@ ) continuous infusion .",
"the parameters of mean arterial pressure ( map ) , heart rate ( hr ) , pressure of end-tidal carbon dioxide ( p etco@ ) , respiratory rate , blood oxygen saturation ( spo@ ) , observer 's assessment of alertness/sedation ( oaa/s ) and verbal rating score ( vrs ) were recorded at @ min ( baseline ) , @ min ( t@ ) , @ min ( t@ ) , @ min ( t@ ) , @ min ( t@ ) , @ min ( t@ ) and @ min ( t@ ) after the dosing of dex .",
"hr and respiratory rate decreased in groups b and c compared with baseline .",
"in group c , p etco@ was much higher , compared with baseline ( p < @ ) .",
"blood pressures of three groups were well-controlled .",
"the incidence of pain ( vrs @ ) in group a was significantly higher than those of groups b and c ( p < @ ) .",
"and the incidence of sedation ( oaa/s > @ ) in group c was much higher than those of groups a and b.",
"the electrophysiological signal of two patients in group c was severely affected .",
"at an initial intravenous dose of dex @ g/kg and a maintenance dose of @ g kg ( -@ ) h ( -@ ) , electrophysiological monitoring for surgery is not affected in pd patients undergoing brain nuclei lesion ablation .",
"with a minimal interference of breath , dex has not only well-controlled effects on sedation , analgesia and blood pressure , but also makes patients comfortable ."
] | to observe the sedative and analgesic effects of dexmedetomidine ( dex ) and its influence on respiration and blood pressure , evaluate electrophysiological monitoring and explore the optimal dose of dex for brain nuclei lesion in parkinson 's disease ( pd ) patients . approved by hospital ethics committee , @ pd patients undergoing brain nuclei lesion ablation were randomly allocated into @ groups ( n = @ each ) . no sedative anesthetic was used in group a ; in group b , dex @ g/kg intravenously for initial bolus ( duration @ min ) and then @ gkg ( -@ ) h ( -@ ) continuous infusion ; in group c , dex @ g/kg intravenously ( duration @ min ) for initial load and then @ gkg ( -@ ) h ( -@ ) continuous infusion . the parameters of mean arterial pressure ( map ) , heart rate ( hr ) , pressure of end-tidal carbon dioxide ( p etco@ ) , respiratory rate , blood oxygen saturation ( spo@ ) , observer 's assessment of alertness/sedation ( oaa/s ) and verbal rating score ( vrs ) were recorded at @ min ( baseline ) , @ min ( t@ ) , @ min ( t@ ) , @ min ( t@ ) , @ min ( t@ ) , @ min ( t@ ) and @ min ( t@ ) after the dosing of dex . hr and respiratory rate decreased in groups b and c compared with baseline . in group c , p etco@ was much higher , compared with baseline ( p < @ ) . blood pressures of three groups were well-controlled . the incidence of pain ( vrs @ ) in group a was significantly higher than those of groups b and c ( p < @ ) . and the incidence of sedation ( oaa/s > @ ) in group c was much higher than those of groups a and b. the electrophysiological signal of two patients in group c was severely affected . at an initial intravenous dose of dex @ g/kg and a maintenance dose of @ g kg ( -@ ) h ( -@ ) , electrophysiological monitoring for surgery is not affected in pd patients undergoing brain nuclei lesion ablation . with a minimal interference of breath , dex has not only well-controlled effects on sedation , analgesia and blood pressure , but also makes patients comfortable . | 24,360,050 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to characterize subgroups of subjects with schizophrenia from the ziprasidone observational study of cardiac outcomes ( zodiac ) trial who either completed or attempted suicide and those who did not .",
"the zodiac , conducted between february @ and march @ , was an open-label , randomized , large simple trial of patients with schizophrenia ( n = @,@ ) followed up for @ year by unblinded investigators providing usual care in @ countries ; the primary outcome measure was nonsuicide mortality .",
"every report on a completed or attempted suicide was independently adjudicated using a predefined algorithm .",
"primary analysis for the current report examined the association between completed or attempted suicides and the baseline variables using descriptive statistics and multivariate logistic regression models .",
"usage of `` hard '' or `` soft '' methods for attempted or completed suicide and distribution of suicide-related events by geographical region were also summarized .",
"overall incidences of subjects who either completed ( @/@ ,@ ) or attempted ( @/@ ,@ ) suicide were low , as were rates per person-time on assigned treatment analysis ( @ for completed and @ for attempted suicides per @ person-years of exposure ) .",
"the highest suicide-related mortality was seen among subjects recently diagnosed with schizophrenia .",
"among all potential baseline risk factors for completed suicide examined , the variables most associated with completed suicide were history of suicide attempts ( or = @ ; @ % ci , @-@ @ ) and usage of antidepressant medication ( or = @ ; @ % ci , @-@ @ ) .",
"history of > @ hospitalizations in the past ( or = @ ; @ % ci , @-@ @ ) and history of suicide attempts ( or = @ ; @ % ci , @-@ @ ) were the variables most associated with attempted suicide among potential baseline risk factors for suicide attempts .",
"our results , obtained in a large prospective randomized study , confirm current clinical understanding regarding completed or attempted suicide in schizophrenia and the associated risk factors .",
"clinicaltrials.gov identifier : nct@ ."
] | to characterize subgroups of subjects with schizophrenia from the ziprasidone observational study of cardiac outcomes ( zodiac ) trial who either completed or attempted suicide and those who did not . the zodiac , conducted between february @ and march @ , was an open-label , randomized , large simple trial of patients with schizophrenia ( n = @,@ ) followed up for @ year by unblinded investigators providing usual care in @ countries ; the primary outcome measure was nonsuicide mortality . every report on a completed or attempted suicide was independently adjudicated using a predefined algorithm . primary analysis for the current report examined the association between completed or attempted suicides and the baseline variables using descriptive statistics and multivariate logistic regression models . usage of `` hard '' or `` soft '' methods for attempted or completed suicide and distribution of suicide-related events by geographical region were also summarized . overall incidences of subjects who either completed ( @/@ ,@ ) or attempted ( @/@ ,@ ) suicide were low , as were rates per person-time on assigned treatment analysis ( @ for completed and @ for attempted suicides per @ person-years of exposure ) . the highest suicide-related mortality was seen among subjects recently diagnosed with schizophrenia . among all potential baseline risk factors for completed suicide examined , the variables most associated with completed suicide were history of suicide attempts ( or = @ ; @ % ci , @-@ @ ) and usage of antidepressant medication ( or = @ ; @ % ci , @-@ @ ) . history of > @ hospitalizations in the past ( or = @ ; @ % ci , @-@ @ ) and history of suicide attempts ( or = @ ; @ % ci , @-@ @ ) were the variables most associated with attempted suicide among potential baseline risk factors for suicide attempts . our results , obtained in a large prospective randomized study , confirm current clinical understanding regarding completed or attempted suicide in schizophrenia and the associated risk factors . clinicaltrials.gov identifier : nct@ . | 24,717,389 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"to evaluate the efficacy of a short-term intravenous infusion of levosimendan in patients with heart failure due to acute myocardial infarction ( ami ) .",
"this was a randomized , single-center , single-blind study that included @ patients .",
"patients were randomly divided into @ groups : @ received levosimendan ( n = @ ) and the other received placebo ( n = @ ) .",
"the study included multiple primary end points ( death , myocardial ischemia or worsening heart at the @ month follow-up ) and used a composite outcome .",
"the primary end point rate in the levosimendan group was lower than that in placebo group ( @ vs. @ % , hr @ , @ % ci @-@ @ , p = @ ) .",
"moreover , the mortality rate at @ months was similar between the @ groups ( @ vs. @ % , hr @ , @ % ci @-@ @ , p = @ ) .",
"there was a higher incidence of myocardial ischemia in the levosimendan group at @ days than in the placebo group ( @ vs. @ % , hr @ , p = @ ) , but between @ and @ days , it was significantly lower in the levosimendan group than in the placebo group ( @ vs. @ % , hr @ , p = @ ) .",
"short-term intravenous infusion of levosimendan appears to be more effective than placebo for treating patients with heart failure complicated by ami ."
] | to evaluate the efficacy of a short-term intravenous infusion of levosimendan in patients with heart failure due to acute myocardial infarction ( ami ) . this was a randomized , single-center , single-blind study that included @ patients . patients were randomly divided into @ groups : @ received levosimendan ( n = @ ) and the other received placebo ( n = @ ) . the study included multiple primary end points ( death , myocardial ischemia or worsening heart at the @ month follow-up ) and used a composite outcome . the primary end point rate in the levosimendan group was lower than that in placebo group ( @ vs. @ % , hr @ , @ % ci @-@ @ , p = @ ) . moreover , the mortality rate at @ months was similar between the @ groups ( @ vs. @ % , hr @ , @ % ci @-@ @ , p = @ ) . there was a higher incidence of myocardial ischemia in the levosimendan group at @ days than in the placebo group ( @ vs. @ % , hr @ , p = @ ) , but between @ and @ days , it was significantly lower in the levosimendan group than in the placebo group ( @ vs. @ % , hr @ , p = @ ) . short-term intravenous infusion of levosimendan appears to be more effective than placebo for treating patients with heart failure complicated by ami . | 24,751,462 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to determine if supervised exercise minimises treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy ( adt ) .",
"this is the first study to date that has investigated the potential role of exercise in preventing adt toxicity rather than recovering from established toxicities .",
"sixty-three men scheduled to receive adt were randomly assigned to a @-month supervised exercise programme involving aerobic and resistance exercise sessions commenced within @ days of their first adt injection ( @ men ) or usual care ( @ men ) .",
"the primary outcome was body composition ( lean and fat mass ) .",
"other study outcomes included bone mineral density , physical function , blood biomarkers of chronic disease risk and bone turnover , general and prostate cancer-specific quality of life , fatigue and psychological distress .",
"outcomes were compared between groups using analysis of covariance adjusted for baseline values .",
"compared to usual care , a @-month exercise programme preserved appendicular lean mass ( p = @ ) and prevented gains in whole body fat mass , trunk fat mass and percentage fat with group differences of -@ kg ( p = @ ) , -@ kg ( p = @ ) and -@ % ( p < @ ) , respectively .",
"significant between-group differences were also seen favouring the exercise group for cardiovascular fitness ( peak oxygen consumption @ ml/kg/min , p = @ ) , muscular strength ( @-@ @ kg , p @ ) , lower body function ( -@ s , p < @ ) , total cholesterol : high-density lipoprotein-cholesterol ratio ( -@ , p = @ ) , sexual function ( @ , p = @ ) , fatigue ( @ , p = @ ) , psychological distress ( -@ , p = @ ) , social functioning ( @ , p = @ ) and mental health ( @-@ @ , p @ ) .",
"there were no significant group differences for any other outcomes .",
"commencing a supervised exercise programme involving aerobic and resistance exercise when initiating adt significantly reduced treatment toxicity , while improving social functioning and mental health .",
"concurrent prescription of supervised exercise when initiating adt is therefore advised to minimise morbidity associated with severe hypogonadism ."
] | to determine if supervised exercise minimises treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy ( adt ) . this is the first study to date that has investigated the potential role of exercise in preventing adt toxicity rather than recovering from established toxicities . sixty-three men scheduled to receive adt were randomly assigned to a @-month supervised exercise programme involving aerobic and resistance exercise sessions commenced within @ days of their first adt injection ( @ men ) or usual care ( @ men ) . the primary outcome was body composition ( lean and fat mass ) . other study outcomes included bone mineral density , physical function , blood biomarkers of chronic disease risk and bone turnover , general and prostate cancer-specific quality of life , fatigue and psychological distress . outcomes were compared between groups using analysis of covariance adjusted for baseline values . compared to usual care , a @-month exercise programme preserved appendicular lean mass ( p = @ ) and prevented gains in whole body fat mass , trunk fat mass and percentage fat with group differences of -@ kg ( p = @ ) , -@ kg ( p = @ ) and -@ % ( p < @ ) , respectively . significant between-group differences were also seen favouring the exercise group for cardiovascular fitness ( peak oxygen consumption @ ml/kg/min , p = @ ) , muscular strength ( @-@ @ kg , p @ ) , lower body function ( -@ s , p < @ ) , total cholesterol : high-density lipoprotein-cholesterol ratio ( -@ , p = @ ) , sexual function ( @ , p = @ ) , fatigue ( @ , p = @ ) , psychological distress ( -@ , p = @ ) , social functioning ( @ , p = @ ) and mental health ( @-@ @ , p @ ) . there were no significant group differences for any other outcomes . commencing a supervised exercise programme involving aerobic and resistance exercise when initiating adt significantly reduced treatment toxicity , while improving social functioning and mental health . concurrent prescription of supervised exercise when initiating adt is therefore advised to minimise morbidity associated with severe hypogonadism . | 24,467,669 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"endoscopic mucosal resection ( emr ) is simple and quick and has low complication rates .",
"however , the disadvantage of local recurrence or remnant rate limits the use of this technique .",
"we aimed to analyse the outcomes of conventional emr and emr with circumferential incision ( ciemr ) , a simplified modification of emr , in the endoscopic treatment of rectal carcinoid tumours .",
"a total of @ consecutive patients with rectal carcinoid tumours without regional lymph node enlargement confirmed by endoscopic ultrasonography were included in the study .",
"these patients underwent endoscopic treatment from january @ to september @ and were randomly designated into ciemr ( n = @ ) or emr group ( n = @ ) .",
"en bloc resection rate , pathological complete resection rate , procedure time , complications and follow-up outcomes were analysed .",
"the en bloc resection rate was not significantly different between the ciemr and emr groups ( @ % versus @ % , p > @ ) .",
"the pathological complete resection rate was higher in the ciemr group than in the emr group ( @ % versus @ % , p < @ ) .",
"the overall complication rate , delayed bleeding and procedure time were not significantly different between the two groups .",
"no recurrence was observed in either the emr or ciemr group .",
"ciemr optimises the procedure of emr and simplifies the technique of endoscopic submucosal dissection ; thus , it has a better histologically complete resection rate and more acceptable complication rate than emr .",
"thus , ciemr may be preferable to conventional emr for resection of rectal carcinoid tumours less than @ mm ."
] | endoscopic mucosal resection ( emr ) is simple and quick and has low complication rates . however , the disadvantage of local recurrence or remnant rate limits the use of this technique . we aimed to analyse the outcomes of conventional emr and emr with circumferential incision ( ciemr ) , a simplified modification of emr , in the endoscopic treatment of rectal carcinoid tumours . a total of @ consecutive patients with rectal carcinoid tumours without regional lymph node enlargement confirmed by endoscopic ultrasonography were included in the study . these patients underwent endoscopic treatment from january @ to september @ and were randomly designated into ciemr ( n = @ ) or emr group ( n = @ ) . en bloc resection rate , pathological complete resection rate , procedure time , complications and follow-up outcomes were analysed . the en bloc resection rate was not significantly different between the ciemr and emr groups ( @ % versus @ % , p > @ ) . the pathological complete resection rate was higher in the ciemr group than in the emr group ( @ % versus @ % , p < @ ) . the overall complication rate , delayed bleeding and procedure time were not significantly different between the two groups . no recurrence was observed in either the emr or ciemr group . ciemr optimises the procedure of emr and simplifies the technique of endoscopic submucosal dissection ; thus , it has a better histologically complete resection rate and more acceptable complication rate than emr . thus , ciemr may be preferable to conventional emr for resection of rectal carcinoid tumours less than @ mm . | 24,472,342 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"one-quarter of the world 's population will suffer from depression symptoms at some point in their lives .",
"mental health services in developed countries are overburdened .",
"therefore , cost-effective interventions that provide mental health care solutions such as web-based psychotherapy programs have been proposed .",
"the intent of the study was to identify expectations regarding web-based psychotherapy for the treatment of depression in primary care among patients and health professionals that might facilitate or hinder its effects .",
"the expectations of untreated patients and health professionals were examined by means of interviews and focus groups .",
"there were @ participants ( @ patients with mild and moderate levels of depression , @ primary care physicians , and @ managers ; @ of them for interviews and @ for groups ) .",
"a thematic content analysis from the grounded theory for interviews , and an analysis of the discursive positions of participants based on the sociological model for groups were performed .",
"interpretations were achieved by agreement between three independent analysts .",
"all participants showed a good general acceptance of web-based psychotherapy , appreciating possible advantages and improvements .",
"patients , physicians , and managers shared the same conceptualization of their expectations , although highlighting different aspects .",
"patients focused on the need for individualized and personalized interaction , while professionals highlighted the need for the standardization of the program .",
"physicians were concerned with extra workload , while managers were worried about optimizing cost-effectiveness .",
"expectations of the different participants can conflict with each other .",
"finding a balanced position among them is needed if we are to harmoniously implement effective web-based interventions for depression in routine clinical practice ."
] | one-quarter of the world 's population will suffer from depression symptoms at some point in their lives . mental health services in developed countries are overburdened . therefore , cost-effective interventions that provide mental health care solutions such as web-based psychotherapy programs have been proposed . the intent of the study was to identify expectations regarding web-based psychotherapy for the treatment of depression in primary care among patients and health professionals that might facilitate or hinder its effects . the expectations of untreated patients and health professionals were examined by means of interviews and focus groups . there were @ participants ( @ patients with mild and moderate levels of depression , @ primary care physicians , and @ managers ; @ of them for interviews and @ for groups ) . a thematic content analysis from the grounded theory for interviews , and an analysis of the discursive positions of participants based on the sociological model for groups were performed . interpretations were achieved by agreement between three independent analysts . all participants showed a good general acceptance of web-based psychotherapy , appreciating possible advantages and improvements . patients , physicians , and managers shared the same conceptualization of their expectations , although highlighting different aspects . patients focused on the need for individualized and personalized interaction , while professionals highlighted the need for the standardization of the program . physicians were concerned with extra workload , while managers were worried about optimizing cost-effectiveness . expectations of the different participants can conflict with each other . finding a balanced position among them is needed if we are to harmoniously implement effective web-based interventions for depression in routine clinical practice . | 25,757,358 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"eortc trial @ examined the addition of preoperative or postoperative chemotherapy to preoperative radiotherapy in patients with rectal cancer .",
"after a median follow-up of @ years , chemotherapy-irrespective of timing-significantly improved local control .",
"adjuvant chemotherapy did not improve survival , but the kaplan-meier curves diverged , suggesting possible delayed benefit .",
"here , we report the updated long-term results .",
"we randomly assigned patients with clinical stage t@ or t@ resectable rectal cancer to receive preoperative radiotherapy with or without concomitant chemotherapy before surgery followed by either adjuvant chemotherapy or surveillance .",
"randomisation was done using minimisation with factors of institution , sex , t stage , and distance from the tumour to the anal verge .",
"study coordinators , clinicians , and patients were aware of assignment .",
"radiotherapy consisted of @ gy to the posterior pelvis in @ fractions of @ gy over @ weeks .",
"each course of chemotherapy consisted of fluorouracil ( @ mg/m ( @ ) per day intravenous bolus ) and folinic acid ( leucovorin ; @ mg/m ( @ ) per day intravenous bolus ) .",
"for preoperative chemotherapy , two courses were given ( during weeks @ and @ of radiotherapy ) .",
"adjuvant chemotherapy was given in four cycles , every @ weeks .",
"the primary endpoint was overall survival .",
"this analysis was done by intention to treat .",
"the trial is registered with clinicaltrials.gov , number nct@ .",
"@ patients were randomly assigned to treatment between april , @ , and march , @ ( @ to preoperative radiotherapy and @ to each of the other three groups ) .",
"after a median follow-up of @ years ( iqr @-@ ) , @-year overall survival was @ % ( @ % ci @-@ ) for the preoperative radiotherapy group and @ % ( @-@ ) for the preoperative radiotherapy and chemotherapy group ( hr @ , @ % ci @-@ ; p = @ ) .",
"@-year overall survival was @ % ( @ % ci @-@ ) for the adjuvant chemotherapy group and @ % ( @-@ ) for the surveillance group ( hr @ , @ % ci @-@ , p = @ ) .",
"@-year disease-free survival was @ % ( @ % ci @-@ ) for the preoperative radiotherapy group and @ % ( @-@ ) for the preoperative radiotherapy and chemotherapy group ( hr @ , @ % ci @-@ ; p = @ ) .",
"@-year disease-free survival was @ % ( @ % ci @-@ ) for the adjuvant chemotherapy group and @ % ( @-@ ) for the surveillance group ( hr @ , @ % ci @-@ , p = @ ) .",
"at @ years , cumulative incidence of local relapse was @ % ( @ % ci @-@ ) with radiotherapy alone , @ % ( @-@ ) with neoadjuvant radiotherapy and chemotherapy , @ % ( @-@ ) with radiotherapy and adjuvant chemotherapy and @ % ( @-@ ) with both adjuvant and neoadjuvant chemotherapy ( p = @ ) .",
"there was no difference in cumulative incidence of distant metastases ( p = @ ) .",
"the frequency of long-term side-effects did not differ between the four groups ( p = @ ) .",
"adjuvant fluorouracil-based chemotherapy after preoperative radiotherapy ( with or without chemotherapy ) does not affect disease-free survival or overall survival .",
"our trial does not support the current practice of adjuvant chemotherapy after preoperative radiotherapy with or without chemotherapy .",
"new treatment strategies incorporating neoadjuvant chemotherapy are required .",
"eortc , us national cancer institute , programme hospitalier de recherche clinique , ligue contre le cancer comit du doubs ."
] | eortc trial @ examined the addition of preoperative or postoperative chemotherapy to preoperative radiotherapy in patients with rectal cancer . after a median follow-up of @ years , chemotherapy-irrespective of timing-significantly improved local control . adjuvant chemotherapy did not improve survival , but the kaplan-meier curves diverged , suggesting possible delayed benefit . here , we report the updated long-term results . we randomly assigned patients with clinical stage t@ or t@ resectable rectal cancer to receive preoperative radiotherapy with or without concomitant chemotherapy before surgery followed by either adjuvant chemotherapy or surveillance . randomisation was done using minimisation with factors of institution , sex , t stage , and distance from the tumour to the anal verge . study coordinators , clinicians , and patients were aware of assignment . radiotherapy consisted of @ gy to the posterior pelvis in @ fractions of @ gy over @ weeks . each course of chemotherapy consisted of fluorouracil ( @ mg/m ( @ ) per day intravenous bolus ) and folinic acid ( leucovorin ; @ mg/m ( @ ) per day intravenous bolus ) . for preoperative chemotherapy , two courses were given ( during weeks @ and @ of radiotherapy ) . adjuvant chemotherapy was given in four cycles , every @ weeks . the primary endpoint was overall survival . this analysis was done by intention to treat . the trial is registered with clinicaltrials.gov , number nct@ . @ patients were randomly assigned to treatment between april , @ , and march , @ ( @ to preoperative radiotherapy and @ to each of the other three groups ) . after a median follow-up of @ years ( iqr @-@ ) , @-year overall survival was @ % ( @ % ci @-@ ) for the preoperative radiotherapy group and @ % ( @-@ ) for the preoperative radiotherapy and chemotherapy group ( hr @ , @ % ci @-@ ; p = @ ) . @-year overall survival was @ % ( @ % ci @-@ ) for the adjuvant chemotherapy group and @ % ( @-@ ) for the surveillance group ( hr @ , @ % ci @-@ , p = @ ) . @-year disease-free survival was @ % ( @ % ci @-@ ) for the preoperative radiotherapy group and @ % ( @-@ ) for the preoperative radiotherapy and chemotherapy group ( hr @ , @ % ci @-@ ; p = @ ) . @-year disease-free survival was @ % ( @ % ci @-@ ) for the adjuvant chemotherapy group and @ % ( @-@ ) for the surveillance group ( hr @ , @ % ci @-@ , p = @ ) . at @ years , cumulative incidence of local relapse was @ % ( @ % ci @-@ ) with radiotherapy alone , @ % ( @-@ ) with neoadjuvant radiotherapy and chemotherapy , @ % ( @-@ ) with radiotherapy and adjuvant chemotherapy and @ % ( @-@ ) with both adjuvant and neoadjuvant chemotherapy ( p = @ ) . there was no difference in cumulative incidence of distant metastases ( p = @ ) . the frequency of long-term side-effects did not differ between the four groups ( p = @ ) . adjuvant fluorouracil-based chemotherapy after preoperative radiotherapy ( with or without chemotherapy ) does not affect disease-free survival or overall survival . our trial does not support the current practice of adjuvant chemotherapy after preoperative radiotherapy with or without chemotherapy . new treatment strategies incorporating neoadjuvant chemotherapy are required . eortc , us national cancer institute , programme hospitalier de recherche clinique , ligue contre le cancer comit du doubs . | 24,440,473 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"a variety of techniques exist for the treatment of patients with great saphenous vein ( gsv ) varicosities .",
"few data exist on the long-term outcomes of these interventions .",
"patients undergoing conventional surgery , endovenous laser ablation ( evla ) and ultrasound-guided foam sclerotherapy ( ugfs ) for gsv varicose veins were followed up for @ years .",
"primary outcome was obliteration or absence of the treated gsv segment ; secondary outcomes were absence of gsv reflux , and change in chronic venous insufficiency quality-of-life questionnaire ( civiq ) and euroqol - @d ( eq-@d ) scores .",
"a total of @ legs were included ( @ conventional surgery , @ evla , @ ugfs ) , @ ( @ per cent ) of which were evaluated at final follow-up .",
"at @ years , kaplan-meier estimates of obliteration or absence of the gsv were @ ( @ per cent c.i. @ to @ ) , @ ( @ to @ ) and @ ( @ to @ ) per cent in the conventional surgery , evla and ugfs groups respectively .",
"absence of above-knee gsv reflux was found in @ ( @ to @ ) , @ ( @ to @ ) and @ ( @ to @ ) per cent respectively .",
"civiq scores deteriorated over time in patients in the ugfs group ( @ increase per year , @ per cent c.i. @ to @ ) , and were significantly worse than those in the evla group ( -@ decrease per year , @ per cent c.i. -@ to @ ) ( p = @ ) .",
"civiq scores for the conventional surgery group did not differ from those in the evla and ugfs groups ( @ increase per year , @ per cent c.i. -@ to @ ) .",
"eq-@d scores improved equally in all groups .",
"evla and conventional surgery were more effective than ugfs in obliterating the gsv @ years after intervention .",
"ugfs was associated with substantial rates of gsv reflux and inferior civiq scores compared with evla and conventional surgery .",
"nct@ ( http://www.clinicaltrials.gov ) ."
] | a variety of techniques exist for the treatment of patients with great saphenous vein ( gsv ) varicosities . few data exist on the long-term outcomes of these interventions . patients undergoing conventional surgery , endovenous laser ablation ( evla ) and ultrasound-guided foam sclerotherapy ( ugfs ) for gsv varicose veins were followed up for @ years . primary outcome was obliteration or absence of the treated gsv segment ; secondary outcomes were absence of gsv reflux , and change in chronic venous insufficiency quality-of-life questionnaire ( civiq ) and euroqol - @d ( eq-@d ) scores . a total of @ legs were included ( @ conventional surgery , @ evla , @ ugfs ) , @ ( @ per cent ) of which were evaluated at final follow-up . at @ years , kaplan-meier estimates of obliteration or absence of the gsv were @ ( @ per cent c.i. @ to @ ) , @ ( @ to @ ) and @ ( @ to @ ) per cent in the conventional surgery , evla and ugfs groups respectively . absence of above-knee gsv reflux was found in @ ( @ to @ ) , @ ( @ to @ ) and @ ( @ to @ ) per cent respectively . civiq scores deteriorated over time in patients in the ugfs group ( @ increase per year , @ per cent c.i. @ to @ ) , and were significantly worse than those in the evla group ( -@ decrease per year , @ per cent c.i. -@ to @ ) ( p = @ ) . civiq scores for the conventional surgery group did not differ from those in the evla and ugfs groups ( @ increase per year , @ per cent c.i. -@ to @ ) . eq-@d scores improved equally in all groups . evla and conventional surgery were more effective than ugfs in obliterating the gsv @ years after intervention . ugfs was associated with substantial rates of gsv reflux and inferior civiq scores compared with evla and conventional surgery . nct@ ( http://www.clinicaltrials.gov ) . | 26,132,315 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"chemotherapy-induced peripheral neuropathy ( cipn ) occurs in as high as @ % of patients receiving certain types of chemotherapy agents .",
"the fda has yet to approve a therapy for cipn .",
"the aim of this multicenter , phase iii , randomized , double-blind , placebo-controlled trial was to investigate the efficacy of @ % ketamine plus @ % amitriptyline ( ka ) cream for reducing cipn .",
"cancer survivors who completed chemotherapy at least @ month prior and had cipn ( > @ out of @ ) were enrolled ( n = @ ) .",
"cipn was assessed using average scores from a @-day daily diary that asks patients to rate the average `` pain , numbness , or tingling in -lsb- their -rsb- hands and feet over the past @ h '' on an @-point numeric rating scale at baseline and @ weeks post intervention .",
"ancova was used to measure differences in @-week cipn with effects including baseline cipn , ka treatment arm , and previous taxane therapy ( y/n ) .",
"the ka treatment showed no effect on @-week cipn scores ( adjusted mean difference = -@ , p = @ ) .",
"this study suggests that ka cream does not decrease cipn symptoms in cancer survivors ."
] | chemotherapy-induced peripheral neuropathy ( cipn ) occurs in as high as @ % of patients receiving certain types of chemotherapy agents . the fda has yet to approve a therapy for cipn . the aim of this multicenter , phase iii , randomized , double-blind , placebo-controlled trial was to investigate the efficacy of @ % ketamine plus @ % amitriptyline ( ka ) cream for reducing cipn . cancer survivors who completed chemotherapy at least @ month prior and had cipn ( > @ out of @ ) were enrolled ( n = @ ) . cipn was assessed using average scores from a @-day daily diary that asks patients to rate the average `` pain , numbness , or tingling in -lsb- their -rsb- hands and feet over the past @ h '' on an @-point numeric rating scale at baseline and @ weeks post intervention . ancova was used to measure differences in @-week cipn with effects including baseline cipn , ka treatment arm , and previous taxane therapy ( y/n ) . the ka treatment showed no effect on @-week cipn scores ( adjusted mean difference = -@ , p = @ ) . this study suggests that ka cream does not decrease cipn symptoms in cancer survivors . | 24,531,792 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"CONCLUSIONS"
] |
[
"this study investigated the long-term safety of rivastigmine ( @ mg/d capsules , @ mg/@ h patch ) and effects on motor symptoms in patients with mild-to-moderately severe parkinson disease dementia .",
"this was a @-week , prospective , open-label , randomized study in patients aged @ to @ years .",
"primary outcomes included incidence of , and discontinuation due to , predefined adverse events ( aes ) potentially arising from worsening of parkinson disease motor symptoms with capsules .",
"secondary outcomes included frequency of aes/serious aes .",
"efficacy outcomes included alzheimer 's disease cooperative study-activities of daily living ( adcs-adl ) , neuropsychiatric inventory ( npi-@ ) , and mattis dementia rating scale ( mdrs ) .",
"five hundred eighty-three patients were randomized to rivastigmine capsules ( n = @ ) or patch ( n = @ ) .",
"incidence of predefined aes was @ % for capsules , @ % for patch ; discontinuation due to worsening of motor symptoms was @ % and @ % , respectively .",
"most common aes were nausea ( capsules , @ % ; patch , @ % ) , tremor ( @ % ; @ % ) , fall ( @ % ; @ % ) , vomiting ( @ % ; @ % ) , and application site erythema ( @ % ; @ % ) .",
"significant efficacy in favor of capsules was observed at weeks @ to @ on mdrs ; @ and @ on npi-@ ; weeks @ and @ on adcs-adl .",
"in patients with mini-mental state examination ( mmse ) greater than @ , no differences in efficacy on mdrs and adcs-adl were observed at any time point ; significant differences in favor of capsules were maintained in patients with mmse less than or equal to @ .",
"this study supports the long-term safety of rivastigmine in parkinson disease dementia .",
"the rate of worsening of motor symptoms was in the range expected due to the natural progression of parkinson disease , no new or unexpected safety issues emerged in the long-term ."
] | this study investigated the long-term safety of rivastigmine ( @ mg/d capsules , @ mg/@ h patch ) and effects on motor symptoms in patients with mild-to-moderately severe parkinson disease dementia . this was a @-week , prospective , open-label , randomized study in patients aged @ to @ years . primary outcomes included incidence of , and discontinuation due to , predefined adverse events ( aes ) potentially arising from worsening of parkinson disease motor symptoms with capsules . secondary outcomes included frequency of aes/serious aes . efficacy outcomes included alzheimer 's disease cooperative study-activities of daily living ( adcs-adl ) , neuropsychiatric inventory ( npi-@ ) , and mattis dementia rating scale ( mdrs ) . five hundred eighty-three patients were randomized to rivastigmine capsules ( n = @ ) or patch ( n = @ ) . incidence of predefined aes was @ % for capsules , @ % for patch ; discontinuation due to worsening of motor symptoms was @ % and @ % , respectively . most common aes were nausea ( capsules , @ % ; patch , @ % ) , tremor ( @ % ; @ % ) , fall ( @ % ; @ % ) , vomiting ( @ % ; @ % ) , and application site erythema ( @ % ; @ % ) . significant efficacy in favor of capsules was observed at weeks @ to @ on mdrs ; @ and @ on npi-@ ; weeks @ and @ on adcs-adl . in patients with mini-mental state examination ( mmse ) greater than @ , no differences in efficacy on mdrs and adcs-adl were observed at any time point ; significant differences in favor of capsules were maintained in patients with mmse less than or equal to @ . this study supports the long-term safety of rivastigmine in parkinson disease dementia . the rate of worsening of motor symptoms was in the range expected due to the natural progression of parkinson disease , no new or unexpected safety issues emerged in the long-term . | 24,434,526 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"this study delineates activities of daily living ( adl ) and instrumental activities of daily living ( iadl ) black-white disparity trends by age , period , and cohort ( apc ) and explores sociodemographic contributors of cohort-based disparity trends .",
"we utilized multiple cross-sectional waves of national health interview survey data ( @-@ ) to describe apc trends of adl and iadl disparities using a cross-classified random effect model .",
"further , we decomposed the cohort-based disparity trends using fairlie 's decomposition method for nonlinear outcomes .",
"the crossover adl and iadl disparities ( whites > blacks ) occurring at age @ increased with age and reached a plateau at age of @ , whereas period-based adl and iadl disparities remained constant for the past @ decades .",
"the cohort disparity trends for both disabilities showed a decline with each successive cohort except for adl disparity among women .",
"we examined the role of aging on racial disparity in disability and found support for the racial crossover effect .",
"further , the racial disparity in disability will disappear should the observed pattern of declining cohort-based adl and iadl disparities persist .",
"although education , income , and marital status are important sociodemographic contributors to cohort disparity trends , future studies should investigate individual behavioral health determinants and cohort-specific characteristics that explain the cohort-based racial difference in adl and iadl disabilities ."
