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[ "in children with single right ventricular ( rv ) anomalies , changes in rv size and function may beinfluenced by shunt type chosen at the time of the norwood procedure .", "the study sought to identify shunt-related differences in echocardiographic findings at @ months and@months pre-fontan in survivors of the norwood procedure .", "we compared @-dimensional and doppler echocardiographic indices of rv size and function , neo-aortic and tricuspid valve annulus dimensions and function , and aortic size and patency at @ @ months and @ @ months in subjects randomized to a norwood procedure using either the modified blalock-taussig shunt ( mbts ) or right ventricle to pulmonary artery shunt ( rvpas ) .", "acceptable echocardiograms were available at both time points in @ subjects ( @ mbts , @ rvpas ) .", "at @ months , all indices were similar between shunt groups .", "from the @-month to pre-fontan echocardiogram , the mbts group had stable indexed rv volumes and ejection fraction , while the rvpas group had increased rv end-systolic volume ( p = @ ) and decreased right ventricular ejection fraction ( rvef ) ( p = @ ) .", "from @ months to pre-fontan , the treatment groups were similar with respect to decline in indexed neo-aortic valve area , > mild neo-aortic valve regurgitation ( < @ % at each time ) , indexed tricuspid valve area , andmoderate tricuspid valve regurgitation ( < @ % at each time ) .", "initial norwood shunt type influences pre-fontan rv remodeling during the second and third years of life in survivors with single rv anomalies , with greater rvef deterioration after rvpas .", "encouragingly , other indices of rv function remain stable before fontan regardless of shunt type .", "( comparison of two types of shunts in infants with single ventricle defect undergoing staged reconstruction-pediatric heart network ; nct@ ) ." ]
in children with single right ventricular ( rv ) anomalies , changes in rv size and function may beinfluenced by shunt type chosen at the time of the norwood procedure . the study sought to identify shunt-related differences in echocardiographic findings at @ months and@months pre-fontan in survivors of the norwood procedure . we compared @-dimensional and doppler echocardiographic indices of rv size and function , neo-aortic and tricuspid valve annulus dimensions and function , and aortic size and patency at @ @ months and @ @ months in subjects randomized to a norwood procedure using either the modified blalock-taussig shunt ( mbts ) or right ventricle to pulmonary artery shunt ( rvpas ) . acceptable echocardiograms were available at both time points in @ subjects ( @ mbts , @ rvpas ) . at @ months , all indices were similar between shunt groups . from the @-month to pre-fontan echocardiogram , the mbts group had stable indexed rv volumes and ejection fraction , while the rvpas group had increased rv end-systolic volume ( p = @ ) and decreased right ventricular ejection fraction ( rvef ) ( p = @ ) . from @ months to pre-fontan , the treatment groups were similar with respect to decline in indexed neo-aortic valve area , > mild neo-aortic valve regurgitation ( < @ % at each time ) , indexed tricuspid valve area , andmoderate tricuspid valve regurgitation ( < @ % at each time ) . initial norwood shunt type influences pre-fontan rv remodeling during the second and third years of life in survivors with single rv anomalies , with greater rvef deterioration after rvpas . encouragingly , other indices of rv function remain stable before fontan regardless of shunt type . ( comparison of two types of shunts in infants with single ventricle defect undergoing staged reconstruction-pediatric heart network ; nct@ ) .