] | this study delineates activities of daily living ( adl ) and instrumental activities of daily living ( iadl ) black-white disparity trends by age , period , and cohort ( apc ) and explores sociodemographic contributors of cohort-based disparity trends . we utilized multiple cross-sectional waves of national health interview survey data ( @-@ ) to describe apc trends of adl and iadl disparities using a cross-classified random effect model . further , we decomposed the cohort-based disparity trends using fairlie 's decomposition method for nonlinear outcomes . the crossover adl and iadl disparities ( whites > blacks ) occurring at age @ increased with age and reached a plateau at age of @ , whereas period-based adl and iadl disparities remained constant for the past @ decades . the cohort disparity trends for both disabilities showed a decline with each successive cohort except for adl disparity among women . we examined the role of aging on racial disparity in disability and found support for the racial crossover effect . further , the racial disparity in disability will disappear should the observed pattern of declining cohort-based adl and iadl disparities persist . although education , income , and marital status are important sociodemographic contributors to cohort disparity trends , future studies should investigate individual behavioral health determinants and cohort-specific characteristics that explain the cohort-based racial difference in adl and iadl disabilities . | 24,986,183 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"randomized trials have not shown major survival benefits when induction chemotherapy plus standard therapy is compared with standard therapy alone in patients with oral squamous cell carcinoma ( oscc ) .",
"induction chemotherapy is likely to be effective for biologically distinct subgroups and biomarker development may lead to identification of patients whose tumors are likely to respond to a particular treatment .",
"we evaluated immunohistochemical staining for gdf@ in pretreatment biopsy specimens of @ of @ oscc patients who were treated in a prospective , randomized , phase iii trial on induction chemotherapy including docetaxel , cisplatin and @-fluorouracil ( tpf ) .",
"relationship between gdf@ intervention and cell proliferation , migration , invasion , colony formation and tumorigenicity was analyzed using in vitro and in vivo oscc models .",
"low gdf@ expression predicted a better survival in oscc patients , especially overall survival -lsb- p = @ , hazard ratio ( hr ) = @ -rsb- and distant metastasis-free survival ( dmfs ; p = @ , hr = @ ) .",
"cn + patients with low gdf@ expression benefitted from induction tpf in overall survival ( p = @ , hr = @ ) and dmfs ( p = @ , hr = @ ) , cn - patients with high gdf@ expression benefitted from induction tpf in overall survival ( p = @ , hr = @ ) , disease-free survival ( p = @ , hr = @ ) , locoregional recurrence-free survival ( p = @ , hr = @ ) and dmfs ( p = @ , hr = @ ) .",
"decreased gdf@ expression in oscc lines significantly inhibited cell proliferation , migration , invasion , colony formation and tumorigenesis through increased phosphorylation of akt and erk@/@ ( p < @ ) .",
"likewise , overexpression of gdf@ significantly promoted cell proliferation , migration , invasion and colony formation through decreased phosphorylation of akt and erk@/@ ( p < @ ) .",
"gdf@ expression can be used as a prognostic biomarker for oscc , and as a predictive biomarker for benefitting from tpf induction chemotherapy .",
"gdf@ promotes tumorigenesis and progression through phosphorylation of akt and erk@/@ in oscc .",
"the clinical trial in this study was registered with www.clinicaltrials.gov ( nct@ ) ."
] | randomized trials have not shown major survival benefits when induction chemotherapy plus standard therapy is compared with standard therapy alone in patients with oral squamous cell carcinoma ( oscc ) . induction chemotherapy is likely to be effective for biologically distinct subgroups and biomarker development may lead to identification of patients whose tumors are likely to respond to a particular treatment . we evaluated immunohistochemical staining for gdf@ in pretreatment biopsy specimens of @ of @ oscc patients who were treated in a prospective , randomized , phase iii trial on induction chemotherapy including docetaxel , cisplatin and @-fluorouracil ( tpf ) . relationship between gdf@ intervention and cell proliferation , migration , invasion , colony formation and tumorigenicity was analyzed using in vitro and in vivo oscc models . low gdf@ expression predicted a better survival in oscc patients , especially overall survival -lsb- p = @ , hazard ratio ( hr ) = @ -rsb- and distant metastasis-free survival ( dmfs ; p = @ , hr = @ ) . cn + patients with low gdf@ expression benefitted from induction tpf in overall survival ( p = @ , hr = @ ) and dmfs ( p = @ , hr = @ ) , cn - patients with high gdf@ expression benefitted from induction tpf in overall survival ( p = @ , hr = @ ) , disease-free survival ( p = @ , hr = @ ) , locoregional recurrence-free survival ( p = @ , hr = @ ) and dmfs ( p = @ , hr = @ ) . decreased gdf@ expression in oscc lines significantly inhibited cell proliferation , migration , invasion , colony formation and tumorigenesis through increased phosphorylation of akt and erk@/@ ( p < @ ) . likewise , overexpression of gdf@ significantly promoted cell proliferation , migration , invasion and colony formation through decreased phosphorylation of akt and erk@/@ ( p < @ ) . gdf@ expression can be used as a prognostic biomarker for oscc , and as a predictive biomarker for benefitting from tpf induction chemotherapy . gdf@ promotes tumorigenesis and progression through phosphorylation of akt and erk@/@ in oscc . the clinical trial in this study was registered with www.clinicaltrials.gov ( nct@ ) . | 24,669,014 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"the continued use of angiotensin-converting enzyme inhibitors ( aceis ) and angiotensin ii subtype i receptor antagonists ( arbs ) medications in the preoperative period has been reported to be associated with intraoperative hypotension that can be unresponsive to pressor drugs .",
"as a result , several investigators suggested discontinuation of these medications before scheduled surgery but did not report on unintended consequences that might result from discontinuation .",
"we conducted a prospective , single-blind , randomized trial to observe the effect of the medications on preoperative arterial blood pressure recordings in patients presenting for ambulatory and same-day surgery .",
"six hundred forty-four patients presenting for ambulatory and same-day surgery were enrolled prospectively between @ and @ and randomly assigned to @ groups based on continuation or discontinuation of aceis and arbs .",
"an intention-to-treat analysis was performed .",
"the primary outcome was presence of hypertension ( htn ) immediately before surgery .",
"secondary outcomes included surgical cancellations due to htn , prolongation of hospitalization , adverse clinical events , and htn in the postoperative period .",
"data for @ patients were analyzed .",
"there were @ patients in the discontinuation group and @ patients in the continuation group .",
"discontinuation of aceis and arbs on the day of surgery was not associated with increased prevalence of preoperative htn ( p = @ ) .",
"the upper bound of a @ % confidence interval for the difference in prevalence of stage @ and @ htn between study arms indicates that discontinuation of study medication is unlikely to be associated with an increase in stage @ htn of > @ percentage points and in stage @ htn of no > @ percentage points .",
"discontinuation was not associated with an increase in postoperative htn , with prolongation of hospitalization or with adverse clinical events .",
"discontinuing aceis and arbs in patients on the day of surgery did not result in a substantively increased incidence of pre - or postoperative htn compared with patients who continued these medications on the day of surgery .",
"the results provide an evidentiary basis for the safety of discontinuing aceis and arbs on the day of surgery without increasing adverse hemodynamic outcomes ."
] | the continued use of angiotensin-converting enzyme inhibitors ( aceis ) and angiotensin ii subtype i receptor antagonists ( arbs ) medications in the preoperative period has been reported to be associated with intraoperative hypotension that can be unresponsive to pressor drugs . as a result , several investigators suggested discontinuation of these medications before scheduled surgery but did not report on unintended consequences that might result from discontinuation . we conducted a prospective , single-blind , randomized trial to observe the effect of the medications on preoperative arterial blood pressure recordings in patients presenting for ambulatory and same-day surgery . six hundred forty-four patients presenting for ambulatory and same-day surgery were enrolled prospectively between @ and @ and randomly assigned to @ groups based on continuation or discontinuation of aceis and arbs . an intention-to-treat analysis was performed . the primary outcome was presence of hypertension ( htn ) immediately before surgery . secondary outcomes included surgical cancellations due to htn , prolongation of hospitalization , adverse clinical events , and htn in the postoperative period . data for @ patients were analyzed . there were @ patients in the discontinuation group and @ patients in the continuation group . discontinuation of aceis and arbs on the day of surgery was not associated with increased prevalence of preoperative htn ( p = @ ) . the upper bound of a @ % confidence interval for the difference in prevalence of stage @ and @ htn between study arms indicates that discontinuation of study medication is unlikely to be associated with an increase in stage @ htn of > @ percentage points and in stage @ htn of no > @ percentage points . discontinuation was not associated with an increase in postoperative htn , with prolongation of hospitalization or with adverse clinical events . discontinuing aceis and arbs in patients on the day of surgery did not result in a substantively increased incidence of pre - or postoperative htn compared with patients who continued these medications on the day of surgery . the results provide an evidentiary basis for the safety of discontinuing aceis and arbs on the day of surgery without increasing adverse hemodynamic outcomes . | 24,681,657 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to evaluate efficacy and safety of superior hypogastric plexus neurolysis ( shn ) for treatment of interstitial cystitis ( ic ) - bladder pain syndrome ( bps ) in comparison with bladder hydrodistention ( hd ) .",
"in a prospective study , @ female patients were randomly allocated to receive either shn or hd .",
"patients were evaluated by recording the o'leary-sant ic symptom indices , ic problem indices , pain visual analog scale ( vas ) , number of daytime frequency , and nocturia .",
"pressure flow study was conducted for all patients .",
"intraoperative and postoperative changes and adverse events were recorded .",
"basal ic symptom indices , ic problem indices , and vas scores were comparable between both groups ( p = @ , @ , and @ , respectively ) .",
"there was no statistically significant difference between both groups with respect to urodynamic parameters .",
"only pain vas at first week was improved in shn in comparison with hd ( p = @ ) .",
"thereafter , all parameters were significantly improved in favor of the hd group at @ - and @-week visits .",
"adverse events in both groups were ranked as grade @ clavien-dindo classification including transient hematuria in the hd group and transient back ache in the shn group .",
"despite effective pain control in cases with ic-bps after shn , it lacks durability .",
"it seems that shn in its current form is not to be a suitable line of treatment for ic-bps .",
"multimodality treatment would be needed for proper control of patients ' symptoms ."
] | to evaluate efficacy and safety of superior hypogastric plexus neurolysis ( shn ) for treatment of interstitial cystitis ( ic ) - bladder pain syndrome ( bps ) in comparison with bladder hydrodistention ( hd ) . in a prospective study , @ female patients were randomly allocated to receive either shn or hd . patients were evaluated by recording the o'leary-sant ic symptom indices , ic problem indices , pain visual analog scale ( vas ) , number of daytime frequency , and nocturia . pressure flow study was conducted for all patients . intraoperative and postoperative changes and adverse events were recorded . basal ic symptom indices , ic problem indices , and vas scores were comparable between both groups ( p = @ , @ , and @ , respectively ) . there was no statistically significant difference between both groups with respect to urodynamic parameters . only pain vas at first week was improved in shn in comparison with hd ( p = @ ) . thereafter , all parameters were significantly improved in favor of the hd group at @ - and @-week visits . adverse events in both groups were ranked as grade @ clavien-dindo classification including transient hematuria in the hd group and transient back ache in the shn group . despite effective pain control in cases with ic-bps after shn , it lacks durability . it seems that shn in its current form is not to be a suitable line of treatment for ic-bps . multimodality treatment would be needed for proper control of patients ' symptoms . | 25,917,730 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"recent studies show that cerebral - amyloid ( a ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals .",
"to examine the association between measures of arterial stiffness and change in a deposition over time .",
"deposition of a was determined in a longitudinal observational study of aging by positron emission tomography using the pittsburgh compound b twice @ years apart in @ nondemented individuals @ years and older .",
"arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan .",
"all measures were performed under standardized conditions .",
"pulse wave velocity ( pwv ) was measured in the central ( carotid-femoral and heart-femoral pwv ) , peripheral ( femoral-ankle pwv ) , and mixed ( brachial-ankle pwv ) vascular beds .",
"the change in a deposition over @ years was calculated from the @ individuals with repeat a-positron emission tomography .",
"the proportion of a-positive individuals increased from @ % at baseline to @ % at follow-up .",
"brachial-ankle pwv was significantly higher among a-positive participants at baseline and follow-up .",
"femoral-ankle pwv was only higher among a-positive participants at follow-up .",
"measures of central stiffness and blood pressure were not associated with a status at baseline or follow-up , but central stiffness was associated with a change in a deposition over time .",
"each standard deviation increase in central stiffness ( carotid-femoral pwv , p = @ ; heart-femoral pwv , p = @ ) was linked with increases in a deposition over @ years .",
"this study showed that a deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of a in the brain , especially in this age group .",
"the association between a deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral a deposition ."
] | recent studies show that cerebral - amyloid ( a ) deposition is associated with blood pressure and measures of arterial stiffness in nondemented individuals . to examine the association between measures of arterial stiffness and change in a deposition over time . deposition of a was determined in a longitudinal observational study of aging by positron emission tomography using the pittsburgh compound b twice @ years apart in @ nondemented individuals @ years and older . arterial stiffness was measured with a noninvasive and automated waveform analyzer at the time closest to the second positron emission tomography scan . all measures were performed under standardized conditions . pulse wave velocity ( pwv ) was measured in the central ( carotid-femoral and heart-femoral pwv ) , peripheral ( femoral-ankle pwv ) , and mixed ( brachial-ankle pwv ) vascular beds . the change in a deposition over @ years was calculated from the @ individuals with repeat a-positron emission tomography . the proportion of a-positive individuals increased from @ % at baseline to @ % at follow-up . brachial-ankle pwv was significantly higher among a-positive participants at baseline and follow-up . femoral-ankle pwv was only higher among a-positive participants at follow-up . measures of central stiffness and blood pressure were not associated with a status at baseline or follow-up , but central stiffness was associated with a change in a deposition over time . each standard deviation increase in central stiffness ( carotid-femoral pwv , p = @ ; heart-femoral pwv , p = @ ) was linked with increases in a deposition over @ years . this study showed that a deposition increases with age in nondemented individuals and that arterial stiffness is strongly associated with the progressive deposition of a in the brain , especially in this age group . the association between a deposition changes over time and generalized arterial stiffness indicated a relationship between the severity of subclinical vascular disease and progressive cerebral a deposition . | 24,687,165 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"this study investigates measures of mindfulness meditation ( mm ) as a mental practice , in which a resting but alert state of mind is maintained .",
"a population of older people with high stress level participated in this study , while electroencephalographic ( eeg ) and respiration signals were recorded during a mm intervention .",
"the physiological signals during meditation and control conditions were analyzed with signal processing .",
"eeg and respiration data were collected and analyzed on @ novice meditators after a @-week meditation intervention .",
"collected data were analyzed with spectral analysis , phase analysis and classification to evaluate an objective marker for meditation .",
"different frequency bands showed differences in meditation and control conditions .",
"furthermore , we established a classifier using eeg and respiration signals with a higher accuracy ( @ % ) at discriminating between meditation and control conditions than a classifier using the eeg signal only ( @ % ) .",
"support vector machine ( svm ) classifier with eeg and respiration feature vector is a viable objective marker for meditation ability .",
"this classifier should be able to quantify different levels of meditation depth and meditation experience in future studies ."
] | this study investigates measures of mindfulness meditation ( mm ) as a mental practice , in which a resting but alert state of mind is maintained . a population of older people with high stress level participated in this study , while electroencephalographic ( eeg ) and respiration signals were recorded during a mm intervention . the physiological signals during meditation and control conditions were analyzed with signal processing . eeg and respiration data were collected and analyzed on @ novice meditators after a @-week meditation intervention . collected data were analyzed with spectral analysis , phase analysis and classification to evaluate an objective marker for meditation . different frequency bands showed differences in meditation and control conditions . furthermore , we established a classifier using eeg and respiration signals with a higher accuracy ( @ % ) at discriminating between meditation and control conditions than a classifier using the eeg signal only ( @ % ) . support vector machine ( svm ) classifier with eeg and respiration feature vector is a viable objective marker for meditation ability . this classifier should be able to quantify different levels of meditation depth and meditation experience in future studies . | 24,939,519 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"this randomised phase ii trial aimed to compare efficacy of the irreversible erbb family blocker , afatinib , with cetuximab in patients with kras wild-type metastatic colorectal adenocarcinoma ( mcrc ) with progression following oxaliplatin - and irinotecan-based regimens .",
"efficacy in patients with kras mutations was also evaluated .",
"patients with kras wild-type tumours were randomised @:@ to afatinib ( @ mg/day , increasing to @ mg/day if minimal toxicity ) or cetuximab weekly ( @ mg/m@ loading dose , then @ mg/m@/week ) according to number of previous chemotherapy lines .",
"all patients with kras-mutated tumours received afatinib .",
"primary end-points were objective response ( or ) for the wild-type group and disease control for the kras-mutated group .",
"secondary end-points were progression-free survival ( pfs ) and overall survival ( os ) .",
"patients with kras wild-type tumours ( n = @ ) received afatinib ( n = @ ) or cetuximab ( n = @ ) .",
"unconfirmed and confirmed ors were @ % and @ % for afatinib versus @ % and @ % for cetuximab ( odds ratio : @ -lsb- p = @ -rsb- and < @ , respectively ) .",
"median pfs was @ and @ days for afatinib and cetuximab , respectively .",
"median os was @ days with afatinib but not reached for cetuximab .",
"in the kras-mutated group ( n = @ ) , five ( @ % ) patients achieved confirmed disease control ( stable disease ; p = @ -lsb- comparison versus @ % -rsb- ) ; no ors were reported .",
"median pfs and os were @ and @days , respectively .",
"most frequent treatment-related adverse events were diarrhoea and rash across groups .",
"the efficacy of afatinib was inferior to cetuximab in patients with kras wild-type mcrc .",
"in patients with kras-mutated tumours , disease control was modest with afatinib .",
"afatinib had a manageable safety profile ."
] | this randomised phase ii trial aimed to compare efficacy of the irreversible erbb family blocker , afatinib , with cetuximab in patients with kras wild-type metastatic colorectal adenocarcinoma ( mcrc ) with progression following oxaliplatin - and irinotecan-based regimens . efficacy in patients with kras mutations was also evaluated . patients with kras wild-type tumours were randomised @:@ to afatinib ( @ mg/day , increasing to @ mg/day if minimal toxicity ) or cetuximab weekly ( @ mg/m@ loading dose , then @ mg/m@/week ) according to number of previous chemotherapy lines . all patients with kras-mutated tumours received afatinib . primary end-points were objective response ( or ) for the wild-type group and disease control for the kras-mutated group . secondary end-points were progression-free survival ( pfs ) and overall survival ( os ) . patients with kras wild-type tumours ( n = @ ) received afatinib ( n = @ ) or cetuximab ( n = @ ) . unconfirmed and confirmed ors were @ % and @ % for afatinib versus @ % and @ % for cetuximab ( odds ratio : @ -lsb- p = @ -rsb- and < @ , respectively ) . median pfs was @ and @ days for afatinib and cetuximab , respectively . median os was @ days with afatinib but not reached for cetuximab . in the kras-mutated group ( n = @ ) , five ( @ % ) patients achieved confirmed disease control ( stable disease ; p = @ -lsb- comparison versus @ % -rsb- ) ; no ors were reported . median pfs and os were @ and @days , respectively . most frequent treatment-related adverse events were diarrhoea and rash across groups . the efficacy of afatinib was inferior to cetuximab in patients with kras wild-type mcrc . in patients with kras-mutated tumours , disease control was modest with afatinib . afatinib had a manageable safety profile . | 25,441,408 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"heart failure and left ventricular systolic dysfunction ( lvsd ) are common in patients with permanent pacemakers , but whether right ventricular ( rv ) pacing is contributory or merely a bystander in patients with more severe cardiac disease is controversial .",
"the aim of the present study was to determine whether reprogramming of existing pacemakers to reduce rv pacing is safe and leads to improvements in cardiac function .",
"this was a prospective service evaluation of the effects of optimising pacemaker programming to avoid rv pacing in @ consecutive attendees of a teaching hospital pacemaker clinic without complete heart block .",
"the main outcome measures were left ventricular ejection fraction ( lvef ) , n-terminal pro-b-type natriuretic peptide ( nt-pro-bnp ) levels , quality of life and cardiopulmonary exercise testing at baseline and after @ months .",
"at @ months , the protocol reduced absolute rv pacing by a mean of @ % ( @ % ci @ % to @ % ) ( p < @ from baseline ) and resulted in a mean absolute improvement in lvef of @ % ( @ % to @ % ) ( p < @ from baseline ) but no reduction in exercise capacity , nt-pro-bnp or quality of life .",
"there was a relationship between the magnitude of change in ef and the reduction in rv pacing ( p = @ ) and changes in nt-pro-bnp seemed to relate to change in rv pacing ( p = @ ) .",
"programming standard pacemakers to avoid rv pacing is safe , does not adversely affect patients ' symptoms or quality of life and is associated with improved lv function , related to the reductions in rv pacing percentage ."
] | heart failure and left ventricular systolic dysfunction ( lvsd ) are common in patients with permanent pacemakers , but whether right ventricular ( rv ) pacing is contributory or merely a bystander in patients with more severe cardiac disease is controversial . the aim of the present study was to determine whether reprogramming of existing pacemakers to reduce rv pacing is safe and leads to improvements in cardiac function . this was a prospective service evaluation of the effects of optimising pacemaker programming to avoid rv pacing in @ consecutive attendees of a teaching hospital pacemaker clinic without complete heart block . the main outcome measures were left ventricular ejection fraction ( lvef ) , n-terminal pro-b-type natriuretic peptide ( nt-pro-bnp ) levels , quality of life and cardiopulmonary exercise testing at baseline and after @ months . at @ months , the protocol reduced absolute rv pacing by a mean of @ % ( @ % ci @ % to @ % ) ( p < @ from baseline ) and resulted in a mean absolute improvement in lvef of @ % ( @ % to @ % ) ( p < @ from baseline ) but no reduction in exercise capacity , nt-pro-bnp or quality of life . there was a relationship between the magnitude of change in ef and the reduction in rv pacing ( p = @ ) and changes in nt-pro-bnp seemed to relate to change in rv pacing ( p = @ ) . programming standard pacemakers to avoid rv pacing is safe , does not adversely affect patients ' symptoms or quality of life and is associated with improved lv function , related to the reductions in rv pacing percentage . | 24,430,095 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"new technologies could facilitate changes in lifestyle and improve public health .",
"however , no large randomized , controlled studies providing scientific evidence of the benefits of their use have been made .",
"the aims of this study are to develop and validate a smartphone application , and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the mediterranean diet and to physical activity .",
"an evaluation is also made of the effect of modifying habits upon vascular structure and function , and therefore on arterial aging .",
"a randomized , double-blind , multicenter , parallel group clinical trial will be carried out .",
"a total of @ subjects under @years of age from the evident trial will be included .",
"counseling common to both groups ( control and intervention ) will be provided on adaptation to the mediterranean diet and on physical activity .",
"the intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity , and will use the application for three months .",
"the main study endpoints will be the changes in physical activity , assessed by accelerometer and the @-day physical activity recall ( par ) interview , and adaptation to the mediterranean diet , as evaluated by an adherence questionnaire and a food frequency questionnaire ( ffq ) .",
"evaluation also will be made of vascular structure and function based on central arterial pressure , the radial augmentation index , pulse velocity , the cardio-ankle vascular index , and carotid intima-media thickness .",
"confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications , and may contribute to generalize their application in favor of improved population health .",
"clinical trials.gov identifier : nct@ ."
] | new technologies could facilitate changes in lifestyle and improve public health . however , no large randomized , controlled studies providing scientific evidence of the benefits of their use have been made . the aims of this study are to develop and validate a smartphone application , and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the mediterranean diet and to physical activity . an evaluation is also made of the effect of modifying habits upon vascular structure and function , and therefore on arterial aging . a randomized , double-blind , multicenter , parallel group clinical trial will be carried out . a total of @ subjects under @years of age from the evident trial will be included . counseling common to both groups ( control and intervention ) will be provided on adaptation to the mediterranean diet and on physical activity . the intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity , and will use the application for three months . the main study endpoints will be the changes in physical activity , assessed by accelerometer and the @-day physical activity recall ( par ) interview , and adaptation to the mediterranean diet , as evaluated by an adherence questionnaire and a food frequency questionnaire ( ffq ) . evaluation also will be made of vascular structure and function based on central arterial pressure , the radial augmentation index , pulse velocity , the cardio-ankle vascular index , and carotid intima-media thickness . confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications , and may contribute to generalize their application in favor of improved population health . clinical trials.gov identifier : nct@ . | 24,628,961 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"to investigate the safety , feasibility and preliminary efficacy of low-frequency repetitive transcranial magnetic stimulation ( rtms ) over the cerebellum in ataxic patients with acute posterior circulation stroke .",
"randomized , double-blind , sham-controlled pilot study .",
"thirty-two ataxic patients with posterior circulation stroke were randomized to real ( n = @ ) and sham ( n = @ ) rtms groups .",
"patients received @ @-min sessions of @ hz cerebellar rtms over @ consecutive days .",
"compliance and adverse events for the rtms sessions were checked .",
"the @-m walk test ( @mwt ) and berg balance scale ( bbs ) were completed before rtms , immediately and @ month after the last rtms session .",
"compliance with the rtms was @ % and no adverse events were reported in either group .",
"@mwt and bbs of real rtms group improved significantly ( p < @ ) .",
"percentage changes immediately after the last rtms session for time and steps in the @mwt and bbs in the real vs sham group were : -@ @ % vs -@ @ % , -@ @ % vs -@ @ % and @ @ % vs @ @ % , respectively .",
"this study demonstrated that @ hz rtms over the cerebellum is safe , feasible and may have a beneficial effect in ataxic patients with posterior circulation stroke ."
] | to investigate the safety , feasibility and preliminary efficacy of low-frequency repetitive transcranial magnetic stimulation ( rtms ) over the cerebellum in ataxic patients with acute posterior circulation stroke . randomized , double-blind , sham-controlled pilot study . thirty-two ataxic patients with posterior circulation stroke were randomized to real ( n = @ ) and sham ( n = @ ) rtms groups . patients received @ @-min sessions of @ hz cerebellar rtms over @ consecutive days . compliance and adverse events for the rtms sessions were checked . the @-m walk test ( @mwt ) and berg balance scale ( bbs ) were completed before rtms , immediately and @ month after the last rtms session . compliance with the rtms was @ % and no adverse events were reported in either group . @mwt and bbs of real rtms group improved significantly ( p < @ ) . percentage changes immediately after the last rtms session for time and steps in the @mwt and bbs in the real vs sham group were : -@ @ % vs -@ @ % , -@ @ % vs -@ @ % and @ @ % vs @ @ % , respectively . this study demonstrated that @ hz rtms over the cerebellum is safe , feasible and may have a beneficial effect in ataxic patients with posterior circulation stroke . | 24,658,396 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"because of its contribution to dietary diversity and to favorable intakes of micronutrients , including iron and zinc , meat is hypothesized to be a valuable complementary food for the infant and young child .",
"however , the evidence base remains limited .",
"to compare the difference in anthropometric measurements of rural chinese infants and toddlers @ to @ months of age who received a daily supplement of meat or cereal for @ months .",
"this cluster-randomized , controlled study provided a daily supplement of either meat ( n = @ , @ clusters ) or cereal ( n = @ , @ clusters ) starting as a first complementary food at @ months of age .",
"anthropometric measurements were assessed longitudinally .",
"after @ months of intervention , the meat group ( @ @ cm ) had greater ( p = @ ) linear growth than the cereal group ( @ @ cm ) and a smaller decrease in length-for-age z-score ( laz ) over time ( -@ @ in the meat group vs. -@ @ in the cereal group ) , after adjustment for baseline length , laz , maternal education , work status , and maternal height and weight .",
"linear growth was modestly greater in the meat group than in the cereal group .",
"laz was substantially negative at @ months , and the intervention did not prevent ongoing decline over the course of the study ."
] | because of its contribution to dietary diversity and to favorable intakes of micronutrients , including iron and zinc , meat is hypothesized to be a valuable complementary food for the infant and young child . however , the evidence base remains limited . to compare the difference in anthropometric measurements of rural chinese infants and toddlers @ to @ months of age who received a daily supplement of meat or cereal for @ months . this cluster-randomized , controlled study provided a daily supplement of either meat ( n = @ , @ clusters ) or cereal ( n = @ , @ clusters ) starting as a first complementary food at @ months of age . anthropometric measurements were assessed longitudinally . after @ months of intervention , the meat group ( @ @ cm ) had greater ( p = @ ) linear growth than the cereal group ( @ @ cm ) and a smaller decrease in length-for-age z-score ( laz ) over time ( -@ @ in the meat group vs. -@ @ in the cereal group ) , after adjustment for baseline length , laz , maternal education , work status , and maternal height and weight . linear growth was modestly greater in the meat group than in the cereal group . laz was substantially negative at @ months , and the intervention did not prevent ongoing decline over the course of the study . | 25,639,137 | [
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"poor sleep is prevalent in patients with systemic inflammatory disorders , including rheumatoid arthritis , and , in addition to fatigue , pain , depression and inflammation , is associated with an increased risk of co-morbidity and all-cause mortality .",
"whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue , no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis .",
"the aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep , assessed both objectively and subjectively in patients with rheumatoid arthritis .",
"a randomized controlled trial including @ patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group .",
"the intervention consists of @ session intermittent aerobic exercise training on a bicycle ergometer three times a week .",
"patients are evaluated according to objective changes in sleep as measured by polysomnography ( primary outcome ) .",
"secondary outcomes include changes in subjective sleep quality and sleep disturbances , fatigue , pain , depressive symptoms , physical function , health-related quality of life and cardiorespiratory fitness .",
"this trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis , which is considered important in promotion of health and well-being .",
"as such , the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis .",
"clinicaltrials.gov identifier : nct@ ."
] | poor sleep is prevalent in patients with systemic inflammatory disorders , including rheumatoid arthritis , and , in addition to fatigue , pain , depression and inflammation , is associated with an increased risk of co-morbidity and all-cause mortality . whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue , no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis . the aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep , assessed both objectively and subjectively in patients with rheumatoid arthritis . a randomized controlled trial including @ patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group . the intervention consists of @ session intermittent aerobic exercise training on a bicycle ergometer three times a week . patients are evaluated according to objective changes in sleep as measured by polysomnography ( primary outcome ) . secondary outcomes include changes in subjective sleep quality and sleep disturbances , fatigue , pain , depressive symptoms , physical function , health-related quality of life and cardiorespiratory fitness . this trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis , which is considered important in promotion of health and well-being . as such , the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis . clinicaltrials.gov identifier : nct@ . | 24,559,487 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"syncope is a cause of significant morbidity in sick sinus syndrome ( sss ) which may not be resolved with permanent pacemaker therapy .",
"we aimed to determine the incidence , predictors and prognostic implication of syncope in paced patients with sss .",
"we studied @ patients ( mean age @ years , sd @ ) with sss who were randomised in the danpace study to either rate-responsive single chamber pacing ( n = @ ) or rate-responsive dual chamber pacing ( n = @ ) .",
"main outcome measures were patient-reported syncope after pacemaker implantation and mortality .",
"mean follow-up was @ years ( sd @ ) .",
"a total of @ ( @ % ) patients experienced syncope after pacemaker implantation ( @ ( @ % ) from the rate-responsive single chamber pacing group , and @ ( @ % ) from the rate-responsive dual chamber pacing group .",
"predictors of syncope post pacemaker implantation included : age @-@ years ( hr @ , @ % ci @ to @ , p = @ ; reference range @-@ years ) , age @ years ( hr @ , @ % ci @ to @ , p = @ ) , syncope prior to pacemaker implant ( hr @ , @ % ci @ to @ , p < @ ) , previous myocardial infarction ( hr @ , @ % ci @ to @ , p = @ ) , heart failure ( hr @ , @ % ci @ to @ , p = @ ) , and high charlson comorbidity index ( hr @ , @ % ci @ to @ , p = @ ) .",
"patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not ( adjusted hr @ , @ % ci @ to @ , p < @ ) .",
"syncope in paced patients with sss is common , and is associated with higher mortality .",
"the predictors identified in this study suggest a multifactorial aetiology of syncope ."
] | syncope is a cause of significant morbidity in sick sinus syndrome ( sss ) which may not be resolved with permanent pacemaker therapy . we aimed to determine the incidence , predictors and prognostic implication of syncope in paced patients with sss . we studied @ patients ( mean age @ years , sd @ ) with sss who were randomised in the danpace study to either rate-responsive single chamber pacing ( n = @ ) or rate-responsive dual chamber pacing ( n = @ ) . main outcome measures were patient-reported syncope after pacemaker implantation and mortality . mean follow-up was @ years ( sd @ ) . a total of @ ( @ % ) patients experienced syncope after pacemaker implantation ( @ ( @ % ) from the rate-responsive single chamber pacing group , and @ ( @ % ) from the rate-responsive dual chamber pacing group . predictors of syncope post pacemaker implantation included : age @-@ years ( hr @ , @ % ci @ to @ , p = @ ; reference range @-@ years ) , age @ years ( hr @ , @ % ci @ to @ , p = @ ) , syncope prior to pacemaker implant ( hr @ , @ % ci @ to @ , p < @ ) , previous myocardial infarction ( hr @ , @ % ci @ to @ , p = @ ) , heart failure ( hr @ , @ % ci @ to @ , p = @ ) , and high charlson comorbidity index ( hr @ , @ % ci @ to @ , p = @ ) . patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not ( adjusted hr @ , @ % ci @ to @ , p < @ ) . syncope in paced patients with sss is common , and is associated with higher mortality . the predictors identified in this study suggest a multifactorial aetiology of syncope . | 24,711,481 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"surgery remains the dominant treatment for large-bowel obstruction , with emerging data on self-expanding metallic stents .",
"the aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression .",
"this study reports on a randomized control trial ( registry number actrn@ ) .",
"this study was conducted at royal prince alfred hospital , sydney , and western hospital , melbourne .",
"patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion .",
"the primary end point was differences in euroqol eq-@d quality of life .",
"secondary end points included overall survival , @-day mortality , stoma rates , postoperative recovery , complications , and readmissions .",
"fifty-two patients of @ needed to reach the calculated sample size were evaluated .",
"stent insertion was successful in @ of @ ( @ % ) patients .",
"the remaining @ patients required a stoma compared with @ of @ ( @ % ) surgery group patients ( p < @ ) .",
"there were no stent-related perforations or deaths .",
"the surgery group had significantly reduced quality of life compared with the stent group from baseline to @ and @ weeks ( p = @ and p = @ ) , and from baseline to @ months ( p = @ ) in favor of the stent group , whereas both reported reduced quality of life .",
"the stent group had an @ % @-day mortality compared with @ % for the surgery group ( p = @ ) .",
"median survival was @ and @ months for the groups ( p = @ ) .",
"the stent group had significantly reduced procedure time ( p = @ ) , postprocedure stay ( p = @ ) , days nothing by mouth ( p = @ ) , and days before free access to solids ( p = @ ) .",
"this study was limited by the lack of an eq-@d australian-based population set .",
"stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet , decreased stoma rates , reduced postprocedure stay , and some quality-of-life benefits ."
] | surgery remains the dominant treatment for large-bowel obstruction , with emerging data on self-expanding metallic stents . the aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression . this study reports on a randomized control trial ( registry number actrn@ ) . this study was conducted at royal prince alfred hospital , sydney , and western hospital , melbourne . patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion . the primary end point was differences in euroqol eq-@d quality of life . secondary end points included overall survival , @-day mortality , stoma rates , postoperative recovery , complications , and readmissions . fifty-two patients of @ needed to reach the calculated sample size were evaluated . stent insertion was successful in @ of @ ( @ % ) patients . the remaining @ patients required a stoma compared with @ of @ ( @ % ) surgery group patients ( p < @ ) . there were no stent-related perforations or deaths . the surgery group had significantly reduced quality of life compared with the stent group from baseline to @ and @ weeks ( p = @ and p = @ ) , and from baseline to @ months ( p = @ ) in favor of the stent group , whereas both reported reduced quality of life . the stent group had an @ % @-day mortality compared with @ % for the surgery group ( p = @ ) . median survival was @ and @ months for the groups ( p = @ ) . the stent group had significantly reduced procedure time ( p = @ ) , postprocedure stay ( p = @ ) , days nothing by mouth ( p = @ ) , and days before free access to solids ( p = @ ) . this study was limited by the lack of an eq-@d australian-based population set . stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet , decreased stoma rates , reduced postprocedure stay , and some quality-of-life benefits . | 26,252,845 | [
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to identify risk factors for headache and migraine in children with sickle cell disease and test the hypothesis that either or both are independently associated with silent cerebral infarcts .",
"in this cross-sectional study , we evaluated the health history , laboratory values , and brain magnetic resonance imaging findings of participants with sickle cell disease ( hemoglobinss or hemoglobins-thalassemia ) with no history of overt stroke or seizures .",
"participants characterized headache severity and quality .",
"migraine was defined by international headache society criteria modified for increased sensitivity in children .",
"neuroradiology and neurology committees adjudicated the presence of silent cerebral infarction by review of magnetic resonance imaging and standardized examination by pediatric neurologists .",
"the cohort included @ children ( @ % males ) , ranging in age from @ to @ years ( mean age , @ years ) .",
"of these children , @ ( @ % ) reported recurrent headaches , and @ ( @ % ) reported migraines .",
"in multivariable logistic regression analyses , both were associated with lower steady-state hemoglobin ( p = @ for headaches ; p < @ for migraines ) and higher pain rate ( p < @ for headaches ; p < @ for migraines ) , defined as the number of admissions requiring opioids in the previous @ years .",
"the presence of silent cerebral infarction was not associated with recurrent headaches or migraines .",
"only @ % ( @ of @ ) of children with recurrent headaches received medication for headache prophylaxis .",
"recurrent headaches and migraines are common and undertreated in children with sickle cell disease .",
"low hemoglobin levels and high pain rates are associated with recurrent headaches and migraines ; whereas , silent cerebral infarction is not ."
] | to identify risk factors for headache and migraine in children with sickle cell disease and test the hypothesis that either or both are independently associated with silent cerebral infarcts . in this cross-sectional study , we evaluated the health history , laboratory values , and brain magnetic resonance imaging findings of participants with sickle cell disease ( hemoglobinss or hemoglobins-thalassemia ) with no history of overt stroke or seizures . participants characterized headache severity and quality . migraine was defined by international headache society criteria modified for increased sensitivity in children . neuroradiology and neurology committees adjudicated the presence of silent cerebral infarction by review of magnetic resonance imaging and standardized examination by pediatric neurologists . the cohort included @ children ( @ % males ) , ranging in age from @ to @ years ( mean age , @ years ) . of these children , @ ( @ % ) reported recurrent headaches , and @ ( @ % ) reported migraines . in multivariable logistic regression analyses , both were associated with lower steady-state hemoglobin ( p = @ for headaches ; p < @ for migraines ) and higher pain rate ( p < @ for headaches ; p < @ for migraines ) , defined as the number of admissions requiring opioids in the previous @ years . the presence of silent cerebral infarction was not associated with recurrent headaches or migraines . only @ % ( @ of @ ) of children with recurrent headaches received medication for headache prophylaxis . recurrent headaches and migraines are common and undertreated in children with sickle cell disease . low hemoglobin levels and high pain rates are associated with recurrent headaches and migraines ; whereas , silent cerebral infarction is not . | 24,529,619 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease .",
"its effect in patients using fixed combinations of inhaled corticosteroids and longacting @ agonists is unknown .",
"we postulated that roflumilast would reduce exacerbations in patients with severe chronic obstructive pulmonary disease at risk for exacerbations , even in combination with inhaled corticosteroid and longacting @ agonist treatment .",
"for this @-year double-blind , placebo-controlled , parallel group , multicentre , phase @-@ trial , the roflumilast and exacerbations in patients receiving appropriate combination therapy ( react ) study , we enrolled patients with severe chronic obstructive pulmonary disease from @ centres ( outpatient clinics , hospitals , specialised pulmonologists , and family doctors ) in @ countries .",
"eligible patients were @ years of age or older with a smoking history of at least @ pack-years and a diagnosis of chronic obstructive pulmonary disease with severe airflow limitation , symptoms of chronic bronchitis , and at least two exacerbations in the previous year .",
"we used a computerised central randomisation system to randomly assign patients in a @:@ ratio to the two treatment groups : roflumilast @ g or placebo given orally once daily together with a fixed inhaled corticosteroid and longacting @ agonist combination .",
"background tiotropium treatment was allowed .",
"all patients and investigators were masked to group assignment .",
"the primary outcome was the rate of moderate to severe chronic obstructive pulmonary disease exacerbations per patient per year , analysed by intention to treat .",
"this study is registered with clinicaltrials.gov , number nct@ .",
"between april @ , @ , and may @ , @ , we enrolled @ eligible participants and randomly assigned @ to the roflumilast group and @ to the placebo group .",
"the rate of moderate-to-severe chronic obstructive pulmonary disease exacerbations was @ % lower in the roflumilast group than in the placebo group according to a poisson regression analysis ( roflumilast @ vs placebo @ ; rate ratio -lsb- rr -rsb- @ -lsb- @ % ci @-@ -rsb- , p = @ ) , and @ % lower according to a predefined sensitivity analysis using negative binomial regression ( @ vs @ ; @ -lsb- @-@ -rsb- , p = @ ) .",
"adverse events were reported by @ ( @ % ) of @ patients receiving roflumilast and by @ ( @ % ) of @ patients in the placebo group ; adverse event-associated patient withdrawal from the study was also more common in the roflumilast group ( @/@ -lsb- @ % -rsb- ) than in the placebo group ( @/@ -lsb- @ % -rsb- ) .",
"the most frequently reported serious adverse events were chronic obstructive pulmonary disease exacerbations and pneumonia , and @ ( @ % ) deaths occurred in the roflumilast group compared with @ ( @ % ) in the placebo group .",
"our findings suggest that roflumilast reduces exacerbations and hospital admissions in patients with severe chronic obstructive pulmonary disease and chronic bronchitis who are at risk of frequent and severe exacerbations despite inhaled corticosteroid and longacting @ agonist therapy , even in combination with tiotropium .",
"takeda ."
] | roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease . its effect in patients using fixed combinations of inhaled corticosteroids and longacting @ agonists is unknown . we postulated that roflumilast would reduce exacerbations in patients with severe chronic obstructive pulmonary disease at risk for exacerbations , even in combination with inhaled corticosteroid and longacting @ agonist treatment . for this @-year double-blind , placebo-controlled , parallel group , multicentre , phase @-@ trial , the roflumilast and exacerbations in patients receiving appropriate combination therapy ( react ) study , we enrolled patients with severe chronic obstructive pulmonary disease from @ centres ( outpatient clinics , hospitals , specialised pulmonologists , and family doctors ) in @ countries . eligible patients were @ years of age or older with a smoking history of at least @ pack-years and a diagnosis of chronic obstructive pulmonary disease with severe airflow limitation , symptoms of chronic bronchitis , and at least two exacerbations in the previous year . we used a computerised central randomisation system to randomly assign patients in a @:@ ratio to the two treatment groups : roflumilast @ g or placebo given orally once daily together with a fixed inhaled corticosteroid and longacting @ agonist combination . background tiotropium treatment was allowed . all patients and investigators were masked to group assignment . the primary outcome was the rate of moderate to severe chronic obstructive pulmonary disease exacerbations per patient per year , analysed by intention to treat . this study is registered with clinicaltrials.gov , number nct@ . between april @ , @ , and may @ , @ , we enrolled @ eligible participants and randomly assigned @ to the roflumilast group and @ to the placebo group . the rate of moderate-to-severe chronic obstructive pulmonary disease exacerbations was @ % lower in the roflumilast group than in the placebo group according to a poisson regression analysis ( roflumilast @ vs placebo @ ; rate ratio -lsb- rr -rsb- @ -lsb- @ % ci @-@ -rsb- , p = @ ) , and @ % lower according to a predefined sensitivity analysis using negative binomial regression ( @ vs @ ; @ -lsb- @-@ -rsb- , p = @ ) . adverse events were reported by @ ( @ % ) of @ patients receiving roflumilast and by @ ( @ % ) of @ patients in the placebo group ; adverse event-associated patient withdrawal from the study was also more common in the roflumilast group ( @/@ -lsb- @ % -rsb- ) than in the placebo group ( @/@ -lsb- @ % -rsb- ) . the most frequently reported serious adverse events were chronic obstructive pulmonary disease exacerbations and pneumonia , and @ ( @ % ) deaths occurred in the roflumilast group compared with @ ( @ % ) in the placebo group . our findings suggest that roflumilast reduces exacerbations and hospital admissions in patients with severe chronic obstructive pulmonary disease and chronic bronchitis who are at risk of frequent and severe exacerbations despite inhaled corticosteroid and longacting @ agonist therapy , even in combination with tiotropium . takeda . | 25,684,586 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"to test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait .",
"single-blinded randomized clinical trial .",
"university research laboratory .",
"adults ( n = @ ) aged @ years with gait speed > @ m/s and impaired motor skill ( figure-of-@ walk time > @s ) .",
"the @ interventions included a task-oriented motor learning and a standard exercise program ; both interventions included strength training .",
"both lasted @ weeks , with twice-weekly , @-hour , physical therapist-supervised sessions .",
"two measures of the motor control of gait , gait variability and smoothness of walking , were assessed pre - and postintervention by assessors masked to the treatment arm .",
"of @ randomized subjects , @ completed the trial ( mean age sd , @ y ) .",
"the motor learning group improved more than the standard group in double-support time variability ( @ m/s vs @ m/s ; adjusted difference -lsb- ad -rsb- = @ , p = @ ) .",
"smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions ( usual : ad = @ , p = @ ; narrow : ad = @ , p = @ ; dual task : ad = @ , p = @ ) .",
"smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path ( ad = @ , p = @ ) and dual-task ( ad = @ , p = @ ) conditions .",
"among older adults with subclinical walking difficulty , there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking , while standard exercise does not .",
"task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults , and needs to be evaluated in a definitive larger trial ."
] | to test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait . single-blinded randomized clinical trial . university research laboratory . adults ( n = @ ) aged @ years with gait speed > @ m/s and impaired motor skill ( figure-of-@ walk time > @s ) . the @ interventions included a task-oriented motor learning and a standard exercise program ; both interventions included strength training . both lasted @ weeks , with twice-weekly , @-hour , physical therapist-supervised sessions . two measures of the motor control of gait , gait variability and smoothness of walking , were assessed pre - and postintervention by assessors masked to the treatment arm . of @ randomized subjects , @ completed the trial ( mean age sd , @ y ) . the motor learning group improved more than the standard group in double-support time variability ( @ m/s vs @ m/s ; adjusted difference -lsb- ad -rsb- = @ , p = @ ) . smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions ( usual : ad = @ , p = @ ; narrow : ad = @ , p = @ ; dual task : ad = @ , p = @ ) . smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path ( ad = @ , p = @ ) and dual-task ( ad = @ , p = @ ) conditions . among older adults with subclinical walking difficulty , there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking , while standard exercise does not . task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults , and needs to be evaluated in a definitive larger trial . | 25,448,244 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"in an attempt to investigate new strategies aimed at reducing inflammation in osteoarthritis , the anti-inflammatory effect of elaeagnus angustifolia l. as a complementary treatment was evaluated in females with knee osteoarthritis .",
"in this clinical trial , @ females with mild to moderate osteoarthritis were assigned to two intervention and one placebo groups .",
"in addition to the conventional therapy , the patients in intervention groups received @g/day of e. angustifolia l. medulla and whole fruit powders respectively for @ weeks .",
"the levels of tumor necrosis factor-alpha ( tnf - ) , interleukine-@ ( il-@ ) , interleukine-@ ( il-@ ) , matrix metalloproteinase-@ ( mmp-@ ) and -@ ( mmp-@ ) were measured with human elisa kits .",
"paired t-test and anova were used for statistical analysis .",
"the statistically significant decrease was observed in the mean levels of serum tnf - in the medulla ( @ ) and whole fruit ( @ ) groups after @ weeks of supplementation .",
"in contrast to the placebo group , there was a significant rise in the mean levels of serum il-@ in medulla ( p-value = @ ) and whole fruit groups ( p-value = @ ) at the end of study .",
"the interventions resulted in significant decrease in the mean levels of serum mmp-@ in the medulla ( @ ) and whole fruit ( @ ) groups .",
"after the interventions , no significant changes were observed in the serum il-@ and mmp-@ levels .",
"daily supplementation with e. angustifolia l. in both forms of medulla and whole fruit powders appeared to be effective for decreasing inflammatory cytokines ( tnf - and mmp-@ ) and enhancing anti-inflammatory cytokines ( il-@ ) ."
] | in an attempt to investigate new strategies aimed at reducing inflammation in osteoarthritis , the anti-inflammatory effect of elaeagnus angustifolia l. as a complementary treatment was evaluated in females with knee osteoarthritis . in this clinical trial , @ females with mild to moderate osteoarthritis were assigned to two intervention and one placebo groups . in addition to the conventional therapy , the patients in intervention groups received @g/day of e. angustifolia l. medulla and whole fruit powders respectively for @ weeks . the levels of tumor necrosis factor-alpha ( tnf - ) , interleukine-@ ( il-@ ) , interleukine-@ ( il-@ ) , matrix metalloproteinase-@ ( mmp-@ ) and -@ ( mmp-@ ) were measured with human elisa kits . paired t-test and anova were used for statistical analysis . the statistically significant decrease was observed in the mean levels of serum tnf - in the medulla ( @ ) and whole fruit ( @ ) groups after @ weeks of supplementation . in contrast to the placebo group , there was a significant rise in the mean levels of serum il-@ in medulla ( p-value = @ ) and whole fruit groups ( p-value = @ ) at the end of study . the interventions resulted in significant decrease in the mean levels of serum mmp-@ in the medulla ( @ ) and whole fruit ( @ ) groups . after the interventions , no significant changes were observed in the serum il-@ and mmp-@ levels . daily supplementation with e. angustifolia l. in both forms of medulla and whole fruit powders appeared to be effective for decreasing inflammatory cytokines ( tnf - and mmp-@ ) and enhancing anti-inflammatory cytokines ( il-@ ) . | 25,440,377 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"we investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type @ diabetes .",
"we studied @ adults ( @ men , @ women , mean age @ @ ) who had been recruited to the early activity in diabetes ( early actid ) randomised controlled trial .",
"c-reactive protein ( crp ) , adiponectin , soluble intracellular adhesion molecule-@ ( sicam-@ ) , interleukin-@ ( il-@ ) , and accelerometer-determined sedentary time and moderate-vigorous physical activity ( mvpa ) were measured at baseline and after six-months .",
"linear regression analysis was used to investigate the independent cross-sectional and longitudinal associations of sedentary time with markers of inflammation .",
"at baseline , associations between sedentary time and il-@ were observed in men and women , an association that was attenuated following adjustment for waist circumference .",
"after @ months of follow-up , sedentary time was reduced by @ @ h per day in women , with the change in sedentary time predicting crp at follow-up .",
"every hour decrease in sedentary time between baseline and six-months was associated with @ % ( @ , @ ) lower crp .",
"no changes in sedentary time between baseline and @ months were seen in men .",
"higher sedentary time is associated with il-@ in men and women with type @ diabetes , and reducing sedentary time is associated with improved levels of crp in women .",
"interventions to reduce sedentary time may help to reduce inflammation in women with type @ diabetes ."
] | we investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type @ diabetes . we studied @ adults ( @ men , @ women , mean age @ @ ) who had been recruited to the early activity in diabetes ( early actid ) randomised controlled trial . c-reactive protein ( crp ) , adiponectin , soluble intracellular adhesion molecule-@ ( sicam-@ ) , interleukin-@ ( il-@ ) , and accelerometer-determined sedentary time and moderate-vigorous physical activity ( mvpa ) were measured at baseline and after six-months . linear regression analysis was used to investigate the independent cross-sectional and longitudinal associations of sedentary time with markers of inflammation . at baseline , associations between sedentary time and il-@ were observed in men and women , an association that was attenuated following adjustment for waist circumference . after @ months of follow-up , sedentary time was reduced by @ @ h per day in women , with the change in sedentary time predicting crp at follow-up . every hour decrease in sedentary time between baseline and six-months was associated with @ % ( @ , @ ) lower crp . no changes in sedentary time between baseline and @ months were seen in men . higher sedentary time is associated with il-@ in men and women with type @ diabetes , and reducing sedentary time is associated with improved levels of crp in women . interventions to reduce sedentary time may help to reduce inflammation in women with type @ diabetes . | 24,925,122 | [
"OBJECTIVE",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to investigate the lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome ( acs ) patients complicating with dyslipedemia .",
"one hundred and four hospitalized patients with established acs and increased serum triglycerides ( tg ) levels and/or low serum levels of high density lipoprotein cholesterol ( hdl-c ) were selected .",
"except for conventional therapy , the patients were randomly divided into @ groups : control group ( n = @ ) , treated with atorvastatin @ mg qn or other statin equivalent to @ mg atorvastatin ; treatment group ( n = @ ) , treated with the same dose statin plus bezafibrate @ mg bid .",
"the serum levels of total cholesterol ( tc ) , tg , low-density lipoprotein cholesterol ( ldl-c ) and hdl-c were assessed before and after @ and @ weeks treatment , side effects and adverse events were recorded .",
"after @ weeks treatment , the serum levels of tc , tg and ldl-c in two groups were significantly reduced compared to baseline ( all p < @ ) , which were further declined after @ weeks treatment , and the reduction was more significant in treatment group ( @ % , @ % and @ % , respectively ) than in control group ( @ % , @ % and @ % , respectively ) ( all p < @ ) .",
"after treatment , the serum levels of hdl-c in the two groups were significantly higher than the baseline levels , especially after @ weeks treatment ( all p < @ ) , and the elevations of hdl-c levels in control group and in treatment group were @ % and @ % , respectively , but there were no significant difference between the two groups ( p > @ ) .",
"after @ weeks , the rates reaching to target goals of ldl-c , tg , hdl-c , and non-hdl-c levels in the treatment group ( @ % , @ % , @ % , @ % and @ % , respectively ) were significantly higher than those in the control group ( @ % , @ % , @ % , @ % and @ % , respectively , all p < @ ) .",
"no serious side effects were observed in the two groups during the treatment period .",
"the combined statin and bezafibrate treatment is safe and could increase the ratios of reaching target lipid levels in acs patients complicating with increased tg and ( or ) decreased hdl-c ."
] | to investigate the lipid-regulating effect and safety of combined statin and bezafibrate therapy in acute coronary syndrome ( acs ) patients complicating with dyslipedemia . one hundred and four hospitalized patients with established acs and increased serum triglycerides ( tg ) levels and/or low serum levels of high density lipoprotein cholesterol ( hdl-c ) were selected . except for conventional therapy , the patients were randomly divided into @ groups : control group ( n = @ ) , treated with atorvastatin @ mg qn or other statin equivalent to @ mg atorvastatin ; treatment group ( n = @ ) , treated with the same dose statin plus bezafibrate @ mg bid . the serum levels of total cholesterol ( tc ) , tg , low-density lipoprotein cholesterol ( ldl-c ) and hdl-c were assessed before and after @ and @ weeks treatment , side effects and adverse events were recorded . after @ weeks treatment , the serum levels of tc , tg and ldl-c in two groups were significantly reduced compared to baseline ( all p < @ ) , which were further declined after @ weeks treatment , and the reduction was more significant in treatment group ( @ % , @ % and @ % , respectively ) than in control group ( @ % , @ % and @ % , respectively ) ( all p < @ ) . after treatment , the serum levels of hdl-c in the two groups were significantly higher than the baseline levels , especially after @ weeks treatment ( all p < @ ) , and the elevations of hdl-c levels in control group and in treatment group were @ % and @ % , respectively , but there were no significant difference between the two groups ( p > @ ) . after @ weeks , the rates reaching to target goals of ldl-c , tg , hdl-c , and non-hdl-c levels in the treatment group ( @ % , @ % , @ % , @ % and @ % , respectively ) were significantly higher than those in the control group ( @ % , @ % , @ % , @ % and @ % , respectively , all p < @ ) . no serious side effects were observed in the two groups during the treatment period . the combined statin and bezafibrate treatment is safe and could increase the ratios of reaching target lipid levels in acs patients complicating with increased tg and ( or ) decreased hdl-c . | 24,524,601 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"low-fluence q-switched neodymium-doped yttrium-aluminum-garnet @,@-nm laser ( lfqs ) and glycolic acid ( ga ) peeling have been reported as a treatment option for melasma .",
"however , there are limited data on their efficacy in men .",
"to compare the efficacy and safety of lfqs monotherapy with combined lfqs and @ % ga peeling in male patients with melasma .",
"fifteen males with mixed type melasma were randomized to receive @ weekly sessions of lfqs on one side of the face and lfqs plus @ % ga peeling on the contralateral side and were followed for @ weeks .",
"twelve patients completed the protocol .",
"mean relative lightness index ( rl * i ) of the combined treatment side was lowered throughout the study period , with the maximal improvement of @ % reduction at the fourth week follow-up ( p = @ ) .",
"patient self-assessment was favorable in the combined treatment .",
"however , the mean rl * i increased at @ and @ weeks of follow-up .",
"one subject ( @ % ) developed guttate hypopigmentation , which did not resolve by the @-week follow-up .",
"low-fluence q-switched neodymium-doped yttrium-aluminum-garnet @,@-nm laser combined with ga peeling temporarily reduced melasma in men , but the incidence of side effects does not justify the short-lived benefits of this procedure .",
"this technique requires further study ."
] | low-fluence q-switched neodymium-doped yttrium-aluminum-garnet @,@-nm laser ( lfqs ) and glycolic acid ( ga ) peeling have been reported as a treatment option for melasma . however , there are limited data on their efficacy in men . to compare the efficacy and safety of lfqs monotherapy with combined lfqs and @ % ga peeling in male patients with melasma . fifteen males with mixed type melasma were randomized to receive @ weekly sessions of lfqs on one side of the face and lfqs plus @ % ga peeling on the contralateral side and were followed for @ weeks . twelve patients completed the protocol . mean relative lightness index ( rl * i ) of the combined treatment side was lowered throughout the study period , with the maximal improvement of @ % reduction at the fourth week follow-up ( p = @ ) . patient self-assessment was favorable in the combined treatment . however , the mean rl * i increased at @ and @ weeks of follow-up . one subject ( @ % ) developed guttate hypopigmentation , which did not resolve by the @-week follow-up . low-fluence q-switched neodymium-doped yttrium-aluminum-garnet @,@-nm laser combined with ga peeling temporarily reduced melasma in men , but the incidence of side effects does not justify the short-lived benefits of this procedure . this technique requires further study . | 25,760,554 | [
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"while physical exercise as adjunctive treatment for major depression has received considerable attention in recent years , the evidence is conflicting .",
"this study evaluates the effects of two different add-on treatments : exercise and basic body awareness therapy .",
"randomized controlled trial with two intervention groups and one control , including @ adults on antidepressant medication , who fulfilled criteria for current major depression as determined by the mini international neuropsychiatric interview .",
"interventions ( @ weeks ) were aerobic exercise or basic body awareness therapy ( bbat ) , compared to a single consultation with advice on physical activity .",
"primary outcome was depression severity , rated by a blinded assessor using the montgomery asberg rating scale ( madrs ) .",
"secondary outcomes were global function , cardiovascular fitness , self-rated depression , anxiety and body awareness .",
"improvements in madrs score ( mean change = -@ , @ % ci ( -@ to -@ ) , p = @ ) and cardiovascular fitness ( mean change = @ ml oxygen/kg/min , @ % ci ( @ to @ ) , p = @ ) were observed in the exercise group .",
"per-protocol analysis confirmed the effects of exercise , and indicated that bbat has an effect on self-rated depression .",
"the small sample size and the challenge of missing data .",
"participants positive expectations regarding the exercise intervention need to be considered .",
"exercise in a physical therapy setting seems to have effect on depression severity and fitness , in major depression .",
"our findings suggest that physical therapy can be a viable clinical strategy to inspire and guide persons with major depression to exercise .",
"more research is needed to clarify the effects of basic body awareness therapy ."
] | while physical exercise as adjunctive treatment for major depression has received considerable attention in recent years , the evidence is conflicting . this study evaluates the effects of two different add-on treatments : exercise and basic body awareness therapy . randomized controlled trial with two intervention groups and one control , including @ adults on antidepressant medication , who fulfilled criteria for current major depression as determined by the mini international neuropsychiatric interview . interventions ( @ weeks ) were aerobic exercise or basic body awareness therapy ( bbat ) , compared to a single consultation with advice on physical activity . primary outcome was depression severity , rated by a blinded assessor using the montgomery asberg rating scale ( madrs ) . secondary outcomes were global function , cardiovascular fitness , self-rated depression , anxiety and body awareness . improvements in madrs score ( mean change = -@ , @ % ci ( -@ to -@ ) , p = @ ) and cardiovascular fitness ( mean change = @ ml oxygen/kg/min , @ % ci ( @ to @ ) , p = @ ) were observed in the exercise group . per-protocol analysis confirmed the effects of exercise , and indicated that bbat has an effect on self-rated depression . the small sample size and the challenge of missing data . participants positive expectations regarding the exercise intervention need to be considered . exercise in a physical therapy setting seems to have effect on depression severity and fitness , in major depression . our findings suggest that physical therapy can be a viable clinical strategy to inspire and guide persons with major depression to exercise . more research is needed to clarify the effects of basic body awareness therapy . | 25,043,321 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"interest in online positive psychology interventions ( oppis ) continues to grow .",
"the empirical literature has identified design factors ( e.g. , variety and duration of activities ) and moderators ( e.g. , personality traits ) that can influence their effectiveness .",
"a randomized controlled trial tested an empirically informed oppi designed to promote self-efficacy and an optimistic outlook .",
"pessimism was included as a trait moderator .",
"participants ( n = @ ) were english-speaking adults interested in becoming happier .",
"they were randomly assigned to complete either an oppi cultivating optimism or a control condition writing about daily activities for @ weeks .",
"follow-up assessments occurred @ and @ months following the exercise period .",
"a hierarchical linear model analysis indicated that the optimism intervention increased the pursuit of engagement-related happiness in the short term and reduced dysfunctional attitudes across follow-ups .",
"pessimistic individuals had more to gain and reported fewer depressive symptoms at post-test .",
"these findings support the conclusion that empirically informed online interventions can improve psychological well-being , at least in the short run , and may be particularly helpful when tailored to the needs of the individual ."
] | interest in online positive psychology interventions ( oppis ) continues to grow . the empirical literature has identified design factors ( e.g. , variety and duration of activities ) and moderators ( e.g. , personality traits ) that can influence their effectiveness . a randomized controlled trial tested an empirically informed oppi designed to promote self-efficacy and an optimistic outlook . pessimism was included as a trait moderator . participants ( n = @ ) were english-speaking adults interested in becoming happier . they were randomly assigned to complete either an oppi cultivating optimism or a control condition writing about daily activities for @ weeks . follow-up assessments occurred @ and @ months following the exercise period . a hierarchical linear model analysis indicated that the optimism intervention increased the pursuit of engagement-related happiness in the short term and reduced dysfunctional attitudes across follow-ups . pessimistic individuals had more to gain and reported fewer depressive symptoms at post-test . these findings support the conclusion that empirically informed online interventions can improve psychological well-being , at least in the short run , and may be particularly helpful when tailored to the needs of the individual . | 24,417,602 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"despite their independent cardiovascular disease ( cvd ) advantages , effects of - linolenic acid ( ala ) , monounsaturated fatty acid ( mufa ) , and low-glycemic-load ( gl ) diets have not been assessed in combination .",
"we therefore determined the combined effect of ala , mufa , and low gl on glycemic control and cvd risk factors in type @ diabetes .",
"the study was a parallel design , randomized trial wherein each @-month treatment was conducted in a canadian academic center between march @ and september @ and involved @ participants with type @ diabetes ( hba@c @ % -@ % -lsb- @-@ mmol/mol -rsb- ) treated with oral antihyperglycemic agents .",
"participants were provided with dietary advice on either a low-gl diet with ala and mufa given as a canola oil-enriched bread supplement ( @ g canola oil per @,@ kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) .",
"the primary outcome was hba@c change .",
"secondary outcomes included calculated framingham cvd risk score and reactive hyperemia index ( rhi ) ratio .",
"seventy-nine percent of the test group and @ % of the control group completed the trial .",
"the test diet reduction in hba@c units of -@ % ( -@ mmol/mol ) ( @ % ci -@ % to -@ % -lsb- -@ to -@ mmol/mol -rsb- ) was greater than that for the control diet ( -@ % -lsb- -@ mmol/mol -rsb- -lsb- @ % ci -@ % to -@ % ( -@ to -@ mmol/mol ) -rsb- , p = @ ) , with the greatest benefit observed in those with higher systolic blood pressure ( sbp ) .",
"greater reductions were seen in cvd risk score for the test diet , whereas the rhi ratio increased for the control diet .",
"a canola oil-enriched low-gl diet improved glycemic control in type @ diabetes , particularly in participants with raised sbp , whereas whole grains improved vascular reactivity ."
] | despite their independent cardiovascular disease ( cvd ) advantages , effects of - linolenic acid ( ala ) , monounsaturated fatty acid ( mufa ) , and low-glycemic-load ( gl ) diets have not been assessed in combination . we therefore determined the combined effect of ala , mufa , and low gl on glycemic control and cvd risk factors in type @ diabetes . the study was a parallel design , randomized trial wherein each @-month treatment was conducted in a canadian academic center between march @ and september @ and involved @ participants with type @ diabetes ( hba@c @ % -@ % -lsb- @-@ mmol/mol -rsb- ) treated with oral antihyperglycemic agents . participants were provided with dietary advice on either a low-gl diet with ala and mufa given as a canola oil-enriched bread supplement ( @ g canola oil per @,@ kcal ) ( test ) or a whole-grain diet with a whole-wheat bread supplement ( control ) . the primary outcome was hba@c change . secondary outcomes included calculated framingham cvd risk score and reactive hyperemia index ( rhi ) ratio . seventy-nine percent of the test group and @ % of the control group completed the trial . the test diet reduction in hba@c units of -@ % ( -@ mmol/mol ) ( @ % ci -@ % to -@ % -lsb- -@ to -@ mmol/mol -rsb- ) was greater than that for the control diet ( -@ % -lsb- -@ mmol/mol -rsb- -lsb- @ % ci -@ % to -@ % ( -@ to -@ mmol/mol ) -rsb- , p = @ ) , with the greatest benefit observed in those with higher systolic blood pressure ( sbp ) . greater reductions were seen in cvd risk score for the test diet , whereas the rhi ratio increased for the control diet . a canola oil-enriched low-gl diet improved glycemic control in type @ diabetes , particularly in participants with raised sbp , whereas whole grains improved vascular reactivity . | 24,929,428 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"different types of exercises can help manage chronic neck pain .",
"supervised exercise interventions are widely used , but these protocols require substantial resources .",
"the aim of this trial , which focused on adherence , was to evaluate two home exercise interventions .",
"this parallel group randomized controlled trial included @ women randomly allocated into two groups - a strength training group ( strength , @ subjects ) and a stretching group ( stretch , @ subjects ) .",
"the interventions focused on the neck and shoulder muscles and lasted for @ months .",
"the strength group performed weight training and ended each session with stretching exercises .",
"these stretching exercises constituted the entirety of the stretch group 's training session .",
"both groups were instructed to exercise three times per week .",
"all the participants kept an exercise diary .",
"in addition , all participants were offered support via phone and e-mail .",
"the primary outcomes were pain intensity and function .",
"the trial included a four - to six-month and a twelve-month follow-up .",
"a completer in this study exercised at least @,@ times per week during eight unbroken weeks .",
"a responder in this study reported clinically significant improvements on pain and function .",
"the statistical analyses used the mann whitney u-test , wilcoxon signed-rank test , and x@ test .",
"at four - to six-months , the numbers of completers were @ in the strength group and @ in the stretch group .",
"at twelve months , the corresponding numbers were @ ( strength ) and @ ( stretch ) .",
"at four - to six-months , the proportions of subjects reporting clinically important changes ( strength and stretch ) were for neck pain : @ % and @ % , shoulder pain : @ % and @ % , function : @ % and @ % .",
"at twelve months , the corresponding numbers were for neck pain : @ % and @ % , shoulder pain : @ % and @ % , function : @ % and @ % .",
"no differences in the two primary outcomes between the two interventions were found , a finding that may be due to the insufficient statistical power of the study .",
"both interventions based on home exercises improved the two primary outcomes , but the adherences were relatively low .",
"future studies should investigate ways to improve adherence to home exercise treatments .",
"clinicaltrials.gov id : nct@ ."