25,440,099
[ "BACKGROUND", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of the study was to compare cistiquer , a new phytotherapeutic product developed for chronic bladder inflammatory diseases , and intra-vesical administration of gentamicin plus betametasone , in females with urethral syndrome .", "between september @ and may @ , @ women with urethral syndrome and trigonitis were incuded in this study .", "patients were randomly assigned to treatment with intra-vesical administration of betametasone @ mg plus gentamicin @ mg ( group a ) , and oral administration of cistiquer ( group b ) for @ weeks .", "before and after the therapeutic protocol , symptoms were assessed by three days voiding diary , the overactive bladder questionnaire short form and a ten points visual analogic scale adopted to assess the micturition discomfort .", "histologic findings were assessed by the examination of specimens obtained by cold bladder biopsies of the bladder trigone at baseline in all the subjects .", "the two groups had significant and comparable symptoms improvement .", "however , the score obtained from the visual analogic scale decreased significantly only in the group submitted to oral therapy .", "furthermore , in the group treated with endovesical approach , higher drop out rate and higher incidence of urinary infection were observed .", "patients with urethral syndrome and trigonitis improved symptoms either with oral therapy with cistiquer and with intra-vesical administration of gentamicin plus betametasone .", "however , treatment adherence resulted higher for patients treated by oral therapy and rate of adverse events resulted higher for those submitted to endovesical treatment ." ]
the aim of the study was to compare cistiquer , a new phytotherapeutic product developed for chronic bladder inflammatory diseases , and intra-vesical administration of gentamicin plus betametasone , in females with urethral syndrome . between september @ and may @ , @ women with urethral syndrome and trigonitis were incuded in this study . patients were randomly assigned to treatment with intra-vesical administration of betametasone @ mg plus gentamicin @ mg ( group a ) , and oral administration of cistiquer ( group b ) for @ weeks . before and after the therapeutic protocol , symptoms were assessed by three days voiding diary , the overactive bladder questionnaire short form and a ten points visual analogic scale adopted to assess the micturition discomfort . histologic findings were assessed by the examination of specimens obtained by cold bladder biopsies of the bladder trigone at baseline in all the subjects . the two groups had significant and comparable symptoms improvement . however , the score obtained from the visual analogic scale decreased significantly only in the group submitted to oral therapy . furthermore , in the group treated with endovesical approach , higher drop out rate and higher incidence of urinary infection were observed . patients with urethral syndrome and trigonitis improved symptoms either with oral therapy with cistiquer and with intra-vesical administration of gentamicin plus betametasone . however , treatment adherence resulted higher for patients treated by oral therapy and rate of adverse events resulted higher for those submitted to endovesical treatment .
25,034,330
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the cardiorespiratory , sedative and antinociceptive effects of dexmedetomidine alone or in combination with methadone , morphine or tramadol in dogs .", "experimental , blinded , randomized , crossover study .", "six mixed breed dogs ( two males and four females ) weighing @ @ kg .", "the animals were randomly divided into four treatments : d ( @ g kg ( -@ ) of dexmedetomidine ) , dm ( dexmedetomidine @ g kg ( -@ ) and methadone @ mg kg ( -@ ) ) ; dmo ( dexmedetomidine @ g kg ( -@ ) and morphine @ mg kg ( -@ ) ) , and dt ( dexmedetomidine @ g kg ( -@ ) and tramadol @ mg kg ( -@ ) ) .", "the combinations were administered intramuscularly in all treatments .", "the variables evaluated were heart rate ( hr ) , respiratory rate ( f ( r ) ) , rectal temperature ( rt ) , systolic arterial pressure ( sap ) , sedation scale and pedal withdrawal reflex .", "these variables were measured at t@ ( immediately before the administration of the protocol ) and every @ minutes thereafter until t@ .", "a decrease in hr and f ( r ) occurred in all the treatments compared with t@ , but no significant difference was observed between the treatments .", "the rt decreased from t@ onward in all the treatments .", "the sap did not show a difference between the treatments , but in the dt treatment , the sap was lower at t@ and t@ compared with t@ .", "the d treatment had lower scores of sedation at t@ to t@ compared with the other treatments , and the dmo and dm treatments showed higher scores at t@ and t@ compared with dt .", "the treatments with morphine and methadone added to the dexmedetomidine showed higher sedation scores than the control treatment and the treatment with tramadol added to the dexmedetomidine showed no relevant differences in any of the variables evaluated in the study ." ]