] | different types of exercises can help manage chronic neck pain . supervised exercise interventions are widely used , but these protocols require substantial resources . the aim of this trial , which focused on adherence , was to evaluate two home exercise interventions . this parallel group randomized controlled trial included @ women randomly allocated into two groups - a strength training group ( strength , @ subjects ) and a stretching group ( stretch , @ subjects ) . the interventions focused on the neck and shoulder muscles and lasted for @ months . the strength group performed weight training and ended each session with stretching exercises . these stretching exercises constituted the entirety of the stretch group 's training session . both groups were instructed to exercise three times per week . all the participants kept an exercise diary . in addition , all participants were offered support via phone and e-mail . the primary outcomes were pain intensity and function . the trial included a four - to six-month and a twelve-month follow-up . a completer in this study exercised at least @,@ times per week during eight unbroken weeks . a responder in this study reported clinically significant improvements on pain and function . the statistical analyses used the mann whitney u-test , wilcoxon signed-rank test , and x@ test . at four - to six-months , the numbers of completers were @ in the strength group and @ in the stretch group . at twelve months , the corresponding numbers were @ ( strength ) and @ ( stretch ) . at four - to six-months , the proportions of subjects reporting clinically important changes ( strength and stretch ) were for neck pain : @ % and @ % , shoulder pain : @ % and @ % , function : @ % and @ % . at twelve months , the corresponding numbers were for neck pain : @ % and @ % , shoulder pain : @ % and @ % , function : @ % and @ % . no differences in the two primary outcomes between the two interventions were found , a finding that may be due to the insufficient statistical power of the study . both interventions based on home exercises improved the two primary outcomes , but the adherences were relatively low . future studies should investigate ways to improve adherence to home exercise treatments . clinicaltrials.gov id : nct@ . | 24,400,934 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"we conducted a randomised , double blind , placebo controlled trial to assess the efficacy and safety of cilostazol , a selective inhibitor of phosphodiesterase @ , in patients with vasospastic angina ( vsa ) .",
"cilostazol has been shown to induce vascular dilatation , but its efficacy in patients with vsa is unknown .",
"between october @ and july @ , @ patients with confirmed vsa who had @ angina episodes/week despite amlodipine therapy ( @mg/day ) were randomly assigned to receive either cilostazol ( up to @mg/day ) or placebo for @weeks .",
"all patients were given diaries to record the frequency and severity of chest pain ( @-@ grading ) .",
"the primary endpoint was the relative reduction of the weekly incidence of chest pain .",
"baseline characteristics were similar between the two groups .",
"among @ evaluable patients ( @ in the cilostazol group , @ in the placebo group ) , the primary endpoint was significantly greater in the cilostazol group compared with the placebo group ( -@ % vs -@ % , respectively , p = @ ) .",
"the secondary endpoints , including a change in the frequency of chest pain ( -@ vs -@ , respectively , p = @ ) , a change in the chest pain severity scale ( -@ vs -@ , respectively , p = @ ) , and the proportion of chest pain-free patients ( @ % vs @ % , respectively , p = @ ) also significantly favoured cilostazol .",
"headache was the most common adverse event in both groups ( @ % vs @ % , respectively , p = @ ) .",
"cilostazol is an effective therapy for patients with vsa uncontrolled by conventional amlodipine therapy , and has no serious side effects .",
"nct@ ."
] | we conducted a randomised , double blind , placebo controlled trial to assess the efficacy and safety of cilostazol , a selective inhibitor of phosphodiesterase @ , in patients with vasospastic angina ( vsa ) . cilostazol has been shown to induce vascular dilatation , but its efficacy in patients with vsa is unknown . between october @ and july @ , @ patients with confirmed vsa who had @ angina episodes/week despite amlodipine therapy ( @mg/day ) were randomly assigned to receive either cilostazol ( up to @mg/day ) or placebo for @weeks . all patients were given diaries to record the frequency and severity of chest pain ( @-@ grading ) . the primary endpoint was the relative reduction of the weekly incidence of chest pain . baseline characteristics were similar between the two groups . among @ evaluable patients ( @ in the cilostazol group , @ in the placebo group ) , the primary endpoint was significantly greater in the cilostazol group compared with the placebo group ( -@ % vs -@ % , respectively , p = @ ) . the secondary endpoints , including a change in the frequency of chest pain ( -@ vs -@ , respectively , p = @ ) , a change in the chest pain severity scale ( -@ vs -@ , respectively , p = @ ) , and the proportion of chest pain-free patients ( @ % vs @ % , respectively , p = @ ) also significantly favoured cilostazol . headache was the most common adverse event in both groups ( @ % vs @ % , respectively , p = @ ) . cilostazol is an effective therapy for patients with vsa uncontrolled by conventional amlodipine therapy , and has no serious side effects . nct@ . | 24,934,484 | [
"OBJECTIVE",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"to study the clinical effect of development theory based acupuncture on early cerebral palsy ( cp ) infants with parafunctional sitting position .",
"totally @ early cp infants were randomly assigned to two groups equally , the treatment group and the control group .",
"all received acupuncture combined with training rehabilitation .",
"patients in the treatment group adopted acupuncture based on infants development theory , while those in the control group were treated by head acupuncture .",
"sitting functional points in gross motor function measure ( gmfm ) @ were observed in different groups and infant patients of various types before and after treatment .",
"root mean square ( rms ) signals of sitting correlated muscles ( latissimus dorsi , erector spinae , rectus abdominis ) were recorded by surface electromyography ( semg ) .",
"the effective rate was evaluated by nimodipine method .",
"compared with before treatment , sitting functional points were significantly improved in the two groups ( p < @ ) .",
"after treatment , it was higher in the treatment group than in the control group ( p < @ ) .",
"the advance amplitude was higher in cp infants of the spastic type and the hypotonic type than other types ( p < @ ) .",
"along with sitting process , latissimus dorsi rms signals were gradually tapered , erector spinae rms signals were gradually enhanced , and rectus abdominis rms signals were slightly weakened .",
"compared with the control group , latissimus dorsi rms signals obviously decreased , and erector spinae rms signals obviously increased in the treatment group after treatment ( all p < @ ) .",
"the total effective rate was higher in the treatment group than in the control group ( @ % vs. @ % , p < @ ) .",
"infants development theory based acupuncture could effectively elevate dorsi-extensor muscles force , improve sitting position of @ months to @ year old cp infants with parafunctional sitting position ."
] | to study the clinical effect of development theory based acupuncture on early cerebral palsy ( cp ) infants with parafunctional sitting position . totally @ early cp infants were randomly assigned to two groups equally , the treatment group and the control group . all received acupuncture combined with training rehabilitation . patients in the treatment group adopted acupuncture based on infants development theory , while those in the control group were treated by head acupuncture . sitting functional points in gross motor function measure ( gmfm ) @ were observed in different groups and infant patients of various types before and after treatment . root mean square ( rms ) signals of sitting correlated muscles ( latissimus dorsi , erector spinae , rectus abdominis ) were recorded by surface electromyography ( semg ) . the effective rate was evaluated by nimodipine method . compared with before treatment , sitting functional points were significantly improved in the two groups ( p < @ ) . after treatment , it was higher in the treatment group than in the control group ( p < @ ) . the advance amplitude was higher in cp infants of the spastic type and the hypotonic type than other types ( p < @ ) . along with sitting process , latissimus dorsi rms signals were gradually tapered , erector spinae rms signals were gradually enhanced , and rectus abdominis rms signals were slightly weakened . compared with the control group , latissimus dorsi rms signals obviously decreased , and erector spinae rms signals obviously increased in the treatment group after treatment ( all p < @ ) . the total effective rate was higher in the treatment group than in the control group ( @ % vs. @ % , p < @ ) . infants development theory based acupuncture could effectively elevate dorsi-extensor muscles force , improve sitting position of @ months to @ year old cp infants with parafunctional sitting position . | 25,881,458 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"patients who underwent primary inguinal hernia repair still report a high rate of postoperative pain after operation due to the effect of mesh fixation by suture.an alternative is the use of human fibrin glue .",
"we compared the two techniques .",
"@ patients randomly underwent primary inguinal hernia lichtenstein repair fixing the mesh by suture or by human fibrin glue ( hfg ) ; in both cases the mesh was fixed to the posterior wall of the inguinal canal and to the inguinal ligament .",
"no significant differences were recorded between the two groups in terms of complications , while the sutureless technique reduces the operative time and the postoperative pain .",
"a widespread technique for the treatment of inguinal hernia is the application of a mesh using lichtenstein procedure .",
"the prosthesis can be fixed by traditional suture or using a new method of sutureless fixation with adhesive materials that shows an excellent local tolerability and lack of adverse effects and contraindications ."
] | patients who underwent primary inguinal hernia repair still report a high rate of postoperative pain after operation due to the effect of mesh fixation by suture.an alternative is the use of human fibrin glue . we compared the two techniques . @ patients randomly underwent primary inguinal hernia lichtenstein repair fixing the mesh by suture or by human fibrin glue ( hfg ) ; in both cases the mesh was fixed to the posterior wall of the inguinal canal and to the inguinal ligament . no significant differences were recorded between the two groups in terms of complications , while the sutureless technique reduces the operative time and the postoperative pain . a widespread technique for the treatment of inguinal hernia is the application of a mesh using lichtenstein procedure . the prosthesis can be fixed by traditional suture or using a new method of sutureless fixation with adhesive materials that shows an excellent local tolerability and lack of adverse effects and contraindications . | 25,375,054 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"uremic pruritus as a symptom that affects hemodialysis ( hd ) patients can decrease the quality of life and increase morbidity in these patients .",
"the aim of this study was to evaluate the effects of turmeric on uremic pruritus in hd patients .",
"this was a double-blind placebo-controlled trial conducted on @ hd patients suffering from pruritus .",
"patients ( mean age @ @ years ) were randomized into two groups : turmeric and placebo .",
"the pruritus score and biochemical determinants including high-sensitivity c-reactive protein ( hs-crp ) were compared before and at the end of the study between the two groups .",
"the mean decrease in hs-crp was significantly higher in the turmeric than the placebo group ( -@ @ vs. @ @ mg/l , p = @ ) .",
"also reduction of pruritus scores was greater in the turmeric than the placebo group ( @ @ vs. @ @ , p = @ ) .",
"no side effect was observed during the study due to the use of turmeric .",
"this study demonstrates the possible efficacy of turmeric in decreasing hs-crp and uremic pruritus in end stage renal disease patients .",
"future studies are needed to further evaluate the efficacy and safety of turmeric ."
] | uremic pruritus as a symptom that affects hemodialysis ( hd ) patients can decrease the quality of life and increase morbidity in these patients . the aim of this study was to evaluate the effects of turmeric on uremic pruritus in hd patients . this was a double-blind placebo-controlled trial conducted on @ hd patients suffering from pruritus . patients ( mean age @ @ years ) were randomized into two groups : turmeric and placebo . the pruritus score and biochemical determinants including high-sensitivity c-reactive protein ( hs-crp ) were compared before and at the end of the study between the two groups . the mean decrease in hs-crp was significantly higher in the turmeric than the placebo group ( -@ @ vs. @ @ mg/l , p = @ ) . also reduction of pruritus scores was greater in the turmeric than the placebo group ( @ @ vs. @ @ , p = @ ) . no side effect was observed during the study due to the use of turmeric . this study demonstrates the possible efficacy of turmeric in decreasing hs-crp and uremic pruritus in end stage renal disease patients . future studies are needed to further evaluate the efficacy and safety of turmeric . | 24,482,090 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"measurement of mixed venous oxygen saturation helps determine whether cardiac output and oxygen delivery are sufficient for metabolic needs .",
"as recommended by the american association of critical-care nurses guideline , blood samples for determining mixed venous oxygen saturation are obtained by slowly , in @ to @ minutes , withdrawing @ ml of blood from the distal port of the pulmonary artery catheter .",
"in theory , the negative force of rapid withdrawal could pull oxygenated blood from the pulmonary capillary bed , causing falsely elevated saturation values .",
"to determine if the speed of withdrawal affects oxygen content in blood samples used to measure mixed venous oxygen saturation .",
"the sample consisted of heart failure patients with pulmonary artery catheters admitted to a cardiac intensive care unit .",
"a prospective , randomized , @ @ crossover design was used to compare mixed venous oxygen saturation in blood samples obtained quickly or slowly .",
"a total of @ sets of saturation values were analyzed .",
"each set included @ blood sample obtained slowly , in @ to @ minutes , and @ obtained rapidly , in @ seconds .",
"the mean difference in saturation values between the fast and the slow groups was -@ ( ci , -@ to @ ; p = @ ) , indicating that no meaningful systematic bias is attributable to fast withdrawal of blood .",
"rapid blood sampling does not falsely elevate measurements of mixed venous oxygen saturation ."
] | measurement of mixed venous oxygen saturation helps determine whether cardiac output and oxygen delivery are sufficient for metabolic needs . as recommended by the american association of critical-care nurses guideline , blood samples for determining mixed venous oxygen saturation are obtained by slowly , in @ to @ minutes , withdrawing @ ml of blood from the distal port of the pulmonary artery catheter . in theory , the negative force of rapid withdrawal could pull oxygenated blood from the pulmonary capillary bed , causing falsely elevated saturation values . to determine if the speed of withdrawal affects oxygen content in blood samples used to measure mixed venous oxygen saturation . the sample consisted of heart failure patients with pulmonary artery catheters admitted to a cardiac intensive care unit . a prospective , randomized , @ @ crossover design was used to compare mixed venous oxygen saturation in blood samples obtained quickly or slowly . a total of @ sets of saturation values were analyzed . each set included @ blood sample obtained slowly , in @ to @ minutes , and @ obtained rapidly , in @ seconds . the mean difference in saturation values between the fast and the slow groups was -@ ( ci , -@ to @ ; p = @ ) , indicating that no meaningful systematic bias is attributable to fast withdrawal of blood . rapid blood sampling does not falsely elevate measurements of mixed venous oxygen saturation . | 25,362,672 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"CONCLUSIONS"
] |
[
"while many researchers often use a theoretical framework for mammogram repeat interventions , it seems they do not apply an identified mediation analysis method .",
"the aim of this study was to determine the mediators of mammogram replication behavior in two tailored interventions for non-adherent iranian women .",
"a sample population of @ women over @ years old in sanandaj , iran , was selected for an experiment .",
"participants were randomly allocated into one of the three conditions : @ ) an intervention based on the health belief model ( hbm ) @ ) an intervention based on an integration of the hbm and selected constructs from the theory of planned behavior ( tpb ) , and @ ) a control group .",
"constructs were measured before the intervention , and after a @-month follow-up .",
"perceived self-efficacy , behavioral control , and subjective norms were recognized as mediators in the hbm and selected constructs from the tpb intervention .",
"perceived susceptibility , severity , barriers , self-efficacy and behavioral control met the criteria for mediation in the hbm intervention .",
"this study was successful in establishing mediation in a sample of women .",
"our findings enrich the literature on mammography repeat , indicating key intervention factors , and relegating redundant ones in the iranian populations .",
"the use of strategies to increase mammography repeat , such hbm and tpb constructs is suggested to be important for maintaining a screening behavior , once the behavior has been adopted ."
] | while many researchers often use a theoretical framework for mammogram repeat interventions , it seems they do not apply an identified mediation analysis method . the aim of this study was to determine the mediators of mammogram replication behavior in two tailored interventions for non-adherent iranian women . a sample population of @ women over @ years old in sanandaj , iran , was selected for an experiment . participants were randomly allocated into one of the three conditions : @ ) an intervention based on the health belief model ( hbm ) @ ) an intervention based on an integration of the hbm and selected constructs from the theory of planned behavior ( tpb ) , and @ ) a control group . constructs were measured before the intervention , and after a @-month follow-up . perceived self-efficacy , behavioral control , and subjective norms were recognized as mediators in the hbm and selected constructs from the tpb intervention . perceived susceptibility , severity , barriers , self-efficacy and behavioral control met the criteria for mediation in the hbm intervention . this study was successful in establishing mediation in a sample of women . our findings enrich the literature on mammography repeat , indicating key intervention factors , and relegating redundant ones in the iranian populations . the use of strategies to increase mammography repeat , such hbm and tpb constructs is suggested to be important for maintaining a screening behavior , once the behavior has been adopted . | 25,227,834 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"the study examined the efficacy of family-based and adolescent-only hiv prevention programs in decreasing hiv risk and improving parental monitoring and sexual communication among youths in mental health treatment .",
"a randomized controlled trial ( rct ) with @ adolescents ( ages @-@ years ) and their caregivers from mental health settings in three u.s. cities were randomly assigned to one of three theory-based , structured group interventions : family-based hiv prevention , adolescent-only hiv prevention , and adolescent-only health promotion .",
"interventions were delivered during an all-day workshop .",
"assessments were completed at baseline and three months postintervention .",
"compared with those in the health intervention , adolescents in the hiv prevention interventions reported fewer unsafe sex acts ( adjusted rate ratio = @ , p = @ ) , greater condom use ( adjusted relative change = @ % , p = @ ) , and greater likelihood of avoiding sex ( adjusted odds ratio = @ , p = @ ) .",
"they also showed improved hiv knowledge ( p < @ ) and self-efficacy ( p < @ ) .",
"the family-based intervention , compared with the other interventions , produced significant improvements in parent-teen sexual communication ( p < @ ) , parental monitoring ( p < @ ) , and parental permissiveness ( p = @ ) .",
"this rct found that the hiv prevention interventions reduced sexual risk behavior over three months in a large , diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex .",
"these interventions show promise ."
] | the study examined the efficacy of family-based and adolescent-only hiv prevention programs in decreasing hiv risk and improving parental monitoring and sexual communication among youths in mental health treatment . a randomized controlled trial ( rct ) with @ adolescents ( ages @-@ years ) and their caregivers from mental health settings in three u.s. cities were randomly assigned to one of three theory-based , structured group interventions : family-based hiv prevention , adolescent-only hiv prevention , and adolescent-only health promotion . interventions were delivered during an all-day workshop . assessments were completed at baseline and three months postintervention . compared with those in the health intervention , adolescents in the hiv prevention interventions reported fewer unsafe sex acts ( adjusted rate ratio = @ , p = @ ) , greater condom use ( adjusted relative change = @ % , p = @ ) , and greater likelihood of avoiding sex ( adjusted odds ratio = @ , p = @ ) . they also showed improved hiv knowledge ( p < @ ) and self-efficacy ( p < @ ) . the family-based intervention , compared with the other interventions , produced significant improvements in parent-teen sexual communication ( p < @ ) , parental monitoring ( p < @ ) , and parental permissiveness ( p = @ ) . this rct found that the hiv prevention interventions reduced sexual risk behavior over three months in a large , diverse sample of youths in mental health treatment and that the family-based intervention improved parental monitoring and communication with teens about sex . these interventions show promise . | 24,382,603 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"structured educational programmes for patients at risk for anaphylaxis have not yet been established .",
"patients and caregivers often lack adequate skills in managing the disease .",
"to investigate effects of structured patient education intervention on knowledge , emergency management skills and psychological parameters in patients with previous episodes of anaphylaxis and caregivers of affected children @ caregivers ( @ male , @ female , mean age @years ) of affected children and @ patients ( @ male , @ female , mean age @ years ) were randomly assigned to an intervention ( ig ) or control group ( cg ) in a multicentre randomized controlled trial .",
"the ig received two @-h schooling modules of group education ; the cg received standard auto-injector training only .",
"knowledge of anaphylaxis and emergency management competence in a validated training anaphylaxis situation as main outcome measures as well as secondary psychological parameters were assessed at baseline and @months after intervention .",
"in comparison with controls , the intervention led to significant improvement of knowledge from baseline to @-month follow-up ( caregivers : ig @ / @ improvement/baseline vs cg @ / @ ; p < @ ; patients : ig @ / @ vs @ / @ ; p < @ ) .",
"moreover , emergency management competence was increased after intervention as compared to controls ( caregivers : ig @ / @ vs cg @ / @ ; p < @ ; patients : @ / @ vs @ / @ ; p < @ ) .",
"intervention showed significant reduction of caregiver anxiety ( -@ / @ vs -@ / @ ; p < @ ) .",
"there were no significant changes in the depression scores .",
"structured patient education programmes may be beneficial in the management of anaphylaxis by increasing patients ' empowerment to prevent and treat the disease ."
] | structured educational programmes for patients at risk for anaphylaxis have not yet been established . patients and caregivers often lack adequate skills in managing the disease . to investigate effects of structured patient education intervention on knowledge , emergency management skills and psychological parameters in patients with previous episodes of anaphylaxis and caregivers of affected children @ caregivers ( @ male , @ female , mean age @years ) of affected children and @ patients ( @ male , @ female , mean age @ years ) were randomly assigned to an intervention ( ig ) or control group ( cg ) in a multicentre randomized controlled trial . the ig received two @-h schooling modules of group education ; the cg received standard auto-injector training only . knowledge of anaphylaxis and emergency management competence in a validated training anaphylaxis situation as main outcome measures as well as secondary psychological parameters were assessed at baseline and @months after intervention . in comparison with controls , the intervention led to significant improvement of knowledge from baseline to @-month follow-up ( caregivers : ig @ / @ improvement/baseline vs cg @ / @ ; p < @ ; patients : ig @ / @ vs @ / @ ; p < @ ) . moreover , emergency management competence was increased after intervention as compared to controls ( caregivers : ig @ / @ vs cg @ / @ ; p < @ ; patients : @ / @ vs @ / @ ; p < @ ) . intervention showed significant reduction of caregiver anxiety ( -@ / @ vs -@ / @ ; p < @ ) . there were no significant changes in the depression scores . structured patient education programmes may be beneficial in the management of anaphylaxis by increasing patients ' empowerment to prevent and treat the disease . | 25,407,693 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"postoperative atrial fibrillation ( poaf ) is considered to be a transient arrhythmia in the first week after cardiac surgery .",
"to determine the @-day incidence and predictors of poaf and the value of postoperative overdrive biatrial pacing in the prevention of poaf .",
"patients ( n = @ ) without a history of atrial fibrillation undergoing aortic valve replacement or coronary artery bypass graft ( cabg ) were randomized into a pacing group ( n = @ ) and a control group .",
"patients were treated with standardized sotalol postoperatively .",
"rhythm was continuously monitored for @ days by a transtelephonic event recorder .",
"poaf occurred in @ ( @ % ) patients , of whom @ ( @ % ) patients showed poaf during postoperative days ( pods ) @-@ and @ ( @ % ) patients during pods @-@ .",
"prolonged aortic cross-clamp time was an important univariate predictor of @-day and of late poaf ( pods @-@ ; p = @ and p = @ , respectively ) .",
"best-fit model analysis using @ predetermined risk factors for poaf showed different positive interactive effects for early poaf ( ie , baseline c-reactive protein levels with a history of myocardial infarction or low body mass index ) and late poaf ( ie , high body mass index , diabetes mellitus , baseline c-reactive protein , early poaf , creatinine levels , type of operation , smoking , and male gender ) .",
"biatrial pacing reduced the late poaf incidence in patients with aortic cross-clamp time > @ minutes ( p = @ ) .",
"poaf is not limited to the first week after cardiac surgery but also occurs frequently in the postoperative month .",
"it is desirable to regularly follow patients with poaf for atrial fibrillation recurrences after discharge ."
] | postoperative atrial fibrillation ( poaf ) is considered to be a transient arrhythmia in the first week after cardiac surgery . to determine the @-day incidence and predictors of poaf and the value of postoperative overdrive biatrial pacing in the prevention of poaf . patients ( n = @ ) without a history of atrial fibrillation undergoing aortic valve replacement or coronary artery bypass graft ( cabg ) were randomized into a pacing group ( n = @ ) and a control group . patients were treated with standardized sotalol postoperatively . rhythm was continuously monitored for @ days by a transtelephonic event recorder . poaf occurred in @ ( @ % ) patients , of whom @ ( @ % ) patients showed poaf during postoperative days ( pods ) @-@ and @ ( @ % ) patients during pods @-@ . prolonged aortic cross-clamp time was an important univariate predictor of @-day and of late poaf ( pods @-@ ; p = @ and p = @ , respectively ) . best-fit model analysis using @ predetermined risk factors for poaf showed different positive interactive effects for early poaf ( ie , baseline c-reactive protein levels with a history of myocardial infarction or low body mass index ) and late poaf ( ie , high body mass index , diabetes mellitus , baseline c-reactive protein , early poaf , creatinine levels , type of operation , smoking , and male gender ) . biatrial pacing reduced the late poaf incidence in patients with aortic cross-clamp time > @ minutes ( p = @ ) . poaf is not limited to the first week after cardiac surgery but also occurs frequently in the postoperative month . it is desirable to regularly follow patients with poaf for atrial fibrillation recurrences after discharge . | 24,657,803 | [
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"only about a third of patients with an episode of major depressive disorder remit with a given treatment and few remissions occur within the first weeks of treatment .",
"this study tested whether combining escitalopram and bupropion as initial treatment would result in quicker remission and a higher remission rate than monotherapy with either drug .",
"two hundred forty-five outpatients aged @-@ having non-psychotic , non-bipolar major depression were randomly assigned to double-blind treatment with bupropion or escitalopram or the combination dosed to a maximum of bupropion @ mg/d and/or escitalopram @ mg/d for @ weeks .",
"a montgomery-asberg depression rating scale score of @ was required for randomization , while a hamilton rating scale for depression score @ defined remission .",
"we hypothesized that bupropion plus escitalopram would outperform both monotherapies in both earlier onset of remission and higher rate of remission .",
"primary analyses did not demonstrate that dual therapy outperformed both monotherapies in either timing of remission or remission rate .",
"all three treatments were well tolerated .",
"these results do not support initial use of bupropion plus escitalopram to speed or enhance antidepressant response .",
"nct@ ."
] | only about a third of patients with an episode of major depressive disorder remit with a given treatment and few remissions occur within the first weeks of treatment . this study tested whether combining escitalopram and bupropion as initial treatment would result in quicker remission and a higher remission rate than monotherapy with either drug . two hundred forty-five outpatients aged @-@ having non-psychotic , non-bipolar major depression were randomly assigned to double-blind treatment with bupropion or escitalopram or the combination dosed to a maximum of bupropion @ mg/d and/or escitalopram @ mg/d for @ weeks . a montgomery-asberg depression rating scale score of @ was required for randomization , while a hamilton rating scale for depression score @ defined remission . we hypothesized that bupropion plus escitalopram would outperform both monotherapies in both earlier onset of remission and higher rate of remission . primary analyses did not demonstrate that dual therapy outperformed both monotherapies in either timing of remission or remission rate . all three treatments were well tolerated . these results do not support initial use of bupropion plus escitalopram to speed or enhance antidepressant response . nct@ . | 24,485,847 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"atrial fibrillation ( af ) often occurs after coronary artery bypass grafting ( cabg ) and can result in increased morbidity and mortality due to complications .",
"in the present study , our goal was to investigate whether the use of levosimendan can reduce the frequency of af after coronary artery bypass grafting in patients with poor left ventricle function .",
"to investigate the effectiveness of levosimendan in the prophylaxis of af , we conducted a prospective , randomized , placebo-controlled clinical study on @ consecutive patients in whom we performed elective cabg operations .",
"baseline characteristics were similar in both groups .",
"a control group of @ patients were treated with placebo ( @ ml saline solution ) , whereas the levosimendan group ( n = @ patients ) was treated with levosimendan .",
"high-sensitivity c-reactive protein , cardiac troponin , and creatine kinasemb levels were measured before surgery and @ days postoperatively .",
"af occurred in @ % of the levosimendan group and @ % of the control group .",
"the occurrence of af was significantly lower in the levosimendan group ( p < @ ) .",
"the duration of af in the levosimendan group was significantly shorter than that in the control group ( @ @ and @ @ hours , respectively ; p = @ ) .",
"our research showed that c-reactive protein was higher postoperatively in the control group than in the levosimendan group ( p < @ ) .",
"the incidence of postoperative af in the levosimendan group was reduced significantly in patients with poor left ventricle function after cabg operations ."
] | atrial fibrillation ( af ) often occurs after coronary artery bypass grafting ( cabg ) and can result in increased morbidity and mortality due to complications . in the present study , our goal was to investigate whether the use of levosimendan can reduce the frequency of af after coronary artery bypass grafting in patients with poor left ventricle function . to investigate the effectiveness of levosimendan in the prophylaxis of af , we conducted a prospective , randomized , placebo-controlled clinical study on @ consecutive patients in whom we performed elective cabg operations . baseline characteristics were similar in both groups . a control group of @ patients were treated with placebo ( @ ml saline solution ) , whereas the levosimendan group ( n = @ patients ) was treated with levosimendan . high-sensitivity c-reactive protein , cardiac troponin , and creatine kinasemb levels were measured before surgery and @ days postoperatively . af occurred in @ % of the levosimendan group and @ % of the control group . the occurrence of af was significantly lower in the levosimendan group ( p < @ ) . the duration of af in the levosimendan group was significantly shorter than that in the control group ( @ @ and @ @ hours , respectively ; p = @ ) . our research showed that c-reactive protein was higher postoperatively in the control group than in the levosimendan group ( p < @ ) . the incidence of postoperative af in the levosimendan group was reduced significantly in patients with poor left ventricle function after cabg operations . | 24,364,085 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"in lung cancer screening , the prevalence of chronic respiratory symptoms is high among heavy smokers .",
"the purpose of this study was to compare ct-derived airway wall measurements between male smokers with and those without chronic respiratory symptoms .",
"fifty male heavy smokers with chronic respiratory symptoms ( cough , excessive mucus secretion , dyspnea , and wheezing ) and @ without any respiratory symptom were randomly selected from the dutch-belgian randomized lung cancer screening trial .",
"thin-slice low-dose ct images were evaluated with dedicated software for airway measurements .",
"wall area percentage and airway wall thickness were measured from trachea to bronchi in five different pulmonary lobes of airways with a luminal diameter of @ mm or greater .",
"association between airway wall measurements and respiratory symptoms was analyzed by multiple linear regression adjusted for age , body mass index , smoking status , emphysema , and pulmonary function .",
"after adjustment for relevant factors , a significant positive association between airway wall measurements and respiratory symptoms was found in airways with a luminal diameter between @ to @ mm ( p < @ ) , but not in airways measuring @ mm or greater ( p > @ ) .",
"at the airway level between @ to @ mm , the mean wall area percentages were @ % @ % .",
"airway wall thicknesses were @ @ mm and @ @ mm ( p < @ ) .",
"male heavy smokers with chronic respiratory symptoms in lung cancer screening , who are at high-risk of chronic bronchitis , have bronchial wall thickening in airways with a luminal diameter of @-@ mm but not in larger airways ."
] | in lung cancer screening , the prevalence of chronic respiratory symptoms is high among heavy smokers . the purpose of this study was to compare ct-derived airway wall measurements between male smokers with and those without chronic respiratory symptoms . fifty male heavy smokers with chronic respiratory symptoms ( cough , excessive mucus secretion , dyspnea , and wheezing ) and @ without any respiratory symptom were randomly selected from the dutch-belgian randomized lung cancer screening trial . thin-slice low-dose ct images were evaluated with dedicated software for airway measurements . wall area percentage and airway wall thickness were measured from trachea to bronchi in five different pulmonary lobes of airways with a luminal diameter of @ mm or greater . association between airway wall measurements and respiratory symptoms was analyzed by multiple linear regression adjusted for age , body mass index , smoking status , emphysema , and pulmonary function . after adjustment for relevant factors , a significant positive association between airway wall measurements and respiratory symptoms was found in airways with a luminal diameter between @ to @ mm ( p < @ ) , but not in airways measuring @ mm or greater ( p > @ ) . at the airway level between @ to @ mm , the mean wall area percentages were @ % @ % . airway wall thicknesses were @ @ mm and @ @ mm ( p < @ ) . male heavy smokers with chronic respiratory symptoms in lung cancer screening , who are at high-risk of chronic bronchitis , have bronchial wall thickening in airways with a luminal diameter of @-@ mm but not in larger airways . | 25,247,967 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"medical abortion with mifepristone and prostaglandins is well established .",
"we compared clinical assessment with self-assessment of abortion outcome .",
"this randomised , controlled , non-inferiority trial was done in four clinics in austria , finland , norway , and sweden , between aug @ , @ , and jan @ , @ .",
"women aged @ years and older who had requested medical termination of a pregnancy up to @ days of gestation were eligible .",
"computer-generated block randomisation ( block size ten ) assigned women in a @:@ ratio to attend routine clinical follow-up or to self-assess outcome at home with a semiquantitative urine human chorionic gonadotropin ( hcg ) test @-@ weeks after abortion .",
"the primary outcome was the percentage of women with complete abortion not requiring further medical or surgical intervention within @ months .",
"analysis was per protocol and by intention to treat .",
"the non-inferiority margin was five percentage points .",
"this trial is registered with clinicaltrials.gov , number nct@ .",
"@ women were assigned routine follow-up ( n = @ ) or self-assessment ( n = @ ) and included in the intention-to-treat analysis .",
"@ were included in the per-protocol analysis ( n = @ and n = @ , respectively ) .",
"complete abortion was reported in @ ( @ % ) of @ in the routine follow-up group and @ ( @ % ) of @ women in the self-assessment group ( crude difference -@ , @ % ci -@ to @ ) .",
"@ ( @ % ) women in the routine follow-up group and @ ( @ % ) in the self-assessment group required surgery .",
"no women in the routine follow-up group versus three in the self-assessment group had undetected continuing pregnancies .",
"eight ( @ % ) and one ( @ % ) women , respectively , had infections ( p = @ ) .",
"self-assessment was non-inferior to routine follow-up and could save resources .",
"nordic federation of obstetrics and gynaecology , european society of contraception , helsinki university central hospital , helse finnmark , swedish research council , and stockholm county council and karolinska university hospital ."
] | medical abortion with mifepristone and prostaglandins is well established . we compared clinical assessment with self-assessment of abortion outcome . this randomised , controlled , non-inferiority trial was done in four clinics in austria , finland , norway , and sweden , between aug @ , @ , and jan @ , @ . women aged @ years and older who had requested medical termination of a pregnancy up to @ days of gestation were eligible . computer-generated block randomisation ( block size ten ) assigned women in a @:@ ratio to attend routine clinical follow-up or to self-assess outcome at home with a semiquantitative urine human chorionic gonadotropin ( hcg ) test @-@ weeks after abortion . the primary outcome was the percentage of women with complete abortion not requiring further medical or surgical intervention within @ months . analysis was per protocol and by intention to treat . the non-inferiority margin was five percentage points . this trial is registered with clinicaltrials.gov , number nct@ . @ women were assigned routine follow-up ( n = @ ) or self-assessment ( n = @ ) and included in the intention-to-treat analysis . @ were included in the per-protocol analysis ( n = @ and n = @ , respectively ) . complete abortion was reported in @ ( @ % ) of @ in the routine follow-up group and @ ( @ % ) of @ women in the self-assessment group ( crude difference -@ , @ % ci -@ to @ ) . @ ( @ % ) women in the routine follow-up group and @ ( @ % ) in the self-assessment group required surgery . no women in the routine follow-up group versus three in the self-assessment group had undetected continuing pregnancies . eight ( @ % ) and one ( @ % ) women , respectively , had infections ( p = @ ) . self-assessment was non-inferior to routine follow-up and could save resources . nordic federation of obstetrics and gynaecology , european society of contraception , helsinki university central hospital , helse finnmark , swedish research council , and stockholm county council and karolinska university hospital . | 25,468,164 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"a candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than @,@ children between the ages of @ and @ years in asian-pacific and latin american countries .",
"we report the results of long-term follow-up interim analyses and integrated efficacy analyses .",
"we are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years @ to @ of two phase @ trials , cyd@ and cyd@ , and a phase @b trial , cyd@/@ .",
"we estimated vaccine efficacy using pooled data from the first @ months of cyd@ and cyd@ .",
"follow-up data were available for @,@ of @,@ participants ( @ % ) in cyd@ and @,@ of @,@ participants ( @ % ) in cyd@ .",
"data were available for @ of the @ participants ( @ % ) in the cyd@ trial included in cyd@ .",
"during year @ in the cyd@ , cyd@ , and cyd@ trials combined , hospitalization for virologically confirmed dengue occurred in @ of @,@ participants in the vaccine group and @ of @,@ participants in the control group .",
"pooled relative risks of hospitalization for dengue were @ ( @ % confidence interval -lsb- ci -rsb- , @ to @ ) among all participants , @ ( @ % ci , @ to @ ) among those under the age of @ years , and @ ( @ % ci , @ to @ ) among those @ years of age or older .",
"during year @ , hospitalization for severe dengue , as defined by the independent data monitoring committee criteria , occurred in @ of @,@ participants in the vaccine group and @ of @,@ participants in the control group .",
"pooled rates of efficacy for symptomatic dengue during the first @ months were @ % ( @ % ci , @ to @ ) for all participants , @ % ( @ % ci , @ to @ ) for those @ years of age or older , and @ % ( @ % ci , @ to @ ) for those younger than @ years of age .",
"although the unexplained higher incidence of hospitalization for dengue in year @ among children younger than @ years of age needs to be carefully monitored during long-term follow-up , the risk among children @ to @ years of age was lower in the vaccine group than in the control group .",
"( funded by sanofi pasteur ; clinicaltrials.gov numbers , nct@ , nct@ , nct@ , and nct@ . )"
] | a candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than @,@ children between the ages of @ and @ years in asian-pacific and latin american countries . we report the results of long-term follow-up interim analyses and integrated efficacy analyses . we are assessing the incidence of hospitalization for virologically confirmed dengue as a surrogate safety end point during follow-up in years @ to @ of two phase @ trials , cyd@ and cyd@ , and a phase @b trial , cyd@/@ . we estimated vaccine efficacy using pooled data from the first @ months of cyd@ and cyd@ . follow-up data were available for @,@ of @,@ participants ( @ % ) in cyd@ and @,@ of @,@ participants ( @ % ) in cyd@ . data were available for @ of the @ participants ( @ % ) in the cyd@ trial included in cyd@ . during year @ in the cyd@ , cyd@ , and cyd@ trials combined , hospitalization for virologically confirmed dengue occurred in @ of @,@ participants in the vaccine group and @ of @,@ participants in the control group . pooled relative risks of hospitalization for dengue were @ ( @ % confidence interval -lsb- ci -rsb- , @ to @ ) among all participants , @ ( @ % ci , @ to @ ) among those under the age of @ years , and @ ( @ % ci , @ to @ ) among those @ years of age or older . during year @ , hospitalization for severe dengue , as defined by the independent data monitoring committee criteria , occurred in @ of @,@ participants in the vaccine group and @ of @,@ participants in the control group . pooled rates of efficacy for symptomatic dengue during the first @ months were @ % ( @ % ci , @ to @ ) for all participants , @ % ( @ % ci , @ to @ ) for those @ years of age or older , and @ % ( @ % ci , @ to @ ) for those younger than @ years of age . although the unexplained higher incidence of hospitalization for dengue in year @ among children younger than @ years of age needs to be carefully monitored during long-term follow-up , the risk among children @ to @ years of age was lower in the vaccine group than in the control group . ( funded by sanofi pasteur ; clinicaltrials.gov numbers , nct@ , nct@ , nct@ , and nct@ . ) | 26,214,039 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"with regard to clinicopathological findings and disease prognosis , breast cancer in young women is different from that in older women .",
"however , few studies have investigated magnetic resonance imaging ( mri ) characteristics of young age-onset breast cancer .",
"to retrospectively evaluate and compare the mr images and clinicopathological characteristics of invasive breast cancer in young women ( aged < @ years ) with those of breast cancers in older premenopausal women ( @-@ years ) .",
"a total of @ invasive breast cancers in @ premenopausal women aged @ years and younger who underwent preoperative breast mri and curative surgery were identified between @ and @ .",
"the subjects were divided into a young group ( < @ years , n = @ ) and an older group ( @-@ years , n = @ ) .",
"mri features and clinicopathological data were compared between the two groups .",
"the young group had more positive axillary lymph nodes , higher histologic grade , negative estrogen receptor ( er ) , negative progesterone receptor ( pr ) , and higher p@ and ki-@ expression compared to the older group .",
"using mri , the young group was more likely to display a round/oval or lobular mass shape , a smooth mass margin , and a high signal intensity on t@-weighted images when compared to the older group .",
"in multivariate analysis , positive axillary nodal status ( adjusted odds ratio -lsb- or -rsb- , @ ; p = @ ) , higher expression of p@ ( adjusted or , @ ; p = @ ) , lobular mass shape ( adjusted or , @ ; p = @ ) , and smooth mass margin ( adjusted or , @ ; p = @ ) were independently associated with the young group .",
"mr morphologic features , including lobular mass shape and smooth mass margin , were independently associated with breast cancer in young women , in addition to positive axillary nodal status and higher p@ expression status ."
] | with regard to clinicopathological findings and disease prognosis , breast cancer in young women is different from that in older women . however , few studies have investigated magnetic resonance imaging ( mri ) characteristics of young age-onset breast cancer . to retrospectively evaluate and compare the mr images and clinicopathological characteristics of invasive breast cancer in young women ( aged < @ years ) with those of breast cancers in older premenopausal women ( @-@ years ) . a total of @ invasive breast cancers in @ premenopausal women aged @ years and younger who underwent preoperative breast mri and curative surgery were identified between @ and @ . the subjects were divided into a young group ( < @ years , n = @ ) and an older group ( @-@ years , n = @ ) . mri features and clinicopathological data were compared between the two groups . the young group had more positive axillary lymph nodes , higher histologic grade , negative estrogen receptor ( er ) , negative progesterone receptor ( pr ) , and higher p@ and ki-@ expression compared to the older group . using mri , the young group was more likely to display a round/oval or lobular mass shape , a smooth mass margin , and a high signal intensity on t@-weighted images when compared to the older group . in multivariate analysis , positive axillary nodal status ( adjusted odds ratio -lsb- or -rsb- , @ ; p = @ ) , higher expression of p@ ( adjusted or , @ ; p = @ ) , lobular mass shape ( adjusted or , @ ; p = @ ) , and smooth mass margin ( adjusted or , @ ; p = @ ) were independently associated with the young group . mr morphologic features , including lobular mass shape and smooth mass margin , were independently associated with breast cancer in young women , in addition to positive axillary nodal status and higher p@ expression status . | 25,024,441 | [
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"cisplatin plus @-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer .",
"however , cisplatin has several disadvantages , including renal toxicity and the need for admission .",
"s-@ plus cisplatin has become a standard treatment for advanced gastric cancer in east asia .",
"this phase iii study was designed to evaluate the potential benefits of adding docetaxel to s-@ without a platinum compound in patients with advanced gastric cancer .",
"patients were randomly assigned to receive docetaxel plus s-@ or s-@ alone .",
"the docetaxel plus s-@ group received docetaxel on day @ and oral s-@ on days @-@ of a @-day cycle .",
"the s-@ alone group received oral s-@ on days @-@ of a @-day cycle .",
"the primary end point was overall survival .",
"of the @ patients enrolled , @ were eligible for analysis .",
"the median overall survival was @ months in the docetaxel plus s-@ group and @ months in the s-@ alone group ( p = @ ) .",
"the median progression-free survival was @ months in the docetaxel plus s-@ group and @ months in the s-@ alone group ( p = @ ) .",
"as for adverse events , neutropenia was more frequent in the docetaxel plus s-@ group , but remained manageable .",
"as first-line treatment for advanced gastric cancer , docetaxel plus s-@ significantly improves median overall and progression-free survival as compared with s-@ alone .",
"( clinicaltrials.gov number : nct@ ) ."
] | cisplatin plus @-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer . however , cisplatin has several disadvantages , including renal toxicity and the need for admission . s-@ plus cisplatin has become a standard treatment for advanced gastric cancer in east asia . this phase iii study was designed to evaluate the potential benefits of adding docetaxel to s-@ without a platinum compound in patients with advanced gastric cancer . patients were randomly assigned to receive docetaxel plus s-@ or s-@ alone . the docetaxel plus s-@ group received docetaxel on day @ and oral s-@ on days @-@ of a @-day cycle . the s-@ alone group received oral s-@ on days @-@ of a @-day cycle . the primary end point was overall survival . of the @ patients enrolled , @ were eligible for analysis . the median overall survival was @ months in the docetaxel plus s-@ group and @ months in the s-@ alone group ( p = @ ) . the median progression-free survival was @ months in the docetaxel plus s-@ group and @ months in the s-@ alone group ( p = @ ) . as for adverse events , neutropenia was more frequent in the docetaxel plus s-@ group , but remained manageable . as first-line treatment for advanced gastric cancer , docetaxel plus s-@ significantly improves median overall and progression-free survival as compared with s-@ alone . ( clinicaltrials.gov number : nct@ ) . | 24,366,758 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"clinical skills expertise can be advanced through accessible and cost-effective video-based observational practice activities .",
"previous findings suggest that the observation of performances of skills that include flaws can be beneficial to trainees .",
"observing the scope of variability within a skilled movement allows learners to develop strategies to manage the potential for and consequences associated with errors .",
"this study tests this observational learning approach on the development of the skills of central line insertion ( cli ) .",
"medical trainees with no cli experience ( n = @ ) were randomised to three observational practice groups : a group which viewed and assessed videos of an expert performing a cli without any errors ( f ) ; a group which viewed and assessed videos that contained a mix of flawless and errorful performances ( e ) , and a group which viewed the same videos as the e group but were also given information concerning the correctness of their assessments ( fa ) .",
"all participants interacted with their observational videos each day for @ days .",
"following this period , participants returned to the laboratory and performed a simulation-based insertion , which was assessed using a standard checklist and a global rating scale for the skill .",
"these ratings served as the dependent measures for analysis .",
"the checklist analysis revealed no differences between observational learning groups ( grand mean standard error : -lsb- @ @ -rsb- / @ ) .",
"however , the global rating analysis revealed a main effect of group ( d.f. @,@ = @ , p = @ ) , which describes better cli performance in the fa group , compared with the f and e groups .",
"observational practice that includes errors improves the global performance aspects of clinical skill learning as long as learners are given confirmation that what they are observing is errorful .",
"these findings provide a refined perspective on the optimal organisation of skill education programmes that combine physical and observational practice activities ."
] | clinical skills expertise can be advanced through accessible and cost-effective video-based observational practice activities . previous findings suggest that the observation of performances of skills that include flaws can be beneficial to trainees . observing the scope of variability within a skilled movement allows learners to develop strategies to manage the potential for and consequences associated with errors . this study tests this observational learning approach on the development of the skills of central line insertion ( cli ) . medical trainees with no cli experience ( n = @ ) were randomised to three observational practice groups : a group which viewed and assessed videos of an expert performing a cli without any errors ( f ) ; a group which viewed and assessed videos that contained a mix of flawless and errorful performances ( e ) , and a group which viewed the same videos as the e group but were also given information concerning the correctness of their assessments ( fa ) . all participants interacted with their observational videos each day for @ days . following this period , participants returned to the laboratory and performed a simulation-based insertion , which was assessed using a standard checklist and a global rating scale for the skill . these ratings served as the dependent measures for analysis . the checklist analysis revealed no differences between observational learning groups ( grand mean standard error : -lsb- @ @ -rsb- / @ ) . however , the global rating analysis revealed a main effect of group ( d.f. @,@ = @ , p = @ ) , which describes better cli performance in the fa group , compared with the f and e groups . observational practice that includes errors improves the global performance aspects of clinical skill learning as long as learners are given confirmation that what they are observing is errorful . these findings provide a refined perspective on the optimal organisation of skill education programmes that combine physical and observational practice activities . | 25,626,749 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to examine the association between individual drug use and peer leaders use .",
"analysis of drug use behaviors of @ students randomized into three arms-control , standard , and networked where peers serve as group leaders .",
"among the combined male and female group , there was no association between peer leader and individual use .",
"among males , peer leader use at baseline was positively associated with individual alcohol use at post-test .",
"among females , peer leader use at post-test was negatively associated with marijuana and cigarette use .",
"having peer leaders in the network condition decreased the odds of marijuana and cigarette use among females .",
"the opposite effect was found in males ."
] | to examine the association between individual drug use and peer leaders use . analysis of drug use behaviors of @ students randomized into three arms-control , standard , and networked where peers serve as group leaders . among the combined male and female group , there was no association between peer leader and individual use . among males , peer leader use at baseline was positively associated with individual alcohol use at post-test . among females , peer leader use at post-test was negatively associated with marijuana and cigarette use . having peer leaders in the network condition decreased the odds of marijuana and cigarette use among females . the opposite effect was found in males . | 25,407,377 | [
"OBJECTIVE",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"pylorus-preserving pancreatoduodenectomy ( pppd ) has been associated with a high incidence of delayed gastric emptying ( dge ) .",
"there are few studies comparing dge associated with pppd and subtotal stomach-preserving pancreatoduodenectomy ( ssppd ) .",
"moreover , differences between the procedures with respect to long-term results have not been reported .",
"a prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with pppd and ssppd .",
"one hundred patients with periampullary lesions were randomized to receive either pppd ( n = @ ) or ssppd ( n = @ ) .",
"all patients were followed up for @ years after surgery or to the time of recurrence to evaluate nutritional status for the study .",
"the effects of the procedure , age , and malignancy on changes in nutritional indicators were estimated with linear mixed models .",
"this study was registered at umin clinical trials registry ( umin @ ) .",
"the incidence of dge assessed by the international study group of pancreatic surgery was @ % with pppd and @ % with ssppd ( p = @ ) .",
"there were no significant differences between the two procedures on postoperative serum albumin levels , serum total cholesterol levels , and body mass index during the @-year follow-up period .",
"ssppd is equally effective in dge occurrence rate and long-term nutritional status comparing to pppd ."
] | pylorus-preserving pancreatoduodenectomy ( pppd ) has been associated with a high incidence of delayed gastric emptying ( dge ) . there are few studies comparing dge associated with pppd and subtotal stomach-preserving pancreatoduodenectomy ( ssppd ) . moreover , differences between the procedures with respect to long-term results have not been reported . a prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with pppd and ssppd . one hundred patients with periampullary lesions were randomized to receive either pppd ( n = @ ) or ssppd ( n = @ ) . all patients were followed up for @ years after surgery or to the time of recurrence to evaluate nutritional status for the study . the effects of the procedure , age , and malignancy on changes in nutritional indicators were estimated with linear mixed models . this study was registered at umin clinical trials registry ( umin @ ) . the incidence of dge assessed by the international study group of pancreatic surgery was @ % with pppd and @ % with ssppd ( p = @ ) . there were no significant differences between the two procedures on postoperative serum albumin levels , serum total cholesterol levels , and body mass index during the @-year follow-up period . ssppd is equally effective in dge occurrence rate and long-term nutritional status comparing to pppd . | 24,619,624 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to evaluate the effectiveness of two subsequent intervention components ( motivational and self-regulatory components ) , placed in different order , to promote fruit and vegetable ( fv ) intake .",
"after baseline assessment , university students ( n = @ , aged @-@ years ) were allocated to two groups .",
"one group received a motivational intervention ( outcome expectancies , risk perception , and task self-efficacy ) followed by a self-regulatory intervention ( planning and dietary self-efficacy ) after @ days .",
"the second group received the same intervention conditions in the opposite order .",
"follow-up assessments were done after another @ days .",
"both intervention sequences yielded gains in terms of fv intake and self-efficacy .",
"however , this gain was only due to the self-regulatory component whereas the motivational component did not contribute to the changes .",
"moreover , changes in intention and self-efficacy mediated between intervention sequence and follow-up behavior , suggesting that improving these proximal predictors of fv intake was responsible for the behavioral gains .",
"findings highlight the superiority of a self-regulatory intervention over a motivational intervention when it comes to dietary changes in this sample of young adults .",
"moreover , changes in dietary self-efficacy may drive nutritional changes ."
] | to evaluate the effectiveness of two subsequent intervention components ( motivational and self-regulatory components ) , placed in different order , to promote fruit and vegetable ( fv ) intake . after baseline assessment , university students ( n = @ , aged @-@ years ) were allocated to two groups . one group received a motivational intervention ( outcome expectancies , risk perception , and task self-efficacy ) followed by a self-regulatory intervention ( planning and dietary self-efficacy ) after @ days . the second group received the same intervention conditions in the opposite order . follow-up assessments were done after another @ days . both intervention sequences yielded gains in terms of fv intake and self-efficacy . however , this gain was only due to the self-regulatory component whereas the motivational component did not contribute to the changes . moreover , changes in intention and self-efficacy mediated between intervention sequence and follow-up behavior , suggesting that improving these proximal predictors of fv intake was responsible for the behavioral gains . findings highlight the superiority of a self-regulatory intervention over a motivational intervention when it comes to dietary changes in this sample of young adults . moreover , changes in dietary self-efficacy may drive nutritional changes . | 25,049,137 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to assess the relative impact of an intensive lifestyle intervention ( ili ) on use and costs of health care within the look ahead trial .",
"a total of @,@ overweight or obese adults with type @ diabetes were randomly assigned to an ili that promoted weight loss or to a comparison condition of diabetes support and education ( dse ) .",
"use and costs of health-care services were recorded across an average of @ years .",
"ili led to reductions in annual hospitalizations ( @ % , p = @ ) , hospital days ( @ % , p = @ ) , and number of medications ( @ % , p < @ ) , resulting in cost savings for hospitalization ( @ % , p = @ ) and medication ( @ % , p < @ ) .",
"ili produced a mean relative per-person @-year cost savings of $ @,@ ( @ % ci @,@-@ ,@ ) ; however , these were not evident among individuals with a history of cardiovascular disease .",
"compared with dse over @ years , ili participants had fewer hospitalizations , fewer medications , and lower health-care costs ."
] | to assess the relative impact of an intensive lifestyle intervention ( ili ) on use and costs of health care within the look ahead trial . a total of @,@ overweight or obese adults with type @ diabetes were randomly assigned to an ili that promoted weight loss or to a comparison condition of diabetes support and education ( dse ) . use and costs of health-care services were recorded across an average of @ years . ili led to reductions in annual hospitalizations ( @ % , p = @ ) , hospital days ( @ % , p = @ ) , and number of medications ( @ % , p < @ ) , resulting in cost savings for hospitalization ( @ % , p = @ ) and medication ( @ % , p < @ ) . ili produced a mean relative per-person @-year cost savings of $ @,@ ( @ % ci @,@-@ ,@ ) ; however , these were not evident among individuals with a history of cardiovascular disease . compared with dse over @ years , ili participants had fewer hospitalizations , fewer medications , and lower health-care costs . | 25,147,253 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to compare tidal breathing on different continuous positive airway pressure ( cpap ) devices and pressures and to serially measure tidal breathing during weaning off cpap using electromagnetic inductive plethysmography .",
"using electromagnetic inductive plethysmography , tidal breathing was measured in @ preterm infants receiving cpap , gestational age @ @ weeks .",
"variable-flow nasal cpap ( ncpap ) , bubble cpap ( bcpap ) at pressures of @ , @ , and @ cmh@o , nasal bi-level positive airway pressure ( nbipap ) system at pressures of @ , @/@ , and @/@ cmh@o , and unsupported breathing were studied .",
"twenty-one infants had weekly tidal breathing measurements on and off ncpap .",
"minute volume ( mv/kg ) was similar between all devices ( @-@ @ l/kg/min ) .",
"on bcpap , weight corrected tidal volume ( vt/kg ) was the least , changing little with increasing pressures .",
"on ncpap and nbipap , vt/kg increased with increasing pressure and the respiratory rate ( fr ) decreased .",
"the delivered pressure varied slightly from the set pressure being most dissimilar on nbipap and similar on bcpap .",
"compared with unsupported breathing , all devices decreased vt/kg , mv/kg , and phase angle , but did not alter fr .",
"serial tidal breathing measurements showed decreasing difference for vt/kg over time on and off ncpap .",
"at different pressure settings , on all cpap devices the measured mv/kg was similar either through increasing vt/kg and decreasing fr ( ncpap and nbipap ) or maintaining both ( bcpap ) .",
"serial tidal breathing measurements may aid weaning from cpap ."
] | to compare tidal breathing on different continuous positive airway pressure ( cpap ) devices and pressures and to serially measure tidal breathing during weaning off cpap using electromagnetic inductive plethysmography . using electromagnetic inductive plethysmography , tidal breathing was measured in @ preterm infants receiving cpap , gestational age @ @ weeks . variable-flow nasal cpap ( ncpap ) , bubble cpap ( bcpap ) at pressures of @ , @ , and @ cmh@o , nasal bi-level positive airway pressure ( nbipap ) system at pressures of @ , @/@ , and @/@ cmh@o , and unsupported breathing were studied . twenty-one infants had weekly tidal breathing measurements on and off ncpap . minute volume ( mv/kg ) was similar between all devices ( @-@ @ l/kg/min ) . on bcpap , weight corrected tidal volume ( vt/kg ) was the least , changing little with increasing pressures . on ncpap and nbipap , vt/kg increased with increasing pressure and the respiratory rate ( fr ) decreased . the delivered pressure varied slightly from the set pressure being most dissimilar on nbipap and similar on bcpap . compared with unsupported breathing , all devices decreased vt/kg , mv/kg , and phase angle , but did not alter fr . serial tidal breathing measurements showed decreasing difference for vt/kg over time on and off ncpap . at different pressure settings , on all cpap devices the measured mv/kg was similar either through increasing vt/kg and decreasing fr ( ncpap and nbipap ) or maintaining both ( bcpap ) . serial tidal breathing measurements may aid weaning from cpap . | 24,518,163 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"epidemiologic data suggest that low serum @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- increases insulin resistance and the risk of type @ diabetes .",
"few interventional trials have assessed the effect of vitamin d on insulin metabolism , and published results are discordant .",
"the goal of this study was to perform a detailed assessment of the effect of ergocalciferol administration on glucose and insulin metabolism in healthy people with low total @ ( oh ) d ( total ) .",
"this was a @-wk , double-blinded , randomized controlled trial .",
"we enrolled @ healthy volunteers aged @-@ y with serum @ ( oh ) d @ ng/ml ( by immunoassay ) and administered @,@ iu ergocalciferol/wk or placebo for @ wk .",
"primary endpoints were change in first-phase insulin response and insulin sensitivity as measured by intravenous glucose tolerance test .",
"secondary endpoints included change in homeostasis model assessment of insulin resistance ; fasting glucose , insulin , and lipids ; body mass index ( bmi ) ; and blood pressure .",
"on-study @ ( oh ) d ( total ) was assessed by liquid chromatography-tandem mass spectrometry .",
"in the treated group , @ ( oh ) d ( total ) rose from @ @ to @ @ ng/ml ( p < @ ) with no change in the placebo group .",
"despite this increase , at @ wk , there were no between-group differences in either insulin response or insulin sensitivity ; nor were there differences in any measured secondary endpoints .",
"there was no evidence of effect modification by sex , race , glucose tolerance status , baseline @ ( oh ) d ( total ) , or bmi .",
"in healthy persons with low @ ( oh ) d ( total ) , ergocalciferol administration for @ wk normalizes @ ( oh ) d ( total ) but does not improve insulin secretion , insulin sensitivity , or other markers of metabolic health ."
] | epidemiologic data suggest that low serum @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- increases insulin resistance and the risk of type @ diabetes . few interventional trials have assessed the effect of vitamin d on insulin metabolism , and published results are discordant . the goal of this study was to perform a detailed assessment of the effect of ergocalciferol administration on glucose and insulin metabolism in healthy people with low total @ ( oh ) d ( total ) . this was a @-wk , double-blinded , randomized controlled trial . we enrolled @ healthy volunteers aged @-@ y with serum @ ( oh ) d @ ng/ml ( by immunoassay ) and administered @,@ iu ergocalciferol/wk or placebo for @ wk . primary endpoints were change in first-phase insulin response and insulin sensitivity as measured by intravenous glucose tolerance test . secondary endpoints included change in homeostasis model assessment of insulin resistance ; fasting glucose , insulin , and lipids ; body mass index ( bmi ) ; and blood pressure . on-study @ ( oh ) d ( total ) was assessed by liquid chromatography-tandem mass spectrometry . in the treated group , @ ( oh ) d ( total ) rose from @ @ to @ @ ng/ml ( p < @ ) with no change in the placebo group . despite this increase , at @ wk , there were no between-group differences in either insulin response or insulin sensitivity ; nor were there differences in any measured secondary endpoints . there was no evidence of effect modification by sex , race , glucose tolerance status , baseline @ ( oh ) d ( total ) , or bmi . in healthy persons with low @ ( oh ) d ( total ) , ergocalciferol administration for @ wk normalizes @ ( oh ) d ( total ) but does not improve insulin secretion , insulin sensitivity , or other markers of metabolic health . | 26,156,733 | [
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"the high prevalence of physical inactivity has led to a search for novel and feasible interventions that will enhance physical activity , especially among the least physically active individuals .",
"this randomized controlled trial aimed to determine the effectiveness of a value-based intervention to promote a physically more active lifestyle among physically inactive adults .",
"the framework of the study was based on acceptance and commitment therapy ( act ) .",
"physically inactive participants aged @ to @years ( n = @ ) were randomly allocated to a feedback ( fb , n = @ ) or an acceptance - and commitment-based group ( act+fb , n = @ ) .",
"both groups received written feedback about their objectively measured physical activity and were offered a body composition analysis .",
"in addition , the participants in the act+fb group attended six group sessions and were given a pedometer for self-monitoring their physical activity during the nine-week intervention .",
"the primary outcome was physical activity .",
"in addition , participants ' cognitions related to exercise and physical activity were evaluated at baseline and at three - and six-month follow-ups .",
"the changes in mean physical activity level were analysed using multilevel random regression and rank order stability , using the structural equation model .",
"participants in both groups increased their objectively measured and self-reported physical activity with high individual differences .",
"no difference was observed in the change of physical activity level between the fb and act+fb groups over time .",
"however , the cognitions related to physical activity and exercise improved more in the act+fb group than in the fb group .",
"in addition , after re-analyzing the data among the non-depressive participants , higher stability was observed in objectively measured physical activity at the individual level between the three - and six-month follow-ups in the act+fb group as compared to fb group .",
"acceptance - and commitment-based group intervention , combined with the self-monitoring of physical activity , was beneficial in supporting the cognition related to exercise and physical activity , and brought more stability to the individual level physical activity behaviour change , especially among the non-depressive participants .",
"clinicaltrials.gov , number nct@ .",
"registered in february @ ."
] | the high prevalence of physical inactivity has led to a search for novel and feasible interventions that will enhance physical activity , especially among the least physically active individuals . this randomized controlled trial aimed to determine the effectiveness of a value-based intervention to promote a physically more active lifestyle among physically inactive adults . the framework of the study was based on acceptance and commitment therapy ( act ) . physically inactive participants aged @ to @years ( n = @ ) were randomly allocated to a feedback ( fb , n = @ ) or an acceptance - and commitment-based group ( act+fb , n = @ ) . both groups received written feedback about their objectively measured physical activity and were offered a body composition analysis . in addition , the participants in the act+fb group attended six group sessions and were given a pedometer for self-monitoring their physical activity during the nine-week intervention . the primary outcome was physical activity . in addition , participants ' cognitions related to exercise and physical activity were evaluated at baseline and at three - and six-month follow-ups . the changes in mean physical activity level were analysed using multilevel random regression and rank order stability , using the structural equation model . participants in both groups increased their objectively measured and self-reported physical activity with high individual differences . no difference was observed in the change of physical activity level between the fb and act+fb groups over time . however , the cognitions related to physical activity and exercise improved more in the act+fb group than in the fb group . in addition , after re-analyzing the data among the non-depressive participants , higher stability was observed in objectively measured physical activity at the individual level between the three - and six-month follow-ups in the act+fb group as compared to fb group . acceptance - and commitment-based group intervention , combined with the self-monitoring of physical activity , was beneficial in supporting the cognition related to exercise and physical activity , and brought more stability to the individual level physical activity behaviour change , especially among the non-depressive participants . clinicaltrials.gov , number nct@ . registered in february @ . | 25,848,812 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"BACKGROUND",
"BACKGROUND"
] |
[
"we investigated cardiac proinflammatory , mitogenic , and apoptotic signaling events , and plasma biomarkers of inflammation and oxidative stress in de novo adult cardiac transplant ( ctx ) patients receiving tacrolimus ( tac ) or cyclosporine a ( csa ) .",
"one hundred ctx recipients were randomized @:@ to tac/csa in a prospective , randomized open-label multicenter study .",
"biomarkers of inflammation , immunity , oxidative stress , and cardiac signaling underlying growth and inflammation ( extracellular signal-related kinase @/@ , p@ mitogen-activated protein kinase , mitogen-activated protein kinase kinases -lsb- mek -rsb- @/@ and @/@ , c-src ) , and apoptosis and survival ( c-jun nh@-terminal kinases -lsb- jnk -rsb- , bax/bcl@ , akt ) were assessed at @ , @ , @ , @ , and @ weeks post-ctx .",
"plasma from healthy controls ( n = @ ) and tissue from explanted non-failing hearts ( n = @ ) were used as controls .",
"biomarkers of inflammation/immunity ( interleukin -@ and -@ , soluble intercellular adhesion molecule , e-selectin , monocyte chemoattractant protein-@ , osteopontin , fibrinogen , n-terminal prohormone brain natriuretic peptide , high-sensitive c-reactive protein ) and oxidative stress ( thiobarbituric acid reactive substances , nitrotyrosine ) were increased , and antioxidant capacity was ( glutathione/glutathione disulfide ) decreased in patients vs healthy controls ( p < @ ) .",
"phosphorylation of mitogen-activated protein kinases and akt was increased , and bax/bcl was decreased in transplanted vs non-transplanted hearts .",
"except for plasma fibrinogen , which was lower in tac vs. csa , ( p = @ ) , there were no significant differences in parameters studied between tac vs csa immunoprophylaxis .",
"de novo ctx recipients exhibit significant sub-clinical inflammation and oxidative stress that persists @ months after transplantation .",
"associated with this is activation of myocardial growth and inflammatory signaling and decreased apoptosis .",
"our findings suggest that ctx is an inflammatory condition associated with oxidative stress and myocardial growth regardless of csa or tac immunoprophylaxis and independently of rejection status ."
] | we investigated cardiac proinflammatory , mitogenic , and apoptotic signaling events , and plasma biomarkers of inflammation and oxidative stress in de novo adult cardiac transplant ( ctx ) patients receiving tacrolimus ( tac ) or cyclosporine a ( csa ) . one hundred ctx recipients were randomized @:@ to tac/csa in a prospective , randomized open-label multicenter study . biomarkers of inflammation , immunity , oxidative stress , and cardiac signaling underlying growth and inflammation ( extracellular signal-related kinase @/@ , p@ mitogen-activated protein kinase , mitogen-activated protein kinase kinases -lsb- mek -rsb- @/@ and @/@ , c-src ) , and apoptosis and survival ( c-jun nh@-terminal kinases -lsb- jnk -rsb- , bax/bcl@ , akt ) were assessed at @ , @ , @ , @ , and @ weeks post-ctx . plasma from healthy controls ( n = @ ) and tissue from explanted non-failing hearts ( n = @ ) were used as controls . biomarkers of inflammation/immunity ( interleukin -@ and -@ , soluble intercellular adhesion molecule , e-selectin , monocyte chemoattractant protein-@ , osteopontin , fibrinogen , n-terminal prohormone brain natriuretic peptide , high-sensitive c-reactive protein ) and oxidative stress ( thiobarbituric acid reactive substances , nitrotyrosine ) were increased , and antioxidant capacity was ( glutathione/glutathione disulfide ) decreased in patients vs healthy controls ( p < @ ) . phosphorylation of mitogen-activated protein kinases and akt was increased , and bax/bcl was decreased in transplanted vs non-transplanted hearts . except for plasma fibrinogen , which was lower in tac vs. csa , ( p = @ ) , there were no significant differences in parameters studied between tac vs csa immunoprophylaxis . de novo ctx recipients exhibit significant sub-clinical inflammation and oxidative stress that persists @ months after transplantation . associated with this is activation of myocardial growth and inflammatory signaling and decreased apoptosis . our findings suggest that ctx is an inflammatory condition associated with oxidative stress and myocardial growth regardless of csa or tac immunoprophylaxis and independently of rejection status . | 24,263,023 | [
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to test whether a prolonged @-hour infusion of meropenem @mg achieves an equivalent proportion of time above the minimal inhibitory concentration ( mic ) ( % tmic ) to that of meropenem @mg given over @ minutes .",
"a randomised crossover study in @ critically ill patients .",
"we administered meropenem as a @mg , @-minute infusion or as a @mg , @-hour infusion .",
"we determined serial plasma concentrations for each dosing episode and performed comparisons of % tmic at different mics .",
"the percentage of time that meropenem was above its mic .",
"for low mics ( @ mg/l ) , both regimens attained a % tmic > @ % in all patients .",
"for an mic of @mg/l , this target was attained in all but one patient , but with an mic of @mg/l , three patients in each group had a % tmic < @ % .",
"there was no difference in target attainment between the two regimens for mics up to @mg/l .",
"there was marked variability in the pharmacokinetic and hence the pharmacokinetic-pharmacodynamic parameters between individuals .",
"several patients had elevated creatinine clearances and , with both regimens , their target attainment was poor .",
"meropenem at @mg over @ minutes achieved a similar % tmic to meropenem at @mg given over @ hours .",
"meropenem pharmacokinetics were highly variable from individual to individual ."
] | to test whether a prolonged @-hour infusion of meropenem @mg achieves an equivalent proportion of time above the minimal inhibitory concentration ( mic ) ( % tmic ) to that of meropenem @mg given over @ minutes . a randomised crossover study in @ critically ill patients . we administered meropenem as a @mg , @-minute infusion or as a @mg , @-hour infusion . we determined serial plasma concentrations for each dosing episode and performed comparisons of % tmic at different mics . the percentage of time that meropenem was above its mic . for low mics ( @ mg/l ) , both regimens attained a % tmic > @ % in all patients . for an mic of @mg/l , this target was attained in all but one patient , but with an mic of @mg/l , three patients in each group had a % tmic < @ % . there was no difference in target attainment between the two regimens for mics up to @mg/l . there was marked variability in the pharmacokinetic and hence the pharmacokinetic-pharmacodynamic parameters between individuals . several patients had elevated creatinine clearances and , with both regimens , their target attainment was poor . meropenem at @mg over @ minutes achieved a similar % tmic to meropenem at @mg given over @ hours . meropenem pharmacokinetics were highly variable from individual to individual . | 25,161,021 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"probiotic bacteria have been shown to have various effects on the microbiota ; this may also affect appetite and may help promote weight loss and maintenance .",
"this study was conducted to investigate the effect of lactobacillus paracasei subsp paracasei l. casei w@ ( l. casei w@ ) on glucagon-like peptide-@ ( glp-@ ) responses in an isolated pig intestine , in piglets and postprandially in humans .",
"additionally , the effect on subjective appetite , ad libitum energy intake , and glucose and insulin responses in humans was investigated .",
"piglets were fed with probiotics for @ weeks and the effect on glucagon encoding gene ( gcg ) was investigated .",
"an isolated pig intestine was perfused with l. casei w@ and the glp-@ response was measured .",
"twenty-one subjects completed a randomized , controlled , crossover study with three arms .",
"each participant completed @ test days testing the effect of low dose ( ld ) ( @ ( @ ) cfu ) , high dose ( hd ) ( @ ( @ ) cfu ) l. casei w@ or placebo capsule .",
"subjective appetite was assessed before an ad libitum lunch was served .",
"glp-@ , insulin and glucose concentrations were analyzed .",
"two weeks of treatment of piglets with l. casei w@ resulted in an increase in gcg expression compared to control animals ( p < @ ) .",
"l. casei w@ increased the glp-@ response in the isolated pig intestine .",
"in humans , l. casei w@ had an overall effect on energy intake ( p = @ ) , but no effects on subjective appetite sensation , overall glucose and insulin response and on glp-@ release were observed ( p > @ ) .",
"the probiotic bacteria l. casei w@ appears to lower food intake acutely , but the underlying mechanisms are not understood ."
] | probiotic bacteria have been shown to have various effects on the microbiota ; this may also affect appetite and may help promote weight loss and maintenance . this study was conducted to investigate the effect of lactobacillus paracasei subsp paracasei l. casei w@ ( l. casei w@ ) on glucagon-like peptide-@ ( glp-@ ) responses in an isolated pig intestine , in piglets and postprandially in humans . additionally , the effect on subjective appetite , ad libitum energy intake , and glucose and insulin responses in humans was investigated . piglets were fed with probiotics for @ weeks and the effect on glucagon encoding gene ( gcg ) was investigated . an isolated pig intestine was perfused with l. casei w@ and the glp-@ response was measured . twenty-one subjects completed a randomized , controlled , crossover study with three arms . each participant completed @ test days testing the effect of low dose ( ld ) ( @ ( @ ) cfu ) , high dose ( hd ) ( @ ( @ ) cfu ) l. casei w@ or placebo capsule . subjective appetite was assessed before an ad libitum lunch was served . glp-@ , insulin and glucose concentrations were analyzed . two weeks of treatment of piglets with l. casei w@ resulted in an increase in gcg expression compared to control animals ( p < @ ) . l. casei w@ increased the glp-@ response in the isolated pig intestine . in humans , l. casei w@ had an overall effect on energy intake ( p = @ ) , but no effects on subjective appetite sensation , overall glucose and insulin response and on glp-@ release were observed ( p > @ ) . the probiotic bacteria l. casei w@ appears to lower food intake acutely , but the underlying mechanisms are not understood . | 25,049,132 | [
"BACKGROUND",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"this study was designed to evaluate the role of maintenance therapy with partially hydrolyzed guar gum ( phgg ) after topical application of glyceryl trinitrate ( gtn ) in the conservative treatment of chronic anal fissure ( caf ) .",
"from all the patients with caf observed during the study period , @ subjects with healed caf after standard therapy with topical gtn @ % ointment were randomized to receive ( group ii ) or not ( group i ) maintenance therapy with phgg for @ months .",
"clinical and manometric followup was carried out @ and @ months after treatment .",
"at six-month followup , median visual analogue scale score was significantly higher in group i if compared with group ii .",
"the success and recurrence rate at @-month followup were , respectively , @ % ( @/@ ) in group i versus @ % ( @/@ ) in group ii ( p = @ ; fisher 's exact test ) and @ % ( @/@ ) in group i versus @ % ( @/@ ) in group ii ( p = @ ; fisher 's exact test ) .",
"the maintenance therapy with phgg in patients with healed caf after chemical sphincterotomy by topical application of gtn @ % ointment seems associated with a significant reduction of recurrence rate and with a significant increase of success rate at @-month followup ."
] | this study was designed to evaluate the role of maintenance therapy with partially hydrolyzed guar gum ( phgg ) after topical application of glyceryl trinitrate ( gtn ) in the conservative treatment of chronic anal fissure ( caf ) . from all the patients with caf observed during the study period , @ subjects with healed caf after standard therapy with topical gtn @ % ointment were randomized to receive ( group ii ) or not ( group i ) maintenance therapy with phgg for @ months . clinical and manometric followup was carried out @ and @ months after treatment . at six-month followup , median visual analogue scale score was significantly higher in group i if compared with group ii . the success and recurrence rate at @-month followup were , respectively , @ % ( @/@ ) in group i versus @ % ( @/@ ) in group ii ( p = @ ; fisher 's exact test ) and @ % ( @/@ ) in group i versus @ % ( @/@ ) in group ii ( p = @ ; fisher 's exact test ) . the maintenance therapy with phgg in patients with healed caf after chemical sphincterotomy by topical application of gtn @ % ointment seems associated with a significant reduction of recurrence rate and with a significant increase of success rate at @-month followup . | 25,089,280 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to determine the effects of an intensive lifestyle intervention versus a comparison group on body composition in obese or overweight persons with type @ diabetes at baseline and at @ , @ , and @ years .",
"body composition was measured by dual-energy x-ray absorptiometry in a subset of @ look ahead study volunteers randomized to intervention or comparison groups .",
"the intervention was designed to achieve and maintain @ % weight loss through increased physical activity and reduced caloric intake .",
"the comparison group received social support and diabetes education .",
"at @ year , the intervention group lost fat ( @ kg ) and lean mass ( @ kg ) but regained fat ( @ % ) and lost lean mass between years @ and @ .",
"between baseline and year @ , weight loss was greater in intervention versus comparison groups ( @ vs. @ kg ) ; comparison group weight loss was mostly lean mass ( @ kg ) .",
"fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points .",
"reduced fat mass may place the intervention group at a lower risk of obesity-linked sequelae , a hypothesis that can be tested by future studies of this cohort ."
] | to determine the effects of an intensive lifestyle intervention versus a comparison group on body composition in obese or overweight persons with type @ diabetes at baseline and at @ , @ , and @ years . body composition was measured by dual-energy x-ray absorptiometry in a subset of @ look ahead study volunteers randomized to intervention or comparison groups . the intervention was designed to achieve and maintain @ % weight loss through increased physical activity and reduced caloric intake . the comparison group received social support and diabetes education . at @ year , the intervention group lost fat ( @ kg ) and lean mass ( @ kg ) but regained fat ( @ % ) and lost lean mass between years @ and @ . between baseline and year @ , weight loss was greater in intervention versus comparison groups ( @ vs. @ kg ) ; comparison group weight loss was mostly lean mass ( @ kg ) . fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points . reduced fat mass may place the intervention group at a lower risk of obesity-linked sequelae , a hypothesis that can be tested by future studies of this cohort . | 25,707,379 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"relations between fibroblast growth factor-@ ( fgf-@ ) , soluble - klotho ( s -- klotho ) , and kidney function in chronic kidney disease ( ckd ) are still unclear .",
"especially the role of s -- klotho requires further study .",
"our objectives were to analyze the relation of s -- klotho to estimated glomerular filtration rate ( egfr ) , fgf-@ , and other parameters of calcium-phosphate metabolism and to investigate the response of s -- klotho to cholecalciferol .",
"twenty-four ckd ( stage @-@ ) patients participated in this @-week randomized controlled trial ( vitamin d and chronic renal insufficiency ) .",
"interventions included @ @ iu cholecalciferol or placebo weekly .",
"s -- klotho was determined by elisa with antihuman klotho antibodies @g@ and @f@ .",
"for all patients , s -- klotho concentrations did not differ between ckd stages .",
"when patients were subdivided based on fgf-@ concentrations , a positive association of s -- klotho with egfr became apparent in patients with lower than median fgf-@ concentrations but not in those above median value .",
"patients with s -- klotho below @ pg/ml showed higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase compared with patients with higher s -- klotho .",
"treatment with cholecalciferol significantly increased @,@-dihydroxyvitamin d.",
"the increase of fgf-@ had only borderline significance .",
"there was no significant effect of high-dose cholecalciferol administration for @ weeks on plasma s -- klotho .",
"ckd patients with s -- klotho below @ pg/ml had higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase .",
"an association of s -- klotho with egfr was observed only in the presence of close to normal , but not high , fgf-@ concentrations .",
"cholecalciferol treatment did not change s -- klotho concentrations ."
] | relations between fibroblast growth factor-@ ( fgf-@ ) , soluble - klotho ( s -- klotho ) , and kidney function in chronic kidney disease ( ckd ) are still unclear . especially the role of s -- klotho requires further study . our objectives were to analyze the relation of s -- klotho to estimated glomerular filtration rate ( egfr ) , fgf-@ , and other parameters of calcium-phosphate metabolism and to investigate the response of s -- klotho to cholecalciferol . twenty-four ckd ( stage @-@ ) patients participated in this @-week randomized controlled trial ( vitamin d and chronic renal insufficiency ) . interventions included @ @ iu cholecalciferol or placebo weekly . s -- klotho was determined by elisa with antihuman klotho antibodies @g@ and @f@ . for all patients , s -- klotho concentrations did not differ between ckd stages . when patients were subdivided based on fgf-@ concentrations , a positive association of s -- klotho with egfr became apparent in patients with lower than median fgf-@ concentrations but not in those above median value . patients with s -- klotho below @ pg/ml showed higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase compared with patients with higher s -- klotho . treatment with cholecalciferol significantly increased @,@-dihydroxyvitamin d. the increase of fgf-@ had only borderline significance . there was no significant effect of high-dose cholecalciferol administration for @ weeks on plasma s -- klotho . ckd patients with s -- klotho below @ pg/ml had higher age , lower phosphate clearance , and lower bone-specific alkaline phosphatase . an association of s -- klotho with egfr was observed only in the presence of close to normal , but not high , fgf-@ concentrations . cholecalciferol treatment did not change s -- klotho concentrations . | 24,606,097 | [
"BACKGROUND",
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"the purpose of this study was to evaluate a traditional herbal preparation , jobelyn , for its effects on anemia and cd@ + t-cell counts in human immunodeficiency virus-positive ( hiv + ) patients in nigeria .",
"an open-label pilot study involving @ confirmed ( hiv + ) patients who were not receiving antiretroviral therapy ( arvt ) was performed , in which the patients consumed jobelyn for @ weeks , at a dose of @mg twice daily .",
"the pilot study was followed by a controlled trial involving @ patients , all confirmed hiv + , where the patients with cd@ + t-cell counts below @ cells/l were receiving arvt .",
"the eight patients with baseline cd@ + t-cell counts above @ cells/l received jobelyn .",
"the remaining patients who all received arvt were randomized to arvt alone versus arvt+j obelyn for @ weeks .",
"patients receiving arvt showed a statistically significant improvement in their cd@ + t-cell counts across the @-week study period ( p < @ ) .",
"patients receiving arvt+j obelyn showed a faster improvement , reaching a high level of statistical significance compared to baseline already at @ weeks ( p < @ ) , and remained highly significant at @ weeks ( p < @ ) .",
"this is the first controlled study conducted to evaluate efficacy of jobelyn on immune status in hiv + patients .",
"the data suggest that consumption of jobelyn contributed to improved hemoglobin levels and increased cd@ + t-cell counts in nigerian hiv + patients .",
"further studies are needed to examine similar effects in other populations , and to elaborate on the underlying mechanisms , specifically , whether the consumption of jobelyn supported multiple aspects of bone marrow function ."
] | the purpose of this study was to evaluate a traditional herbal preparation , jobelyn , for its effects on anemia and cd@ + t-cell counts in human immunodeficiency virus-positive ( hiv + ) patients in nigeria . an open-label pilot study involving @ confirmed ( hiv + ) patients who were not receiving antiretroviral therapy ( arvt ) was performed , in which the patients consumed jobelyn for @ weeks , at a dose of @mg twice daily . the pilot study was followed by a controlled trial involving @ patients , all confirmed hiv + , where the patients with cd@ + t-cell counts below @ cells/l were receiving arvt . the eight patients with baseline cd@ + t-cell counts above @ cells/l received jobelyn . the remaining patients who all received arvt were randomized to arvt alone versus arvt+j obelyn for @ weeks . patients receiving arvt showed a statistically significant improvement in their cd@ + t-cell counts across the @-week study period ( p < @ ) . patients receiving arvt+j obelyn showed a faster improvement , reaching a high level of statistical significance compared to baseline already at @ weeks ( p < @ ) , and remained highly significant at @ weeks ( p < @ ) . this is the first controlled study conducted to evaluate efficacy of jobelyn on immune status in hiv + patients . the data suggest that consumption of jobelyn contributed to improved hemoglobin levels and increased cd@ + t-cell counts in nigerian hiv + patients . further studies are needed to examine similar effects in other populations , and to elaborate on the underlying mechanisms , specifically , whether the consumption of jobelyn supported multiple aspects of bone marrow function . | 24,283,768 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"this study aims to evaluate the immediate effect of a global pelvic manipulation ( gpm ) technique , bilaterally applied , on low back pelvic pain in women with primary dysmenorrhea ( pd ) .",
"a prospective , randomized , double-blind , controlled trial .",
"faculty of nursing , physiotherapy and podiatry .",
"university of sevilla , spain .",
"the sample group included @ women ( @ @ years ) that were divided into an experimental group ( eg ) ( n = @ ) who underwent a bilateral gpm technique and a control group ( cg ) ( n = @ ) who underwent a sham ( placebo ) intervention .",
"evaluations were made of self-reported low back pelvic pain ( visual analog scale ) , pressure pain threshold ( ppt ) in sacroiliac joints ( sijs ) , and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels .",
"the intragroup comparison showed a significant improvement in the eg in the self-perceived low back pelvic pain ( p = @ ) and in the mechanosensitivity in both sijs ( p = @ ) .",
"in the between-group comparison , there was a decrease in pain perception ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) and an increase in the ppt of both sijs , in the right side ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) and in the left side ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) .",
"there were no intergroup differences for catecholamines plasma levels ( adrenaline p = @ ; noradrenaline p = @ ; dopamine p = @ ) , but there were for serotonin levels ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) .",
"the bilateral gpm technique improves in a short term the self-perceived low back pelvic pain , the ppt in both sijs , and the serotonin levels in women with pd .",
"it shows no significant differences with a sham intervention in catecholamines plasma levels ."
] | this study aims to evaluate the immediate effect of a global pelvic manipulation ( gpm ) technique , bilaterally applied , on low back pelvic pain in women with primary dysmenorrhea ( pd ) . a prospective , randomized , double-blind , controlled trial . faculty of nursing , physiotherapy and podiatry . university of sevilla , spain . the sample group included @ women ( @ @ years ) that were divided into an experimental group ( eg ) ( n = @ ) who underwent a bilateral gpm technique and a control group ( cg ) ( n = @ ) who underwent a sham ( placebo ) intervention . evaluations were made of self-reported low back pelvic pain ( visual analog scale ) , pressure pain threshold ( ppt ) in sacroiliac joints ( sijs ) , and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels . the intragroup comparison showed a significant improvement in the eg in the self-perceived low back pelvic pain ( p = @ ) and in the mechanosensitivity in both sijs ( p = @ ) . in the between-group comparison , there was a decrease in pain perception ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) and an increase in the ppt of both sijs , in the right side ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) and in the left side ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) . there were no intergroup differences for catecholamines plasma levels ( adrenaline p = @ ; noradrenaline p = @ ; dopamine p = @ ) , but there were for serotonin levels ( p = @ ; f ( @,@ ) = @ ; r ( @ ) = @ ) . the bilateral gpm technique improves in a short term the self-perceived low back pelvic pain , the ppt in both sijs , and the serotonin levels in women with pd . it shows no significant differences with a sham intervention in catecholamines plasma levels . | 24,666,560 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses mri inflammation and halts structural damage progression in patients with early rheumatoid arthritis ( era ) , and whether adalimumab provides an additional effect .",
"in a double-blind , placebo-controlled trial , @ disease-modifying antirheumatic drug-nave patients with era were randomised to receive methotrexate , intra-articular glucocorticosteroid injections and placebo/adalimumab ( @/@ ) .",
"contrast-enhanced mri of the right hand was performed at months @ , @ and @ .",
"synovitis , osteitis , tenosynovitis , mri bone erosion and joint space narrowing ( jsn ) were scored with validated methods .",
"dynamic contrast-enhanced mri ( dce-mri ) was carried out in @ patients .",
"synovitis , osteitis and tenosynovitis scores decreased highly significantly ( p < @ ) during the @-months ' follow-up , with mean change scores of -@ ( median -@ ) , -@ ( -@ ) and -@ ( -@ ) , respectively .",
"no overall change in mri bone erosion and jsn scores was seen , with change scores of @ ( @ ) and @ ( @ ) .",
"the tenosynovitis score at month @ was significantly lower in the adalimumab group , @ ( @ ) , than in the placebo group , @ ( @ ) , mann-whitney : p < @ .",
"furthermore , the osteitis score decreased significantly during the @-months ' follow-up in the adalimumab group , but not in the placebo group , wilcoxon : p = @-@ @ and p = @-@ @ .",
"dce-mri parameters correlated closely with conventional mri inflammatory parameters .",
"clinical measures decreased highly significantly during follow-up .",
"a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with era effectively decreased synovitis , osteitis and tenosynovitis and halted structural damage progression as judged by mri .",
"the findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis ."
] | to investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses mri inflammation and halts structural damage progression in patients with early rheumatoid arthritis ( era ) , and whether adalimumab provides an additional effect . in a double-blind , placebo-controlled trial , @ disease-modifying antirheumatic drug-nave patients with era were randomised to receive methotrexate , intra-articular glucocorticosteroid injections and placebo/adalimumab ( @/@ ) . contrast-enhanced mri of the right hand was performed at months @ , @ and @ . synovitis , osteitis , tenosynovitis , mri bone erosion and joint space narrowing ( jsn ) were scored with validated methods . dynamic contrast-enhanced mri ( dce-mri ) was carried out in @ patients . synovitis , osteitis and tenosynovitis scores decreased highly significantly ( p < @ ) during the @-months ' follow-up , with mean change scores of -@ ( median -@ ) , -@ ( -@ ) and -@ ( -@ ) , respectively . no overall change in mri bone erosion and jsn scores was seen , with change scores of @ ( @ ) and @ ( @ ) . the tenosynovitis score at month @ was significantly lower in the adalimumab group , @ ( @ ) , than in the placebo group , @ ( @ ) , mann-whitney : p < @ . furthermore , the osteitis score decreased significantly during the @-months ' follow-up in the adalimumab group , but not in the placebo group , wilcoxon : p = @-@ @ and p = @-@ @ . dce-mri parameters correlated closely with conventional mri inflammatory parameters . clinical measures decreased highly significantly during follow-up . a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with era effectively decreased synovitis , osteitis and tenosynovitis and halted structural damage progression as judged by mri . the findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis . | 24,412,895 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"this report describes the result of prospective randomized trial to assess effectiveness and safety of neoadjuvant photodynamic therapy ( pdt ) and chemotherapy as well as possibility for further surgery for locally advanced nsclc .",
"patients with stage iiia and iiib central nsclc ( main bronchus/distal trachea involvement ) who were not initially eligible for surgery but might be considered as surgery candidates after neoadjuvant therapy were enrolled in the study .",
"they were randomized to either neoadjuvant chemotherapy and endobronchial pdt or chemotherapy alone followed by surgical resection .",
"pdt was done with photosensitizer agent chlorine e@ and @nm laser light before each of the three courses of chemotherapy .",
"from january @ to december @ , @ patients were assigned to pdt arm ( n = @ ) and no-pdt arm ( n = @ ) .",
"groups were similar with respect to age , sex , tumor stage , and histology .",
"no pdt major complications were observed .",
"after neoadjuvant treatment partial response revealed in @pts ( @ % ) in pdt arm and @pts ( @ % ) in no-pdt arm ( p = @ ) , these patients underwent thoracotomy .",
"after thoracotomy tumor was unresectable in @pts of no-pdt arm ( @ % ) .",
"there were @ pneumonectomies and @ lobectomies in pdt arm vs. @ pneumonectomies and @ lobectomies in no-pdt arm .",
"completeness of resection was significantly higher in pdt arm ( r@-@ % , r@-@ % ) vs. no-pdt arm ( r@-@ % , r@-@ % ) , p = @ .",
"the study demonstrated that neoadjuvant pdt along with chemotherapy is effective , safe and it makes possible to convert to surgery candidates and to improve resection completeness in stage iii central nsclc patients ."
] | this report describes the result of prospective randomized trial to assess effectiveness and safety of neoadjuvant photodynamic therapy ( pdt ) and chemotherapy as well as possibility for further surgery for locally advanced nsclc . patients with stage iiia and iiib central nsclc ( main bronchus/distal trachea involvement ) who were not initially eligible for surgery but might be considered as surgery candidates after neoadjuvant therapy were enrolled in the study . they were randomized to either neoadjuvant chemotherapy and endobronchial pdt or chemotherapy alone followed by surgical resection . pdt was done with photosensitizer agent chlorine e@ and @nm laser light before each of the three courses of chemotherapy . from january @ to december @ , @ patients were assigned to pdt arm ( n = @ ) and no-pdt arm ( n = @ ) . groups were similar with respect to age , sex , tumor stage , and histology . no pdt major complications were observed . after neoadjuvant treatment partial response revealed in @pts ( @ % ) in pdt arm and @pts ( @ % ) in no-pdt arm ( p = @ ) , these patients underwent thoracotomy . after thoracotomy tumor was unresectable in @pts of no-pdt arm ( @ % ) . there were @ pneumonectomies and @ lobectomies in pdt arm vs. @ pneumonectomies and @ lobectomies in no-pdt arm . completeness of resection was significantly higher in pdt arm ( r@-@ % , r@-@ % ) vs. no-pdt arm ( r@-@ % , r@-@ % ) , p = @ . the study demonstrated that neoadjuvant pdt along with chemotherapy is effective , safe and it makes possible to convert to surgery candidates and to improve resection completeness in stage iii central nsclc patients . | 24,704,942 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"to determine the safety and efficacy of low-voltage , external-beam , stereotactic radiotherapy ( srt ) for patients with neovascular age-related macular degeneration ( amd ) .",
"randomized , double-masked , sham-controlled , multicenter , clinical trial .",
"a total of @ participants with neovascular amd who received @ ranibizumab or bevacizumab injections within the preceding year and requiring treatment at enrollment .",
"participants received @ gray , @ gray , or sham srt .",
"all arms received pro re nata ( prn ) ranibizumab for @ months , with prn bevacizumab or ranibizumab thereafter .",
"mean number of prn injections ; best-corrected visual acuity ( bcva ) ; loss of < @ early treatment of diabetic retinopathy study letters ; change in optical coherence tomography central subfield thickness ; and change in angiographic total lesion area and choroidal neovascularization ( cnv ) area .",
"at year @ , the @ and @ gray arms received fewer prn treatments compared with sham ( mean @ , p = @ ; mean @ , p = @ ; and mean @ , respectively ) .",
"change in mean bcva was -@ , -@ , and -@ letters for the @ gray , @ gray , and sham arms , respectively , with @ ( @ % ) , @ ( @ % ) , and @ participants ( @ % ) , respectively , losing < @ letters .",
"mean central subfield thickness decreased by @ m , @ m , and @ m , respectively .",
"mean total active lesion area increased by @ , @ , and @ mm ( @ ) , respectively .",
"mean cnv area decreased by @ mm ( @ ) in all groups .",
"an independent reading center detected microvascular abnormalities in @ control eyes and @ srt eyes , of which @ were attributed to radiation ; however , only @ of these possibly affected vision .",
"an exploratory subgroup analysis found that lesions with a greatest linear dimension @ mm ( the size of the treatment zone ) and a macular volume greater than the median ( @ mm ( @ ) ) were more responsive to srt , with @ prn injections versus @ in comparable sham-treated participants ( p = @ ) and mean bcva @ letters superior to sham ( p = @ ) .",
"a single dose of srt significantly reduces intravitreal injections over @ years .",
"radiation can induce microvascular change , but in only @ % of eyes does this possibly affect vision .",
"the best response occurs when amd lesions fit within the treatment zone and they are actively leaking ."
] | to determine the safety and efficacy of low-voltage , external-beam , stereotactic radiotherapy ( srt ) for patients with neovascular age-related macular degeneration ( amd ) . randomized , double-masked , sham-controlled , multicenter , clinical trial . a total of @ participants with neovascular amd who received @ ranibizumab or bevacizumab injections within the preceding year and requiring treatment at enrollment . participants received @ gray , @ gray , or sham srt . all arms received pro re nata ( prn ) ranibizumab for @ months , with prn bevacizumab or ranibizumab thereafter . mean number of prn injections ; best-corrected visual acuity ( bcva ) ; loss of < @ early treatment of diabetic retinopathy study letters ; change in optical coherence tomography central subfield thickness ; and change in angiographic total lesion area and choroidal neovascularization ( cnv ) area . at year @ , the @ and @ gray arms received fewer prn treatments compared with sham ( mean @ , p = @ ; mean @ , p = @ ; and mean @ , respectively ) . change in mean bcva was -@ , -@ , and -@ letters for the @ gray , @ gray , and sham arms , respectively , with @ ( @ % ) , @ ( @ % ) , and @ participants ( @ % ) , respectively , losing < @ letters . mean central subfield thickness decreased by @ m , @ m , and @ m , respectively . mean total active lesion area increased by @ , @ , and @ mm ( @ ) , respectively . mean cnv area decreased by @ mm ( @ ) in all groups . an independent reading center detected microvascular abnormalities in @ control eyes and @ srt eyes , of which @ were attributed to radiation ; however , only @ of these possibly affected vision . an exploratory subgroup analysis found that lesions with a greatest linear dimension @ mm ( the size of the treatment zone ) and a macular volume greater than the median ( @ mm ( @ ) ) were more responsive to srt , with @ prn injections versus @ in comparable sham-treated participants ( p = @ ) and mean bcva @ letters superior to sham ( p = @ ) . a single dose of srt significantly reduces intravitreal injections over @ years . radiation can induce microvascular change , but in only @ % of eyes does this possibly affect vision . the best response occurs when amd lesions fit within the treatment zone and they are actively leaking . | 25,208,859 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"uk national institute of health and clinical excellence guidelines for obsessive compulsive disorder ( ocd ) specify recommendations for the treatment and management of ocd using a stepped care approach .",
"steps three to six of this model recommend treatment options for people with ocd that range from low-intensity guided self-help ( gsh ) to more intensive psychological and pharmacological interventions .",
"cognitive behavioural therapy ( cbt ) , including exposure and response prevention , is the recommended psychological treatment .",
"however , whilst there is some preliminary evidence that self-managed therapy packages for ocd can be effective , a more robust evidence base of their clinical and cost effectiveness and acceptability is required .",
"our proposed study will test two different self-help treatments for ocd : @ ) computerised cbt ( ccbt ) using ocfighter , an internet-delivered ocd treatment package ; and @ ) gsh using a book .",
"both treatments will be accompanied by email or telephone support from a mental health professional .",
"we will evaluate the effectiveness , cost and patient and health professional acceptability of the treatments .",
"this study will provide more robust evidence of efficacy , cost effectiveness and acceptability of self-help treatments for ocd .",
"if ccbt and/or gsh prove effective , it will provide additional , more accessible treatment options for people with ocd .",
"current controlled trials : isrctn@ .",
"date of registration : @ april @ ."
] | uk national institute of health and clinical excellence guidelines for obsessive compulsive disorder ( ocd ) specify recommendations for the treatment and management of ocd using a stepped care approach . steps three to six of this model recommend treatment options for people with ocd that range from low-intensity guided self-help ( gsh ) to more intensive psychological and pharmacological interventions . cognitive behavioural therapy ( cbt ) , including exposure and response prevention , is the recommended psychological treatment . however , whilst there is some preliminary evidence that self-managed therapy packages for ocd can be effective , a more robust evidence base of their clinical and cost effectiveness and acceptability is required . our proposed study will test two different self-help treatments for ocd : @ ) computerised cbt ( ccbt ) using ocfighter , an internet-delivered ocd treatment package ; and @ ) gsh using a book . both treatments will be accompanied by email or telephone support from a mental health professional . we will evaluate the effectiveness , cost and patient and health professional acceptability of the treatments . this study will provide more robust evidence of efficacy , cost effectiveness and acceptability of self-help treatments for ocd . if ccbt and/or gsh prove effective , it will provide additional , more accessible treatment options for people with ocd . current controlled trials : isrctn@ . date of registration : @ april @ . | 25,011,730 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"CONCLUSIONS",
"CONCLUSIONS",
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"BACKGROUND"
] |
[
"the prodigy trial ( prevention of long term social disability amongst young people with emerging psychological difficulties , isrctn@ ) is a pilot trial of social recovery cognitive-behavioural therapy ( srcbt ) .",
"the prodigy qualitative substudy aimed to ( a ) explore individual experiences of participating in the pilot randomised , controlled trial ( recruitment , randomisation , assessment ) and initial views of therapy , and ( b ) to explore perceived benefits of taking part in research v. ethical concerns and potential risks .",
"qualitative investigation using semi-structured interviews with thematic analysis .",
"analysis revealed participant experiences around the key themes of acceptability , disclosure , practicalities , altruism and engagement .",
"participants in both trial arms perceived themselves as gaining benefits from being involved in the study , above and beyond the intervention .",
"this has implications for the design of future research and services for this client group , highlighting the importance of being flexible and an individualised approach as key engagement tools ."
] | the prodigy trial ( prevention of long term social disability amongst young people with emerging psychological difficulties , isrctn@ ) is a pilot trial of social recovery cognitive-behavioural therapy ( srcbt ) . the prodigy qualitative substudy aimed to ( a ) explore individual experiences of participating in the pilot randomised , controlled trial ( recruitment , randomisation , assessment ) and initial views of therapy , and ( b ) to explore perceived benefits of taking part in research v. ethical concerns and potential risks . qualitative investigation using semi-structured interviews with thematic analysis . analysis revealed participant experiences around the key themes of acceptability , disclosure , practicalities , altruism and engagement . participants in both trial arms perceived themselves as gaining benefits from being involved in the study , above and beyond the intervention . this has implications for the design of future research and services for this client group , highlighting the importance of being flexible and an individualised approach as key engagement tools . | 25,431,429 | [
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"the purpose of this study was to test causal effects of physicians ' nonverbal involvement on medical error disclosure outcomes .",
"@ hospital outpatients were randomly assigned to two experimental treatment groups .",
"the first group watched a video vignette of a verbally effective and nonverbally involved error disclosure .",
"the second group was exposed to a verbally effective but nonverbally uninvolved error disclosure .",
"all patients responded to seven outcome measures .",
"patients in the nonverbally uninvolved error disclosure treatment group perceived the physician 's apology as less sincere and remorseful compared to patients in the involved disclosure group .",
"they also rated the implications of the error as more severe , were more likely to ascribe fault to the physician , and indicated a higher intent to change doctors after the disclosure .",
"the results of this study imply that nonverbal involvement during medical error disclosures facilitates more accurate patient understanding and assessment of the medical error and its consequences on their health and quality of life .",
"in the context of disclosing medical errors , nonverbal involvement increases the likelihood that physicians will be able to continue caring for their patient .",
"thus , providers are advised to consider adopting this communication skill into their medical practice ."
] | the purpose of this study was to test causal effects of physicians ' nonverbal involvement on medical error disclosure outcomes . @ hospital outpatients were randomly assigned to two experimental treatment groups . the first group watched a video vignette of a verbally effective and nonverbally involved error disclosure . the second group was exposed to a verbally effective but nonverbally uninvolved error disclosure . all patients responded to seven outcome measures . patients in the nonverbally uninvolved error disclosure treatment group perceived the physician 's apology as less sincere and remorseful compared to patients in the involved disclosure group . they also rated the implications of the error as more severe , were more likely to ascribe fault to the physician , and indicated a higher intent to change doctors after the disclosure . the results of this study imply that nonverbal involvement during medical error disclosures facilitates more accurate patient understanding and assessment of the medical error and its consequences on their health and quality of life . in the context of disclosing medical errors , nonverbal involvement increases the likelihood that physicians will be able to continue caring for their patient . thus , providers are advised to consider adopting this communication skill into their medical practice . | 24,332,933 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to study changes in the nuclear factor-b p@ ( nf-b p@ ) - inducible nitric oxide synthase ( inos ) - nitric oxide ( no ) signaling pathway and the effects of xinfeng capsules ( xfc ) in patients with ankylosing spondylitis ( as ) .",
"one hundred twenty patients with as were randomly divided into an xfc group and a salazopyrin group .",
"sixty health subjects were included as a normal control group .",
"in the two treatment groups , pulmonary functional parameters , forced vital capacity ( fvc ) , forced expiratory volume in @ second ( fev@ ) , maximal voluntary ventilation ( mvv ) , peak expiratory flow ( pef ) , forced expiratory flow at @ % of forced vital capacity ( fef@ ) , forced expiratory flow at @ % of forced vital capacity ( fef@ ) , and forced expiratory flow at @ % of forced vital capacity ( fef@ ) were determined .",
"enzyme linked immunosorbent assays were used for detection of the serum oxidative stress indexes , nf-b p@ , inos , no , reactive oxygen species ( ros ) , reactive nitrogen species ( rns ) , malondialdehyde ( mda ) , superoxide dismutase ( sod ) , catalase ( cat ) , total antioxidative capacity ( taoc ) and interleukin-@ ( il-@ ) , il-@ , il-@ , and tumor necrosis factor - ( tnf - ) contents .",
"westergren 's method was used for determination of erythrocyte sedimentation rate ( esr ) .",
"high-sensitivity c-reactive protein ( hs-crp ) was detected with a @ full-automatic biochemical analyzer ( hitachi , japan ) .",
"the clinical therapeutic effect in the xfc group was significantly superior to that in the salazopyrin group ( p < @ ) .",
"compared with the normal control group , fev@ , mvv , pef , fef@ , fef@ , sod , cat , taoc , il-@ , il-@ were significantly lower , and nf-b p@ , inos , no , ros , rns , mda , il-@ , tnf - , esr , and hs-crp significantly higher in patients with as ( p < @ or p < @ ) .",
"compared with before treatment , fev@ , mvv , pef , fef@ , fef@ , sod , cat , taoc , il-@ , and il-@ were significantly increased , and nf-b p@ , inos , no , ros , rns , mda , il-@ , tnf - , esr , crp , visual analog scales ( vas ) , bath ankylosing spondylitis disease active index , bath ankylosing spondylitis functional index , and bath ankylosing spondylitis global index significantly decreased in the two treatment groups after treatment ( p < .",
"@ or p < @ ) , with significant differences between the xfc and salazopyrin groups ( p < @ or p < @ ) .",
"spearman correlation analysis indicated that fev@ , mwvv , pef , fef@ , and fef@ were positively correlated with sod , cat , taoc , il-@ , and il-@ , and were negatively correlated with nf-b p@ , inos , no , ros , rns , mda , il-@ , tnf - , esr , and crp .",
"patients with as have local pathologic changes in the spinal cord and other joints .",
"they also have decreased pulmonary function , which is negatively correlated with the nf-b-inos-no signaling pathway , oxidative indexes , and inflammatory factors .",
"xfc improves rigidity and pain in spinal joints and other symptoms , laboratory indexes , and pulmonary function .",
"the mechanism is possibly related to inhibition of the nf-kb-inos-no signaling pathway ."
] | to study changes in the nuclear factor-b p@ ( nf-b p@ ) - inducible nitric oxide synthase ( inos ) - nitric oxide ( no ) signaling pathway and the effects of xinfeng capsules ( xfc ) in patients with ankylosing spondylitis ( as ) . one hundred twenty patients with as were randomly divided into an xfc group and a salazopyrin group . sixty health subjects were included as a normal control group . in the two treatment groups , pulmonary functional parameters , forced vital capacity ( fvc ) , forced expiratory volume in @ second ( fev@ ) , maximal voluntary ventilation ( mvv ) , peak expiratory flow ( pef ) , forced expiratory flow at @ % of forced vital capacity ( fef@ ) , forced expiratory flow at @ % of forced vital capacity ( fef@ ) , and forced expiratory flow at @ % of forced vital capacity ( fef@ ) were determined . enzyme linked immunosorbent assays were used for detection of the serum oxidative stress indexes , nf-b p@ , inos , no , reactive oxygen species ( ros ) , reactive nitrogen species ( rns ) , malondialdehyde ( mda ) , superoxide dismutase ( sod ) , catalase ( cat ) , total antioxidative capacity ( taoc ) and interleukin-@ ( il-@ ) , il-@ , il-@ , and tumor necrosis factor - ( tnf - ) contents . westergren 's method was used for determination of erythrocyte sedimentation rate ( esr ) . high-sensitivity c-reactive protein ( hs-crp ) was detected with a @ full-automatic biochemical analyzer ( hitachi , japan ) . the clinical therapeutic effect in the xfc group was significantly superior to that in the salazopyrin group ( p < @ ) . compared with the normal control group , fev@ , mvv , pef , fef@ , fef@ , sod , cat , taoc , il-@ , il-@ were significantly lower , and nf-b p@ , inos , no , ros , rns , mda , il-@ , tnf - , esr , and hs-crp significantly higher in patients with as ( p < @ or p < @ ) . compared with before treatment , fev@ , mvv , pef , fef@ , fef@ , sod , cat , taoc , il-@ , and il-@ were significantly increased , and nf-b p@ , inos , no , ros , rns , mda , il-@ , tnf - , esr , crp , visual analog scales ( vas ) , bath ankylosing spondylitis disease active index , bath ankylosing spondylitis functional index , and bath ankylosing spondylitis global index significantly decreased in the two treatment groups after treatment ( p < . @ or p < @ ) , with significant differences between the xfc and salazopyrin groups ( p < @ or p < @ ) . spearman correlation analysis indicated that fev@ , mwvv , pef , fef@ , and fef@ were positively correlated with sod , cat , taoc , il-@ , and il-@ , and were negatively correlated with nf-b p@ , inos , no , ros , rns , mda , il-@ , tnf - , esr , and crp . patients with as have local pathologic changes in the spinal cord and other joints . they also have decreased pulmonary function , which is negatively correlated with the nf-b-inos-no signaling pathway , oxidative indexes , and inflammatory factors . xfc improves rigidity and pain in spinal joints and other symptoms , laboratory indexes , and pulmonary function . the mechanism is possibly related to inhibition of the nf-kb-inos-no signaling pathway . | 25,618,969 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"to describe the health-related quality of life ( hrqol ) burden of cervical dystonia ( cd ) and report on the hrqol and patient perception of treatment benefits of abobotulinumtoxina ( dysport ) .",
"the safety and efficacy of a single injection of abobotulinumtoxina for cd treatment were evaluated in a previously reported international , multicenter , double-blind , randomised trial .",
"hrqol measures were assessed in the trial and have not been previously reported .",
"movement disorder clinics in the usa and russia .",
"patients had to have a diagnosis of cd with symptoms for at least @months , as well as a total toronto western spasmodic torticollis rating scale ( twstrs ) score of at least @ ; a severity domain score of at least @ ; and a disability domain score of at least @ .",
"key exclusion criteria included treatment with botulinum toxin type a ( bont-a ) or botulinum toxin type b ( bont-b ) within @weeks of enrolment .",
"patients were randomised to receive either @ u abobotulinumtoxina ( n = @ ) or placebo ( n = @ ) .",
"efficacy assessments included twstrs total ( primary end point ) and subscale scores at weeks @ , @ , @ , @ ; a pain visual analogue scale at weeks @ and @ ; and hrqol assessed by the sf-@ health survey ( sf-@ ; secondary end point ) at weeks @ and @ .",
"patients with cd reported significantly greater impairment for all sf-@ domains relative to us norms .",
"patients treated with abobotulinumtoxina reported significantly greater improvements in physical functioning , role physical , bodily pain , general health and role emotional domains than placebo patients ( p@ @ for all ) .",
"the twstrs was significantly correlated with physical functioning , role physical and bodily pain scores , for those on active treatment .",
"cd has a marked impact on hrqol .",
"treatment with a single abobotulinumtoxina injection results in significant improvement in patients ' hrqol .",
"the trial is registered at clinicaltrials.gov , numbers nct@ and nct@ ."
] | to describe the health-related quality of life ( hrqol ) burden of cervical dystonia ( cd ) and report on the hrqol and patient perception of treatment benefits of abobotulinumtoxina ( dysport ) . the safety and efficacy of a single injection of abobotulinumtoxina for cd treatment were evaluated in a previously reported international , multicenter , double-blind , randomised trial . hrqol measures were assessed in the trial and have not been previously reported . movement disorder clinics in the usa and russia . patients had to have a diagnosis of cd with symptoms for at least @months , as well as a total toronto western spasmodic torticollis rating scale ( twstrs ) score of at least @ ; a severity domain score of at least @ ; and a disability domain score of at least @ . key exclusion criteria included treatment with botulinum toxin type a ( bont-a ) or botulinum toxin type b ( bont-b ) within @weeks of enrolment . patients were randomised to receive either @ u abobotulinumtoxina ( n = @ ) or placebo ( n = @ ) . efficacy assessments included twstrs total ( primary end point ) and subscale scores at weeks @ , @ , @ , @ ; a pain visual analogue scale at weeks @ and @ ; and hrqol assessed by the sf-@ health survey ( sf-@ ; secondary end point ) at weeks @ and @ . patients with cd reported significantly greater impairment for all sf-@ domains relative to us norms . patients treated with abobotulinumtoxina reported significantly greater improvements in physical functioning , role physical , bodily pain , general health and role emotional domains than placebo patients ( p@ @ for all ) . the twstrs was significantly correlated with physical functioning , role physical and bodily pain scores , for those on active treatment . cd has a marked impact on hrqol . treatment with a single abobotulinumtoxina injection results in significant improvement in patients ' hrqol . the trial is registered at clinicaltrials.gov , numbers nct@ and nct@ . | 25,324,317 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND"
] |
[
"the prognostic utility of circulating plasma microrna in patients with acute coronary syndromes ( acs ) has been proposed but not yet demonstrated .",
"we set out to investigate circulating microrna levels in patients incurring recent acs and examined associations with neurohormones , cardiac structure and function , and survival over @ years of follow-up .",
"an initial screen of @ micrornas was performed in @ acs patients and @ healthy controls .",
"candidates identified from the initial screen ( mir-@-@p , mir-@ , mir-@b , mir-@ and mir-@a ) were validated in a further cohort of @ patients at baseline ( ~ @ days post-acs ) and at @ and @ months post-acs , and compared with @ controls .",
"in the validation cohort , significantly higher levels in patients were replicated for mir-@-@p , mir-@ and mir-@b ( @-fold , @-fold and @-fold , respectively , adjusted p < @ ) .",
"lower levels of mir-@ were not replicated and mir-@a was undetectable .",
"from baseline to @ months post-admission , mir-@-@p and mir-@ remained elevated in patients compared to controls ( adjusted p < @ ) , with no further change in levels between @ and @ months ; whereas mir-@b fell to control levels by @ months .",
"baseline levels of mir-@ in the lowest tertile were significantly associated with readmission for heart failure ( log-rank p < @ ) .",
"in combination with nt-probnp and lvef , mir-@ significantly improved risk stratification ( p < @ ) .",
"our study identifies mir-@ as a novel candidate biomarker for post-acs prognosis beyond existing biomarkers of lvef and nt-probnp .",
"moreover circulating mir-@-@p was markedly elevated in patients for at least a year post-acs and may be a stable biomarker for acs ."
] | the prognostic utility of circulating plasma microrna in patients with acute coronary syndromes ( acs ) has been proposed but not yet demonstrated . we set out to investigate circulating microrna levels in patients incurring recent acs and examined associations with neurohormones , cardiac structure and function , and survival over @ years of follow-up . an initial screen of @ micrornas was performed in @ acs patients and @ healthy controls . candidates identified from the initial screen ( mir-@-@p , mir-@ , mir-@b , mir-@ and mir-@a ) were validated in a further cohort of @ patients at baseline ( ~ @ days post-acs ) and at @ and @ months post-acs , and compared with @ controls . in the validation cohort , significantly higher levels in patients were replicated for mir-@-@p , mir-@ and mir-@b ( @-fold , @-fold and @-fold , respectively , adjusted p < @ ) . lower levels of mir-@ were not replicated and mir-@a was undetectable . from baseline to @ months post-admission , mir-@-@p and mir-@ remained elevated in patients compared to controls ( adjusted p < @ ) , with no further change in levels between @ and @ months ; whereas mir-@b fell to control levels by @ months . baseline levels of mir-@ in the lowest tertile were significantly associated with readmission for heart failure ( log-rank p < @ ) . in combination with nt-probnp and lvef , mir-@ significantly improved risk stratification ( p < @ ) . our study identifies mir-@ as a novel candidate biomarker for post-acs prognosis beyond existing biomarkers of lvef and nt-probnp . moreover circulating mir-@-@p was markedly elevated in patients for at least a year post-acs and may be a stable biomarker for acs . | 25,124,998 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"prolonged ventilation and failed extubation are associated with increased harm and cost .",
"the added value of heart and respiratory rate variability ( hrv and rrv ) during spontaneous breathing trials ( sbts ) to predict extubation failure remains unknown .",
"we enrolled @ patients in a multicenter ( @ sites ) , prospective , observational study , evaluating clinical estimates of risk of extubation failure , physiologic measures recorded during sbts , hrv and rrv recorded before and during the last sbt prior to extubation , and extubation outcomes .",
"we excluded @ patients because of protocol or technical violations , or poor data quality .",
"measures of variability ( @ hrv , @ rrv ) were calculated from electrocardiogram and capnography waveforms followed by automated cleaning and variability analysis using continuous individualized multiorgan variability analysis ( cimva ) software .",
"repeated randomized subsampling with training , validation , and testing were used to derive and compare predictive models .",
"of @ patients with high-quality data , @ ( @ % ) failed extubation .",
"two hrv and eight rrv measures showed statistically significant association with extubation failure ( p < @ , @ % false discovery rate ) .",
"an ensemble average of five univariate logistic regression models using rrv during sbt , yielding a probability of extubation failure ( called wave score ) , demonstrated optimal predictive capacity .",
"with repeated random subsampling and testing , the model showed mean receiver operating characteristic area under the curve ( roc auc ) of @ , higher than heart rate ( @ ) , rapid shallow breathing index ( rbsi ; @ ) and respiratory rate ( @ ) .",
"after deriving a wave model based on all data , training-set performance demonstrated that the model increased its predictive power when applied to patients conventionally considered high risk : a wave score > @ in patients with rsbi > @ and perceived high risk of failure yielded a fold increase in risk of extubation failure of @ ( @ % confidence interval ( ci ) @ to @ ) and @ ( @ % ci @ to @ ) , respectively .",
"altered hrv and rrv ( during the sbt prior to extubation ) are significantly associated with extubation failure .",
"a predictive model using rrv during the last sbt provided optimal accuracy of prediction in all patients , with improved accuracy when combined with clinical impression or rsbi .",
"this model requires a validation cohort to evaluate accuracy and generalizability .",
"clinicaltrials.gov nct@ .",
"registered @ october @ ."
] | prolonged ventilation and failed extubation are associated with increased harm and cost . the added value of heart and respiratory rate variability ( hrv and rrv ) during spontaneous breathing trials ( sbts ) to predict extubation failure remains unknown . we enrolled @ patients in a multicenter ( @ sites ) , prospective , observational study , evaluating clinical estimates of risk of extubation failure , physiologic measures recorded during sbts , hrv and rrv recorded before and during the last sbt prior to extubation , and extubation outcomes . we excluded @ patients because of protocol or technical violations , or poor data quality . measures of variability ( @ hrv , @ rrv ) were calculated from electrocardiogram and capnography waveforms followed by automated cleaning and variability analysis using continuous individualized multiorgan variability analysis ( cimva ) software . repeated randomized subsampling with training , validation , and testing were used to derive and compare predictive models . of @ patients with high-quality data , @ ( @ % ) failed extubation . two hrv and eight rrv measures showed statistically significant association with extubation failure ( p < @ , @ % false discovery rate ) . an ensemble average of five univariate logistic regression models using rrv during sbt , yielding a probability of extubation failure ( called wave score ) , demonstrated optimal predictive capacity . with repeated random subsampling and testing , the model showed mean receiver operating characteristic area under the curve ( roc auc ) of @ , higher than heart rate ( @ ) , rapid shallow breathing index ( rbsi ; @ ) and respiratory rate ( @ ) . after deriving a wave model based on all data , training-set performance demonstrated that the model increased its predictive power when applied to patients conventionally considered high risk : a wave score > @ in patients with rsbi > @ and perceived high risk of failure yielded a fold increase in risk of extubation failure of @ ( @ % confidence interval ( ci ) @ to @ ) and @ ( @ % ci @ to @ ) , respectively . altered hrv and rrv ( during the sbt prior to extubation ) are significantly associated with extubation failure . a predictive model using rrv during the last sbt provided optimal accuracy of prediction in all patients , with improved accuracy when combined with clinical impression or rsbi . this model requires a validation cohort to evaluate accuracy and generalizability . clinicaltrials.gov nct@ . registered @ october @ . | 24,713,049 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"BACKGROUND",
"BACKGROUND"
] |
[
"electroencephalographic ( eeg ) status epilepticus is described in @ to @ % of patients with postanoxic encephalopathy after successful cardiopulmonary resuscitation and is associated with case fatality rates of @ to @ % .",
"it is unclear whether these eeg patterns represent a condition to be treated with anticonvulsants to improve outcome , or an expression of severe ischemic damage , in which treatment is futile .",
"telstar is a multicenter clinical trial with two parallel groups , randomized treatment allocation , open label treatment , and blinded endpoint evaluation ( probe design ) .",
"we aim to enroll @ adult patients with postanoxic encephalopathy and electroencephalographic status epilepticus after successful cardiopulmonary resuscitation , admitted to the icu , in whom continuous eeg monitoring is started within @ hours after admission .",
"patients are randomly assigned to either medical treatment to suppress all electrographic seizure activity , or no treatment of electroencephalographic status epilepticus .",
"antiepileptic treatment is based on guidelines for treatment of overt status epilepticus and is started within @ hours after the diagnosis .",
"if status epilepticus returns during tapering of sedative medication after suppression of all epileptiform activity for @ @ hours , it will be considered refractory .",
"the primary outcome measure is neurological outcome defined as the cerebral performance category ( cpc ) score at @ months , dichotomized into ` good ' ( cpc @ to @ = no or moderate neurological disability ) and ` poor ' ( cpc @ to @ = severe disability , coma , or death ) .",
"secondary outcome measures include mortality and , for patients surviving up to @ months , cognitive functioning , health related quality of life , and depression .",
"clinicaltrials.gov ; nct@ .",
"date of registration : @ february @ ."
] | electroencephalographic ( eeg ) status epilepticus is described in @ to @ % of patients with postanoxic encephalopathy after successful cardiopulmonary resuscitation and is associated with case fatality rates of @ to @ % . it is unclear whether these eeg patterns represent a condition to be treated with anticonvulsants to improve outcome , or an expression of severe ischemic damage , in which treatment is futile . telstar is a multicenter clinical trial with two parallel groups , randomized treatment allocation , open label treatment , and blinded endpoint evaluation ( probe design ) . we aim to enroll @ adult patients with postanoxic encephalopathy and electroencephalographic status epilepticus after successful cardiopulmonary resuscitation , admitted to the icu , in whom continuous eeg monitoring is started within @ hours after admission . patients are randomly assigned to either medical treatment to suppress all electrographic seizure activity , or no treatment of electroencephalographic status epilepticus . antiepileptic treatment is based on guidelines for treatment of overt status epilepticus and is started within @ hours after the diagnosis . if status epilepticus returns during tapering of sedative medication after suppression of all epileptiform activity for @ @ hours , it will be considered refractory . the primary outcome measure is neurological outcome defined as the cerebral performance category ( cpc ) score at @ months , dichotomized into ` good ' ( cpc @ to @ = no or moderate neurological disability ) and ` poor ' ( cpc @ to @ = severe disability , coma , or death ) . secondary outcome measures include mortality and , for patients surviving up to @ months , cognitive functioning , health related quality of life , and depression . clinicaltrials.gov ; nct@ . date of registration : @ february @ . | 25,377,067 | [
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"BACKGROUND",
"BACKGROUND"
] |
[
"the influence of variations in exercise mode , thermal state , and load carriage on cardiac and ventilatory predictors of metabolic rate were investigated .",
"fifteen males were studied at rest and during whole - , upper - , and lower-body exercise ( unloaded and loaded ) under thermoneutral and hot conditions .",
"ventilatory predictions were superior in thermoneutral ( residual mean square error range : @ to @ lmin ( -@ ) vs @ to @ lmin ( -@ ) ) and hot conditions ( @ to @ lmin ( -@ ) vs @ to @ lmin ( -@ ) ) .",
"predictions derived from whole - or lower-body exercise , and unloaded or loaded exercise could be interchanged without significant error .",
"nevertheless , a mode-specific prediction was required for upper-body work , and mild hyperthermia significantly reduced the precision of cardiac predictions .",
"ventilatory predictions were more precise , but errors from heart-rate predictions could be minimized by using thermal-state and exercise mode-specific predictions ."
] | the influence of variations in exercise mode , thermal state , and load carriage on cardiac and ventilatory predictors of metabolic rate were investigated . fifteen males were studied at rest and during whole - , upper - , and lower-body exercise ( unloaded and loaded ) under thermoneutral and hot conditions . ventilatory predictions were superior in thermoneutral ( residual mean square error range : @ to @ lmin ( -@ ) vs @ to @ lmin ( -@ ) ) and hot conditions ( @ to @ lmin ( -@ ) vs @ to @ lmin ( -@ ) ) . predictions derived from whole - or lower-body exercise , and unloaded or loaded exercise could be interchanged without significant error . nevertheless , a mode-specific prediction was required for upper-body work , and mild hyperthermia significantly reduced the precision of cardiac predictions . ventilatory predictions were more precise , but errors from heart-rate predictions could be minimized by using thermal-state and exercise mode-specific predictions . | 24,451,619 | [
"OBJECTIVE",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"long standing mitral valve disease is usually associated with severe pulmonary hypertension .",
"perioperative pulmonary hypertension is a risk factor for right ventricular ( rv ) failure and a cause for morbidity and mortality in patients undergoing mitral valve replacement .",
"phosphodiesterase @ inhibitor-sildenafil citrate is widely used to treat primary pulmonary hypertension .",
"there is a lack of evidence of effects of oral sildenafil on secondary pulmonary hypertension due to mitral valve disease .",
"the study aims to assess the effectiveness of preoperative oral sildenafil on severe pulmonary hypertension and incidence of rv failure in patients undergoing mitral valve replacement surgery .",
"a total of @ patients scheduled for mitral valve replacement with severe pulmonary hypertension ( rv systolic pressure ( rvsp ) @ mmhg ) on preoperative transthoracic echo were randomly treated with oral sildenafil @ mg ( n = @ ) or placebo ( n = @ ) eight hourly for @ h before surgery .",
"hemodynamic variables were measured @ min after insertion of pulmonary artery catheter ( pac ) under anesthesia ( t@ ) , @ min at weaning from cardiopulmonary bypass ( cpb ) ( t@ ) and after @,@ , and @ h ( t@ , t@ , t@ , respectively ) during the postoperative period .",
"systolic and mean pulmonary artery pressure ( mpap ) and pulmonary vascular resistance index ( pvri ) were significantly lower ( p < @ ) in sildenafil group at all times .",
"ventilation time and postoperative recovery room stay were significantly lower ( p < @ ) in sildenafil group .",
"sildenafil produces significant pulmonary vasodilatory effect as compared with placebo in mitral valve replacement patients with severe pulmonary hypertension .",
"it also reduces ventilation time and intensive care unit ( icu ) stay time as compared with placebo .",
"it is concluded that sildenafil is effective in reducing pulmonary hypertension when administered preoperatively in patients with severe pulmonary hypertension undergoing mitral valve replacement surgery ."
] | long standing mitral valve disease is usually associated with severe pulmonary hypertension . perioperative pulmonary hypertension is a risk factor for right ventricular ( rv ) failure and a cause for morbidity and mortality in patients undergoing mitral valve replacement . phosphodiesterase @ inhibitor-sildenafil citrate is widely used to treat primary pulmonary hypertension . there is a lack of evidence of effects of oral sildenafil on secondary pulmonary hypertension due to mitral valve disease . the study aims to assess the effectiveness of preoperative oral sildenafil on severe pulmonary hypertension and incidence of rv failure in patients undergoing mitral valve replacement surgery . a total of @ patients scheduled for mitral valve replacement with severe pulmonary hypertension ( rv systolic pressure ( rvsp ) @ mmhg ) on preoperative transthoracic echo were randomly treated with oral sildenafil @ mg ( n = @ ) or placebo ( n = @ ) eight hourly for @ h before surgery . hemodynamic variables were measured @ min after insertion of pulmonary artery catheter ( pac ) under anesthesia ( t@ ) , @ min at weaning from cardiopulmonary bypass ( cpb ) ( t@ ) and after @,@ , and @ h ( t@ , t@ , t@ , respectively ) during the postoperative period . systolic and mean pulmonary artery pressure ( mpap ) and pulmonary vascular resistance index ( pvri ) were significantly lower ( p < @ ) in sildenafil group at all times . ventilation time and postoperative recovery room stay were significantly lower ( p < @ ) in sildenafil group . sildenafil produces significant pulmonary vasodilatory effect as compared with placebo in mitral valve replacement patients with severe pulmonary hypertension . it also reduces ventilation time and intensive care unit ( icu ) stay time as compared with placebo . it is concluded that sildenafil is effective in reducing pulmonary hypertension when administered preoperatively in patients with severe pulmonary hypertension undergoing mitral valve replacement surgery . | 24,987,174 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"breech presentation occurs in up to @ % of pregnancies at term and may be an indication for caesarean delivery .",
"external cephalic version can be effective in repositioning the fetus in a cephalic presentation , but may be painful for the mother .",
"our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version .",
"a randomized , double-blind , controlled trial that included women at @-@ weeks of gestation with non-cephalic presentations was performed .",
"women were randomized to receive either a remifentanil infusion at @ g/kg/min and demand boluses of @ g/kg , or saline placebo .",
"the primary outcome was the numerical rating pain score ( @-@ ) after external cephalic version .",
"sixty women were recruited , @ in the control group and @ in the remifentanil group .",
"there were significant differences in pain scores at the end of the procedure ( control @ @ vs. remifentanil @ @ , p = @ ) but not @ min later ( p = @ ) .",
"the overall success rate for external cephalic version was @ % with no significant differences between groups ( remifentanil group @ % vs. control group @ % , p = @ ) .",
"in the remifentanil group , there was one case of nausea and vomiting , one of drowsiness and three cases of fetal bradycardia .",
"in the control group , there were three cases of nausea and vomiting , one of dizziness and nine cases of fetal bradycardia .",
"intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction .",
"there were no additional adverse effects , and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia ."
] | breech presentation occurs in up to @ % of pregnancies at term and may be an indication for caesarean delivery . external cephalic version can be effective in repositioning the fetus in a cephalic presentation , but may be painful for the mother . our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version . a randomized , double-blind , controlled trial that included women at @-@ weeks of gestation with non-cephalic presentations was performed . women were randomized to receive either a remifentanil infusion at @ g/kg/min and demand boluses of @ g/kg , or saline placebo . the primary outcome was the numerical rating pain score ( @-@ ) after external cephalic version . sixty women were recruited , @ in the control group and @ in the remifentanil group . there were significant differences in pain scores at the end of the procedure ( control @ @ vs. remifentanil @ @ , p = @ ) but not @ min later ( p = @ ) . the overall success rate for external cephalic version was @ % with no significant differences between groups ( remifentanil group @ % vs. control group @ % , p = @ ) . in the remifentanil group , there was one case of nausea and vomiting , one of drowsiness and three cases of fetal bradycardia . in the control group , there were three cases of nausea and vomiting , one of dizziness and nine cases of fetal bradycardia . intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction . there were no additional adverse effects , and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia . | 24,388,737 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"people with stroke excessively move their trunk , when reaching and grasping objects .",
"to determine if the addition of trunk restraint to modified constraint-induced movement therapy ( mcimt ) was better than mcimt alone in improving strength , function , and quality of life after stroke .",
"a pilot randomized double-blinded clinical trial was conducted .",
"twenty-two participants with chronic stroke were randomly assigned to an experimental group that received mcimt plus trunk restraint , or a control group ( only mcimt ) .",
"primary outcomes were the amount of use and quality of movement of the paretic upper limb ( ul ) , determined by the motor activity log ( mal ) scores .",
"secondary outcomes included the observed performance of the paretic ul during unimanual and bimanual tasks , kinematics of reaching , strength , and quality of life .",
"both groups demonstrated significant improvements in the mal scores and in the time to perform bimanual activities immediately after the interventions .",
"however , no between-group differences were observed .",
"the addition of trunk restraint to mcimt resulted in no additional benefits , compared with mcimt alone with stroke individuals with mild to moderate impairments .",
"unimanual and bimanual improvements were observed after mcimt , regardless of trunk restraint , and the intervention did not adversely affect their reaching patterns ."
] | people with stroke excessively move their trunk , when reaching and grasping objects . to determine if the addition of trunk restraint to modified constraint-induced movement therapy ( mcimt ) was better than mcimt alone in improving strength , function , and quality of life after stroke . a pilot randomized double-blinded clinical trial was conducted . twenty-two participants with chronic stroke were randomly assigned to an experimental group that received mcimt plus trunk restraint , or a control group ( only mcimt ) . primary outcomes were the amount of use and quality of movement of the paretic upper limb ( ul ) , determined by the motor activity log ( mal ) scores . secondary outcomes included the observed performance of the paretic ul during unimanual and bimanual tasks , kinematics of reaching , strength , and quality of life . both groups demonstrated significant improvements in the mal scores and in the time to perform bimanual activities immediately after the interventions . however , no between-group differences were observed . the addition of trunk restraint to mcimt resulted in no additional benefits , compared with mcimt alone with stroke individuals with mild to moderate impairments . unimanual and bimanual improvements were observed after mcimt , regardless of trunk restraint , and the intervention did not adversely affect their reaching patterns . | 25,227,543 | [
"BACKGROUND",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"theory-based interventions to promote physical activity ( pa ) are more effective than atheoretical approaches ; however , the comparative utility of theoretical models is rarely tested in longitudinal designs with multiple time points .",
"further , there is limited research that has simultaneously tested social-cognitive models with self-report and objective pa measures .",
"the primary aim of this study was to test the predictive ability of three theoretical models ( social cognitive theory , theory of planned behaviour , and protection motivation theory ) in explaining pa behaviour .",
"participants were adults with type @ diabetes ( n = @ , @ % males , mean age = @ @ years ) .",
"theoretical constructs across the three theories were tested to prospectively predict pa behaviour ( objective and self-report ) across three @-month time intervals ( baseline-@ , @-@ , @-@ months ) using structural equation modelling .",
"pa outcomes were steps/@ days ( objective ) and minutes of met-weighted pa/week ( self-report ) .",
"the mean proportion of variance in pa explained by these models was @ % for objective pa and @ % for self-report pa. .",
"direct pathways to pa outcomes were stronger for self-report compared with objective pa. .",
"these theories explained a small proportion of the variance in longitudinal pa studies .",
"theory development to guide interventions for increasing and maintaining pa in adults with type @ diabetes requires further research with objective measures .",
"theory integration across social-cognitive models and the inclusion of ecological levels are recommended to further explain pa behaviour change in this population .",
"statement of contribution what is already known on this subject ?",
"social-cognitive theories are able to explain partial variance for physical activity ( pa ) behaviour .",
"what does this study add ?",
"the testing of three theories in a longitudinal design over @ , @-month time intervals .",
"the parallel use and comparison of both objective and self-report pa measures in testing these theories ."
] | theory-based interventions to promote physical activity ( pa ) are more effective than atheoretical approaches ; however , the comparative utility of theoretical models is rarely tested in longitudinal designs with multiple time points . further , there is limited research that has simultaneously tested social-cognitive models with self-report and objective pa measures . the primary aim of this study was to test the predictive ability of three theoretical models ( social cognitive theory , theory of planned behaviour , and protection motivation theory ) in explaining pa behaviour . participants were adults with type @ diabetes ( n = @ , @ % males , mean age = @ @ years ) . theoretical constructs across the three theories were tested to prospectively predict pa behaviour ( objective and self-report ) across three @-month time intervals ( baseline-@ , @-@ , @-@ months ) using structural equation modelling . pa outcomes were steps/@ days ( objective ) and minutes of met-weighted pa/week ( self-report ) . the mean proportion of variance in pa explained by these models was @ % for objective pa and @ % for self-report pa. . direct pathways to pa outcomes were stronger for self-report compared with objective pa. . these theories explained a small proportion of the variance in longitudinal pa studies . theory development to guide interventions for increasing and maintaining pa in adults with type @ diabetes requires further research with objective measures . theory integration across social-cognitive models and the inclusion of ecological levels are recommended to further explain pa behaviour change in this population . statement of contribution what is already known on this subject ? social-cognitive theories are able to explain partial variance for physical activity ( pa ) behaviour . what does this study add ? the testing of three theories in a longitudinal design over @ , @-month time intervals . the parallel use and comparison of both objective and self-report pa measures in testing these theories . | 24,308,845 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"monitoring implementation of the `` test and treat '' case-management policy for malaria is an important component of all malaria control programmes in africa .",
"unfortunately , routine information systems are commonly deficient to provide necessary information .",
"using health facility surveys we monitored health systems readiness and malaria case-management practices prior to and following implementation of the @ `` test and treat '' policy in kenya .",
"between @ and @ six national , cross-sectional , health facility surveys were undertaken .",
"the number of facilities assessed ranged between @ and @ , health workers interviewed between @ and @ and outpatient consultations for febrile patients evaluated between @,@ and @,@ across six surveys .",
"comparing baseline and the last survey results , all readiness indicators showed significant ( p < @ ) improvements : availability of parasitological diagnosis ( @ % to @ % ) ; rdt availability ( @ % to @ % ) ; total artemether-lumefantrine ( al ) stock-out ( @ % to @ % ) ; stock-out of one or more al packs ( @ % to @ % ) ; training coverage ( @ to @ % ) ; guidelines access ( @ to @ % ) and supervision ( @ % to @ % ) .",
"testing increased by @ % ( @ % to @ % ; p < @ ) while testing and treatment according to test result increased by @ % ( @ % to @ % ; p < @ ) .",
"treatment adherence for test positive patients improved from @ % to @ % ( p = @ ) and for test negative patients from @ % to @ % ( p < @ ) .",
"significant testing and treatment improvements were observed in children and adults .",
"there was no difference in practices with respect to the type and result of malaria test ( rdt vs microscopy ) .",
"of eight dosing , dispensing and counseling tasks , improvements were observed for four tasks .",
"overall al use for febrile patients decreased from @ % to @ % ( p < @ ) .",
"major improvements in the implementation of `` test and treat '' policy were observed in kenya .",
"some gaps towards universal targets still remained .",
"other countries facing similar needs and challenges may consider health facility surveys to monitor malaria case-management ."
] | monitoring implementation of the `` test and treat '' case-management policy for malaria is an important component of all malaria control programmes in africa . unfortunately , routine information systems are commonly deficient to provide necessary information . using health facility surveys we monitored health systems readiness and malaria case-management practices prior to and following implementation of the @ `` test and treat '' policy in kenya . between @ and @ six national , cross-sectional , health facility surveys were undertaken . the number of facilities assessed ranged between @ and @ , health workers interviewed between @ and @ and outpatient consultations for febrile patients evaluated between @,@ and @,@ across six surveys . comparing baseline and the last survey results , all readiness indicators showed significant ( p < @ ) improvements : availability of parasitological diagnosis ( @ % to @ % ) ; rdt availability ( @ % to @ % ) ; total artemether-lumefantrine ( al ) stock-out ( @ % to @ % ) ; stock-out of one or more al packs ( @ % to @ % ) ; training coverage ( @ to @ % ) ; guidelines access ( @ to @ % ) and supervision ( @ % to @ % ) . testing increased by @ % ( @ % to @ % ; p < @ ) while testing and treatment according to test result increased by @ % ( @ % to @ % ; p < @ ) . treatment adherence for test positive patients improved from @ % to @ % ( p = @ ) and for test negative patients from @ % to @ % ( p < @ ) . significant testing and treatment improvements were observed in children and adults . there was no difference in practices with respect to the type and result of malaria test ( rdt vs microscopy ) . of eight dosing , dispensing and counseling tasks , improvements were observed for four tasks . overall al use for febrile patients decreased from @ % to @ % ( p < @ ) . major improvements in the implementation of `` test and treat '' policy were observed in kenya . some gaps towards universal targets still remained . other countries facing similar needs and challenges may consider health facility surveys to monitor malaria case-management . | 24,663,961 | [
"BACKGROUND",
"BACKGROUND",
"BACKGROUND",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"the aim of the study was to evaluate the effectiveness of intravenous iron versus placebo added to standard oral iron therapy in the treatment of severe postpartum anaemia .",
"a randomised , double-blind , parallel-group , placebo-controlled clinical trial was performed in a single centre .",
"hospital clinic of barcelona , barcelona , spain .",
"a cohort of @ women with severe postpartum anaemia ( @-@ @ g/dl ) treated with oral ferrous sulphate ( two tablets of @mg ) .",
"women were randomised to receive either intravenous ferrous sucrose ( @mg/@hours for two consecutive days ) or intravenous placebo , in addition to standard iron therapy .",
"clinical and laboratory data were obtained at @ , @ , and @weeks .",
"haemoglobin and haematocrit at @ , @ , and @weeks .",
"other haematological and clinical parameters , psychological status , and adverse side effects were also evaluated .",
"haemoglobin and haematocrit values were comparable in women receiving intravenous iron or placebo in addition to oral iron therapy at any of the time points .",
"at @weeks , haemoglobin level ( meansd ) was @ versus @ g/dl , with a mean difference of -@ ( @ % ci -@ to @ ) , in the placebo and in the intravenous iron groups , respectively .",
"no differences were found between clinical symptoms of anaemia , psychological status , and adverse side effects between groups .",
"intravenous iron added to oral iron therapy did not show significant benefits over placebo , neither in haemoglobin rise nor in symptoms or adverse side effects ."
] | the aim of the study was to evaluate the effectiveness of intravenous iron versus placebo added to standard oral iron therapy in the treatment of severe postpartum anaemia . a randomised , double-blind , parallel-group , placebo-controlled clinical trial was performed in a single centre . hospital clinic of barcelona , barcelona , spain . a cohort of @ women with severe postpartum anaemia ( @-@ @ g/dl ) treated with oral ferrous sulphate ( two tablets of @mg ) . women were randomised to receive either intravenous ferrous sucrose ( @mg/@hours for two consecutive days ) or intravenous placebo , in addition to standard iron therapy . clinical and laboratory data were obtained at @ , @ , and @weeks . haemoglobin and haematocrit at @ , @ , and @weeks . other haematological and clinical parameters , psychological status , and adverse side effects were also evaluated . haemoglobin and haematocrit values were comparable in women receiving intravenous iron or placebo in addition to oral iron therapy at any of the time points . at @weeks , haemoglobin level ( meansd ) was @ versus @ g/dl , with a mean difference of -@ ( @ % ci -@ to @ ) , in the placebo and in the intravenous iron groups , respectively . no differences were found between clinical symptoms of anaemia , psychological status , and adverse side effects between groups . intravenous iron added to oral iron therapy did not show significant benefits over placebo , neither in haemoglobin rise nor in symptoms or adverse side effects . | 24,423,186 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS"
] |
[
"evidence suggests a positive association between administration of psychoactive drugs and rates of cigarette smoking .",
"prevalence of smoking among opioid-dependent individuals , for example , is four times greater than the general population .",
"we recently completed a randomized double-blind trial evaluating outpatient buprenorphine taper for prescription opioid ( po ) abusers , which provided a unique opportunity to examine naturalistic changes in smoking among participants who detoxified without resumption of illicit opioid use .",
"participants received no smoking-cessation services and were not encouraged to alter their smoking in any way .",
"a subset of @ opioid-dependent smokers , who were randomized to receive the same @-week buprenorphine taper and successfully completed detoxification , were included in the present study .",
"they provided staff-observed urine specimens thrice-weekly throughout the @-week trial .",
"specimens were analyzed on-site via enzyme-multiplied immunoassay for urinary cotinine , a metabolite of nicotine that provides a sensitive biochemical measure of smoking status .",
"mean cotinine levels were significantly different across study phases , with significantly lower cotinine levels during taper ( @ ng/ml ) and post-taper ( @ ng/ml ) vs. intake ( @ ng/ml ) phases ( p '' s < @ ) .",
"overall , mean cotinine levels decreased by @ % between intake and end-of-study , reflecting a reduction of approximately eight cigarettes per day .",
"these data provide additional evidence that opioids influence smoking and extend prior findings to include primary po abusers , rigorous double-blind opioid dosing conditions and urinary cotinine .",
"these results also suggest that , while likely insufficient for complete cessation , patients who successfully taper from opioids may also experience concurrent reductions in smoking and thus may be ideal candidates for smoking cessation services ."
] | evidence suggests a positive association between administration of psychoactive drugs and rates of cigarette smoking . prevalence of smoking among opioid-dependent individuals , for example , is four times greater than the general population . we recently completed a randomized double-blind trial evaluating outpatient buprenorphine taper for prescription opioid ( po ) abusers , which provided a unique opportunity to examine naturalistic changes in smoking among participants who detoxified without resumption of illicit opioid use . participants received no smoking-cessation services and were not encouraged to alter their smoking in any way . a subset of @ opioid-dependent smokers , who were randomized to receive the same @-week buprenorphine taper and successfully completed detoxification , were included in the present study . they provided staff-observed urine specimens thrice-weekly throughout the @-week trial . specimens were analyzed on-site via enzyme-multiplied immunoassay for urinary cotinine , a metabolite of nicotine that provides a sensitive biochemical measure of smoking status . mean cotinine levels were significantly different across study phases , with significantly lower cotinine levels during taper ( @ ng/ml ) and post-taper ( @ ng/ml ) vs. intake ( @ ng/ml ) phases ( p '' s < @ ) . overall , mean cotinine levels decreased by @ % between intake and end-of-study , reflecting a reduction of approximately eight cigarettes per day . these data provide additional evidence that opioids influence smoking and extend prior findings to include primary po abusers , rigorous double-blind opioid dosing conditions and urinary cotinine . these results also suggest that , while likely insufficient for complete cessation , patients who successfully taper from opioids may also experience concurrent reductions in smoking and thus may be ideal candidates for smoking cessation services . | 24,845,165 | [
"OBJECTIVE",
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"we evaluated whether presenting prescription drug efficacy information in direct-to-consumer ( dtc ) advertising helps individuals accurately report a drug 's benefits and , if so , which numerical format is most helpful .",
"we conducted a randomized , controlled study of individuals diagnosed with high cholesterol ( n = @ ) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats .",
"we measured drug efficacy recall , drug perceptions and attitudes , behavioral intentions , and drug risk recall .",
"individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information .",
"participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats .",
"adding efficacy information to dtc ads-both in print and on television-may potentially increase an individual 's knowledge of a drug 's efficacy , which may improve patient-provider communication and promote more informed decisions .",
"providing quantitative efficacy information in a combination of formats ( e.g. , absolute frequency and percent ) may help patients remember information and make decisions about prescription drugs ."
] | we evaluated whether presenting prescription drug efficacy information in direct-to-consumer ( dtc ) advertising helps individuals accurately report a drug 's benefits and , if so , which numerical format is most helpful . we conducted a randomized , controlled study of individuals diagnosed with high cholesterol ( n = @ ) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats . we measured drug efficacy recall , drug perceptions and attitudes , behavioral intentions , and drug risk recall . individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information . participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats . adding efficacy information to dtc ads-both in print and on television-may potentially increase an individual 's knowledge of a drug 's efficacy , which may improve patient-provider communication and promote more informed decisions . providing quantitative efficacy information in a combination of formats ( e.g. , absolute frequency and percent ) may help patients remember information and make decisions about prescription drugs . | 24,581,929 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"the aim of the present study was to investigate the analgesic and anti-inflammatory effects of dexketoprofen trometamol ( dt ) and paracetamol on deep acute somatic pain and inflammation in patients undergoing impacted third molar surgery .",
"this study was planned to present benefits that we could obtain with low burden of drug .",
"effects of drugs , which were administered preemptively before the procedure , on pain , mouth-opening limitation , and swelling were assessed by visual analogue scale ( vas ) , magnetic resonance imaging ( mri ) , and mouth-opening measurement .",
"following surgery , time intervals when the patients first need to receive the drug were measured .",
"the vas scores of the patients were lower in the side treated with dt than that in the paracetamol treated side .",
"there was no significant difference between the groups in terms of mouth-opening limitation .",
"mri recordings revealed that swelling was lower in the side treated with paracetamol than dt treated side .",
"administration of the drugs before surgery contributed to the postoperative patient comfort .",
"the analgesic activity of @ mg dose of dt was similar to , even better than , the analgesic activity of @ mg dose of paracetamol ; however , dt had insufficient anti-inflammatory efficacy ."
] | the aim of the present study was to investigate the analgesic and anti-inflammatory effects of dexketoprofen trometamol ( dt ) and paracetamol on deep acute somatic pain and inflammation in patients undergoing impacted third molar surgery . this study was planned to present benefits that we could obtain with low burden of drug . effects of drugs , which were administered preemptively before the procedure , on pain , mouth-opening limitation , and swelling were assessed by visual analogue scale ( vas ) , magnetic resonance imaging ( mri ) , and mouth-opening measurement . following surgery , time intervals when the patients first need to receive the drug were measured . the vas scores of the patients were lower in the side treated with dt than that in the paracetamol treated side . there was no significant difference between the groups in terms of mouth-opening limitation . mri recordings revealed that swelling was lower in the side treated with paracetamol than dt treated side . administration of the drugs before surgery contributed to the postoperative patient comfort . the analgesic activity of @ mg dose of dt was similar to , even better than , the analgesic activity of @ mg dose of paracetamol ; however , dt had insufficient anti-inflammatory efficacy . | 25,129,247 | [
"OBJECTIVE",
"OBJECTIVE",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"this study aims to compare the effects of a lifestyle intervention using a behavioral therapy ( bt ) approach with the effects of a cardioprotective structured hypocaloric diet on metabolic syndrome in mexican postmenopausal women .",
"this study is a randomized clinical trial ( @-@ ) of mexican postmenopausal women with metabolic syndrome ( adult treatment panel iii criteria ) who were recruited from the postmenopause clinic of the national institute of perinatology in mexico city .",
"women were assigned to one of two groups -- group @ ( structured hypocaloric diet ; n = @ ) : energy restriction ( -@ to -@ kcal/d ) emphasizing cardioprotective dietary changes ; and group @ ( bt ; n = @ ) : goal setting , problem-solving , and stimulus control to achieve cardioprotective dietary and lifestyle recommendations .",
"metabolic syndrome prevalence , as well as weight , waist circumference , fat mass , and fasting biochemical markers ( glucose and lipid profile ) , were measured at baseline and at @ , @ , and @ months after the intervention .",
"metabolic syndrome risk ( relative risk and absolute risk reduction ) , mean differences between groups , and logistic regression were evaluated using statistical package for the social sciences software , version @ .",
"a total of @ women were studied ( mean -lsb- sd -rsb- age , @ -lsb- @ -rsb- y ) .",
"no baseline differences were observed between groups .",
"at the end of the study , a higher reduction in metabolic syndrome prevalence was observed in group @ ( -@ % ) compared with group @ ( -@ % ; relative risk , @ ; @ % ci , @-@ @ ; p = @ ) .",
"the effect was maintained even when adjusted by age , hormone therapy and antihypertensive drug use .",
"a cardioprotective structured hypocaloric diet is more effective than the bt approach in reducing metabolic syndrome after @ months of intervention .",
"both strategies have positive effects on different individual cardiovascular risk factors ."
] | this study aims to compare the effects of a lifestyle intervention using a behavioral therapy ( bt ) approach with the effects of a cardioprotective structured hypocaloric diet on metabolic syndrome in mexican postmenopausal women . this study is a randomized clinical trial ( @-@ ) of mexican postmenopausal women with metabolic syndrome ( adult treatment panel iii criteria ) who were recruited from the postmenopause clinic of the national institute of perinatology in mexico city . women were assigned to one of two groups -- group @ ( structured hypocaloric diet ; n = @ ) : energy restriction ( -@ to -@ kcal/d ) emphasizing cardioprotective dietary changes ; and group @ ( bt ; n = @ ) : goal setting , problem-solving , and stimulus control to achieve cardioprotective dietary and lifestyle recommendations . metabolic syndrome prevalence , as well as weight , waist circumference , fat mass , and fasting biochemical markers ( glucose and lipid profile ) , were measured at baseline and at @ , @ , and @ months after the intervention . metabolic syndrome risk ( relative risk and absolute risk reduction ) , mean differences between groups , and logistic regression were evaluated using statistical package for the social sciences software , version @ . a total of @ women were studied ( mean -lsb- sd -rsb- age , @ -lsb- @ -rsb- y ) . no baseline differences were observed between groups . at the end of the study , a higher reduction in metabolic syndrome prevalence was observed in group @ ( -@ % ) compared with group @ ( -@ % ; relative risk , @ ; @ % ci , @-@ @ ; p = @ ) . the effect was maintained even when adjusted by age , hormone therapy and antihypertensive drug use . a cardioprotective structured hypocaloric diet is more effective than the bt approach in reducing metabolic syndrome after @ months of intervention . both strategies have positive effects on different individual cardiovascular risk factors . | 24,378,762 | [
"OBJECTIVE",
"METHODS",
"METHODS",
"METHODS",
"METHODS",
"RESULTS",
"RESULTS",
"RESULTS",
"RESULTS",
"CONCLUSIONS",
"CONCLUSIONS"
] |
[
"randomized controlled trials ( rcts ) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies .",
"however , researchers conducting rcts commonly report difficulties in recruiting an adequate sample within planned timescales .",
"in an effort to overcome recruitment difficulties , researchers often are forced to expand their recruitment criteria or extend the recruitment phase , thus increasing costs and delaying publication of results .",
"research investigating the effectiveness of recruitment strategies is limited , and trials often fail to report sufficient details about the recruitment sources and resources utilized .",
"we examined the efficacy of strategies implemented during the staying well after depression rct in oxford to recruit participants with a history of recurrent depression .",
"we describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of ( @ ) the return , including the number of potential participants who contacted the trial and the number who were randomized into the trial ; ( @ ) cost-effectiveness , comprising direct financial cost and manpower for initial contacts and randomized participants ; and ( @ ) comparison of sociodemographic characteristics of individuals recruited from different sources .",
"poster advertising , web-based advertising , and mental health worker referrals were the cheapest methods per randomized participant ; however , the ratio of randomized participants to initial contacts differed markedly per source .",
"advertising online , via posters , and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial .",
"advertising across many sources ( saturation ) was found to be important .",
"it may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations , such as those currently unwell , or in other geographical locations .",
"recruitment source was unavailable for participants who could not be reached after the initial contact .",
"thus , it is possible that the efficiency of certain methods of recruitment was poorer than estimated .",
"efficacy and costs of other recruitment initiatives , such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly , were not analysed .",
"website advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting .",
"future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future rcts ."
] | randomized controlled trials ( rcts ) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies . however , researchers conducting rcts commonly report difficulties in recruiting an adequate sample within planned timescales . in an effort to overcome recruitment difficulties , researchers often are forced to expand their recruitment criteria or extend the recruitment phase , thus increasing costs and delaying publication of results . research investigating the effectiveness of recruitment strategies is limited , and trials often fail to report sufficient details about the recruitment sources and resources utilized . we examined the efficacy of strategies implemented during the staying well after depression rct in oxford to recruit participants with a history of recurrent depression . we describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of ( @ ) the return , including the number of potential participants who contacted the trial and the number who were randomized into the trial ; ( @ ) cost-effectiveness , comprising direct financial cost and manpower for initial contacts and randomized participants ; and ( @ ) comparison of sociodemographic characteristics of individuals recruited from different sources . poster advertising , web-based advertising , and mental health worker referrals were the cheapest methods per randomized participant ; however , the ratio of randomized participants to initial contacts differed markedly per source . advertising online , via posters , and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial . advertising across many sources ( saturation ) was found to be important . it may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations , such as those currently unwell , or in other geographical locations . recruitment source was unavailable for participants who could not be reached after the initial contact . thus , it is possible that the efficiency of certain methods of recruitment was poorer than estimated . efficacy and costs of other recruitment initiatives , such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly , were not analysed . website advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting . future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future rcts . | 24,686,105 | [
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[
"interventions promoting physical activity by general practitioners ( gps ) lack a strong evidence base .",
"recruiting participants to trials in primary care is challenging .",
"we investigated the feasibility of ( i ) delivering three interventions to promote physical activity in inactive participants and ( ii ) different methods of participant recruitment and randomised allocation .",
"we recruited general practices from devon , bristol and coventry .",
"we used a @-by-@ factorial design for participant recruitment and randomisation .",
"recruitment strategies were either opportunistic ( approaching patients attending their gp surgery ) or systematic ( selecting patients from practice lists and approaching them by letter ) .",
"randomisation strategies were either individual or by practice cluster .",
"feasibility outcomes included time taken to recruit the target number of participants within each practice .",
"participants were randomly allocated to one of three interventions : ( i ) written advice ( control ) ; ( ii ) brief gp advice ( written advice plus gp advice on physical activity ) , and ( iii ) brief gp advice plus a pedometer to self-monitor physical activity during the trial .",
"participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity , and were instructed not to unseal the pedometer before the scheduled day of data collection .",
"participant level outcomes were reported descriptively and included the mean number of pedometer steps over a @-day period , and european quality of life ( euroqol ) -@ dimensions ( eq-@d ) scores , recorded at @weeks ' follow-up .",
"we recruited @ practices ( @ using each recruitment method ; @ randomising by cluster , @ randomising by individual participant ) , encompassing @ participants .",
"opportunistic recruitment was associated with less time to target recruitment compared with systematic ( mean difference ( days ) -@ , @ % confidence interval ( ci ) -@ ; -@ ) but with greater loss to follow up ( @ % versus .",
"@ % ; mean difference @ % ( @ % ci @ % ; @ % ) ) .",
"there were differences in the socio-demographic characteristics of participants according to recruitment method .",
"there was no clear pattern of change in participant level outcomes from baseline to @weeks across the three arms .",
"delivering and trialling gp-led interventions to promote physical activity is feasible , but trial design influences time to participant recruitment , participant withdrawal , and possibly , the socio-demographic characteristics of participants .",
"isrctn@ ."
] | interventions promoting physical activity by general practitioners ( gps ) lack a strong evidence base . recruiting participants to trials in primary care is challenging . we investigated the feasibility of ( i ) delivering three interventions to promote physical activity in inactive participants and ( ii ) different methods of participant recruitment and randomised allocation . we recruited general practices from devon , bristol and coventry . we used a @-by-@ factorial design for participant recruitment and randomisation . recruitment strategies were either opportunistic ( approaching patients attending their gp surgery ) or systematic ( selecting patients from practice lists and approaching them by letter ) . randomisation strategies were either individual or by practice cluster . feasibility outcomes included time taken to recruit the target number of participants within each practice . participants were randomly allocated to one of three interventions : ( i ) written advice ( control ) ; ( ii ) brief gp advice ( written advice plus gp advice on physical activity ) , and ( iii ) brief gp advice plus a pedometer to self-monitor physical activity during the trial . participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity , and were instructed not to unseal the pedometer before the scheduled day of data collection . participant level outcomes were reported descriptively and included the mean number of pedometer steps over a @-day period , and european quality of life ( euroqol ) -@ dimensions ( eq-@d ) scores , recorded at @weeks ' follow-up . we recruited @ practices ( @ using each recruitment method ; @ randomising by cluster , @ randomising by individual participant ) , encompassing @ participants . opportunistic recruitment was associated with less time to target recruitment compared with systematic ( mean difference ( days ) -@ , @ % confidence interval ( ci ) -@ ; -@ ) but with greater loss to follow up ( @ % versus . @ % ; mean difference @ % ( @ % ci @ % ; @ % ) ) . there were differences in the socio-demographic characteristics of participants according to recruitment method . there was no clear pattern of change in participant level outcomes from baseline to @weeks across the three arms . delivering and trialling gp-led interventions to promote physical activity is feasible , but trial design influences time to participant recruitment , participant withdrawal , and possibly , the socio-demographic characteristics of participants . isrctn@ . | 24,746,263 | [
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] |
[
"in this study we tested the hypothesis that tirasemtiv , a selective fast skeletal muscle troponin activator that sensitizes the sarcomere to calcium , could amplify the response of muscle to neuromuscular input in humans .",
"healthy men received tirasemtiv and placebo in a randomized , double-blind , @-period , crossover design .",
"the deep fibular nerve was stimulated transcutaneously to activate the tibialis anterior muscle and produce dorsiflexion of the foot .",
"the force-frequency relationship of tibialis anterior dorsiflexion was assessed after dosing .",
"tirasemtiv increased force produced by the tibialis anterior in a dose - , concentration - , and frequency-dependent manner with the largest increases -lsb- up to @ % ( se @ ) , p < @ -rsb- produced at subtetanic nerve stimulation frequencies ( @ hz ) .",
"the data confirm that tirasemtiv amplifies the response of skeletal muscle to nerve input in humans .",
"this outcome provides support for further studies of tirasemtiv as a potential therapy in conditions marked by diminished neuromuscular input ."
] | in this study we tested the hypothesis that tirasemtiv , a selective fast skeletal muscle troponin activator that sensitizes the sarcomere to calcium , could amplify the response of muscle to neuromuscular input in humans . healthy men received tirasemtiv and placebo in a randomized , double-blind , @-period , crossover design . the deep fibular nerve was stimulated transcutaneously to activate the tibialis anterior muscle and produce dorsiflexion of the foot . the force-frequency relationship of tibialis anterior dorsiflexion was assessed after dosing . tirasemtiv increased force produced by the tibialis anterior in a dose - , concentration - , and frequency-dependent manner with the largest increases -lsb- up to @ % ( se @ ) , p < @ -rsb- produced at subtetanic nerve stimulation frequencies ( @ hz ) . the data confirm that tirasemtiv amplifies the response of skeletal muscle to nerve input in humans . this outcome provides support for further studies of tirasemtiv as a potential therapy in conditions marked by diminished neuromuscular input . | 24,634,285 | [
"BACKGROUND",
"METHODS",
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] |
[
"the present study addressed the ecological validity of the individual-focused experimental paradigm in sex research .",
"the aim of this study was to investigate the effect of partner presence vs. absence in the laboratory testing situation , and of manipulation of attentional focus , on genital and subjective sexual arousal of healthy women and men .",
"sexually functional heterosexual men ( n = @ ) and women ( n = @ ) and their partners participated in this study .",
"during partner presence , the partner sat opposite to the participant ; self-focused attention was experimentally manipulated by introducing , respectively , a semi-reflecting glass pane , and a wall-mounted camera .",
"perceived state self-focused attention and genital and subjective sexual arousal during presentation of audiovisual erotic film stimuli were assessed .",
"partner presence resulted in higher perceived self-focus ( ( p ) ( @ ) = @ ) and lower genital responses to erotic stimulation ( ( p ) ( @ ) = @ ) .",
"the interaction of partner presence and increased self-focused attention differentially affected genital arousal in female and male participants ( ( p ) ( @ ) = @ ) .",
"the mean genital response in men was lower during private self-focus than during non-self-focus with the partner present but was higher during private self-focus with the the partner absent ( ( p ) ( @ ) = @ ) .",
"the genital response in women to public self-focus was lower than to private self-focus and to non-self-focus with their partner present ( ( p ) ( @ ) = @ ) .",
"with the partner absent , the genital response in women to private self-focus was lower than to non-self-focus ( ( p ) ( @ ) = @ ) .",
"retrospective subjective arousal of women was higher with partner present ( m = @ ) than with partner absent ( m = @ ) , whereas men reported higher retrospective subjective arousal with their partner absent ( m = @ ) than present ( m = @ ) .",
"these findings suggest that mere presence of the partner impacts the sexual response differentially in women and men .",
"enhancing the ecological validity of the individual-based laboratory paradigm for sex research warrants closer examination in future research ."
] | the present study addressed the ecological validity of the individual-focused experimental paradigm in sex research . the aim of this study was to investigate the effect of partner presence vs. absence in the laboratory testing situation , and of manipulation of attentional focus , on genital and subjective sexual arousal of healthy women and men . sexually functional heterosexual men ( n = @ ) and women ( n = @ ) and their partners participated in this study . during partner presence , the partner sat opposite to the participant ; self-focused attention was experimentally manipulated by introducing , respectively , a semi-reflecting glass pane , and a wall-mounted camera . perceived state self-focused attention and genital and subjective sexual arousal during presentation of audiovisual erotic film stimuli were assessed . partner presence resulted in higher perceived self-focus ( ( p ) ( @ ) = @ ) and lower genital responses to erotic stimulation ( ( p ) ( @ ) = @ ) . the interaction of partner presence and increased self-focused attention differentially affected genital arousal in female and male participants ( ( p ) ( @ ) = @ ) . the mean genital response in men was lower during private self-focus than during non-self-focus with the partner present but was higher during private self-focus with the the partner absent ( ( p ) ( @ ) = @ ) . the genital response in women to public self-focus was lower than to private self-focus and to non-self-focus with their partner present ( ( p ) ( @ ) = @ ) . with the partner absent , the genital response in women to private self-focus was lower than to non-self-focus ( ( p ) ( @ ) = @ ) . retrospective subjective arousal of women was higher with partner present ( m = @ ) than with partner absent ( m = @ ) , whereas men reported higher retrospective subjective arousal with their partner absent ( m = @ ) than present ( m = @ ) . these findings suggest that mere presence of the partner impacts the sexual response differentially in women and men . enhancing the ecological validity of the individual-based laboratory paradigm for sex research warrants closer examination in future research . | 24,308,770 | [
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] |
[
"about one third of patients prescribed blood pressure or lipid-lowering drugs for the prevention of coronary heart disease and stroke do not take their medication as prescribed .",
"we conducted a randomized trial to evaluate text messaging as a means of improving adherence to cardiovascular disease preventive treatment .",
"@ patients taking blood pressure and/or lipid-lowering medications were randomly assigned to being sent text messages ( text group , @ ) or not being sent them ( no text group , @ ) .",
"texts were sent daily for @ weeks , alternate days for @ weeks and weekly thereafter for @ weeks ( @ months overall ) , using an automated computer programme .",
"patients were asked to respond on whether they had taken their medication , whether the text reminded them to do so if they had forgotten , and if they had not taken their medication to determine if there was a reason for not doing so .",
"at @ months , use of medication was assessed .",
"two patients were lost to follow-up , providing data on @ for analysis .",
"in the no text group @/@ ( @ % ) took less than @ % of the prescribed regimen ( ie .",
"stopped medication completely or took it on fewer than @ of the last @ days of follow-up ) compared to @/@ patients ( @ % ) in the text group - an improvement in adherence affecting @ per @ patients ( @ % ci @ to @ ) , p < @ .",
"the texts reminded @/@ patients ( @ % ) to take medication on at least one occasion and lead to @/@ ( @ % ) who stopped taking medication because of concern over efficacy or side-effects , resuming treatment .",
"in patients taking blood pressure or lipid-lowering treatment for the prevention of cardiovascular disease , text messaging improved medication adherence compared with no text messaging .",
"controlled-trials .",
"com isrctn@ ."
] | about one third of patients prescribed blood pressure or lipid-lowering drugs for the prevention of coronary heart disease and stroke do not take their medication as prescribed . we conducted a randomized trial to evaluate text messaging as a means of improving adherence to cardiovascular disease preventive treatment . @ patients taking blood pressure and/or lipid-lowering medications were randomly assigned to being sent text messages ( text group , @ ) or not being sent them ( no text group , @ ) . texts were sent daily for @ weeks , alternate days for @ weeks and weekly thereafter for @ weeks ( @ months overall ) , using an automated computer programme . patients were asked to respond on whether they had taken their medication , whether the text reminded them to do so if they had forgotten , and if they had not taken their medication to determine if there was a reason for not doing so . at @ months , use of medication was assessed . two patients were lost to follow-up , providing data on @ for analysis . in the no text group @/@ ( @ % ) took less than @ % of the prescribed regimen ( ie . stopped medication completely or took it on fewer than @ of the last @ days of follow-up ) compared to @/@ patients ( @ % ) in the text group - an improvement in adherence affecting @ per @ patients ( @ % ci @ to @ ) , p < @ . the texts reminded @/@ patients ( @ % ) to take medication on at least one occasion and lead to @/@ ( @ % ) who stopped taking medication because of concern over efficacy or side-effects , resuming treatment . in patients taking blood pressure or lipid-lowering treatment for the prevention of cardiovascular disease , text messaging improved medication adherence compared with no text messaging . controlled-trials . com isrctn@ . | 25,479,285 | [
"BACKGROUND",
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"METHODS",
"METHODS",
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] |
[
"a novel , fully bacterially produced recombinant virus-like particle ( vlp ) based influenza vaccine ( gh@-qbeta ) against a/california/@ / @ ( h@n@ ) was tested in a double-blind , randomized phase i clinical trial at two clinical sites in singapore .",
"the trial evaluated the immunogenicity and safety of gh@-qbeta in the presence or absence of alhydrogel adjuvant .",
"healthy adult volunteers with no or low pre-existing immunity against a/california/@ / @ ( h@n@ ) were randomized to receive two intramuscular injections @ days apart , with @g vaccine , containing @g hemagglutinin antigen .",
"antibody responses were measured before and @ days after each immunization by hemagglutination inhibition ( hai ) assays .",
"the primary endpoint was seroconversion on day @ , defined as percentage of subjects which reach a hai titer @ or achieve an at least @-fold rise in hai titer ( with pre-existing immunity ) .",
"the co-secondary endpoints were safety and seroconversion on day @ .",
"a total of @ asian volunteers were enrolled in this study and randomized to receive the adjuvanted ( n = @ ) or the non-adjuvanted ( n = @ ) vaccine .",
"of those , @ and @ respectively ( @ % ) completed the study .",
"there were no deaths or serious adverse events reported during this trial .",
"a total of @ adverse events occurred during treatment with @ % local solicited symptoms , of mostly ( @ % ) mild severity .",
"the most common treatment-related systemic symptom was fatigue .",
"the non-adjuvanted vaccine met all primary and secondary endpoints and showed seroconversion in @ % and @ % of participants respectively on day @ and day @ .",
"while the adjuvanted vaccine showed an increased seroconversion from @ % ( day @ ) to @ % ( day @ ) , it did not meet the immunogenicity endpoint .",
"in summary , non-adjuvanted gh@-qbeta showed similar antibody mediated immunogenicity and a comparable safety profile in healthy humans to commercially available vaccines .",
"these results warrant the consideration of this vlp vaccine platform for the vaccination against influenza infection ( hsa ctc@ ) ."
] | a novel , fully bacterially produced recombinant virus-like particle ( vlp ) based influenza vaccine ( gh@-qbeta ) against a/california/@ / @ ( h@n@ ) was tested in a double-blind , randomized phase i clinical trial at two clinical sites in singapore . the trial evaluated the immunogenicity and safety of gh@-qbeta in the presence or absence of alhydrogel adjuvant . healthy adult volunteers with no or low pre-existing immunity against a/california/@ / @ ( h@n@ ) were randomized to receive two intramuscular injections @ days apart , with @g vaccine , containing @g hemagglutinin antigen . antibody responses were measured before and @ days after each immunization by hemagglutination inhibition ( hai ) assays . the primary endpoint was seroconversion on day @ , defined as percentage of subjects which reach a hai titer @ or achieve an at least @-fold rise in hai titer ( with pre-existing immunity ) . the co-secondary endpoints were safety and seroconversion on day @ . a total of @ asian volunteers were enrolled in this study and randomized to receive the adjuvanted ( n = @ ) or the non-adjuvanted ( n = @ ) vaccine . of those , @ and @ respectively ( @ % ) completed the study . there were no deaths or serious adverse events reported during this trial . a total of @ adverse events occurred during treatment with @ % local solicited symptoms , of mostly ( @ % ) mild severity . the most common treatment-related systemic symptom was fatigue . the non-adjuvanted vaccine met all primary and secondary endpoints and showed seroconversion in @ % and @ % of participants respectively on day @ and day @ . while the adjuvanted vaccine showed an increased seroconversion from @ % ( day @ ) to @ % ( day @ ) , it did not meet the immunogenicity endpoint . in summary , non-adjuvanted gh@-qbeta showed similar antibody mediated immunogenicity and a comparable safety profile in healthy humans to commercially available vaccines . these results warrant the consideration of this vlp vaccine platform for the vaccination against influenza infection ( hsa ctc@ ) . | 25,045,806 | [
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] |