to evaluate the cardiorespiratory , sedative and antinociceptive effects of dexmedetomidine alone or in combination with methadone , morphine or tramadol in dogs . experimental , blinded , randomized , crossover study . six mixed breed dogs ( two males and four females ) weighing @ @ kg . the animals were randomly divided into four treatments : d ( @ g kg ( -@ ) of dexmedetomidine ) , dm ( dexmedetomidine @ g kg ( -@ ) and methadone @ mg kg ( -@ ) ) ; dmo ( dexmedetomidine @ g kg ( -@ ) and morphine @ mg kg ( -@ ) ) , and dt ( dexmedetomidine @ g kg ( -@ ) and tramadol @ mg kg ( -@ ) ) . the combinations were administered intramuscularly in all treatments . the variables evaluated were heart rate ( hr ) , respiratory rate ( f ( r ) ) , rectal temperature ( rt ) , systolic arterial pressure ( sap ) , sedation scale and pedal withdrawal reflex . these variables were measured at t@ ( immediately before the administration of the protocol ) and every @ minutes thereafter until t@ . a decrease in hr and f ( r ) occurred in all the treatments compared with t@ , but no significant difference was observed between the treatments . the rt decreased from t@ onward in all the treatments . the sap did not show a difference between the treatments , but in the dt treatment , the sap was lower at t@ and t@ compared with t@ . the d treatment had lower scores of sedation at t@ to t@ compared with the other treatments , and the dmo and dm treatments showed higher scores at t@ and t@ compared with dt . the treatments with morphine and methadone added to the dexmedetomidine showed higher sedation scores than the control treatment and the treatment with tramadol added to the dexmedetomidine showed no relevant differences in any of the variables evaluated in the study .
24,962,038
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this study was conducted to examine the effects of aerobic exercise training on psychosocial aspects ( mental health , the aspects of physical symptoms , anxiety and insomnia , social functioning , and depression ) in patients with type @ diabetes mellitus .", "@ men who had type @ diabetes mellitus for a mean duration of the disease for @ years were selected purposely and classified randomly into experimental ( @ patients ) and a control group ( @ patients ) .", "patients in the experimental group did aerobic exercise training three times a week for eight weeks .", "the exercise included an aerobic activity for @ to @ minutes during which the patients ' heart rates were maintained at @-@ percent of heart rate reserve on ergo meter bikes .", "the eight-week aerobic exercise training had significant effects on mental health ( p = @ ) , subscales of physical symptoms ( p = @ ) , and anxiety and insomnia ( p = @ ) .", "it had no significant effects on subscales related to disorder of social functioning ( p = @ ) and depression ( p = @ ) .", "aerobic exercise training can be considered as an appropriate program for improving the health of the patients with type @ diabetes mellitus , and it also can improve their mental health ." ]
this study was conducted to examine the effects of aerobic exercise training on psychosocial aspects ( mental health , the aspects of physical symptoms , anxiety and insomnia , social functioning , and depression ) in patients with type @ diabetes mellitus . @ men who had type @ diabetes mellitus for a mean duration of the disease for @ years were selected purposely and classified randomly into experimental ( @ patients ) and a control group ( @ patients ) . patients in the experimental group did aerobic exercise training three times a week for eight weeks . the exercise included an aerobic activity for @ to @ minutes during which the patients ' heart rates were maintained at @-@ percent of heart rate reserve on ergo meter bikes . the eight-week aerobic exercise training had significant effects on mental health ( p = @ ) , subscales of physical symptoms ( p = @ ) , and anxiety and insomnia ( p = @ ) . it had no significant effects on subscales related to disorder of social functioning ( p = @ ) and depression ( p = @ ) . aerobic exercise training can be considered as an appropriate program for improving the health of the patients with type @ diabetes mellitus , and it also can improve their mental health .
24,576,381
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the whitehall ii ( whii ) study of british civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing .", "this paper introduces the multi-modal magnetic resonance imaging ( mri ) protocol and cognitive assessment designed to investigate brain health in a random sample of @ members of the whii study .", "a total of @ civil servants participated in the whii phase @ clinical examination in @-@ .", "a random sample of these participants was included in a sub-study comprising an mri brain scan , a detailed clinical and cognitive assessment , and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures .", "data collection for this sub-study started in @ and will be completed by @ .", "the participants , for whom social and health records have been collected since @ , were between @-@ years of age at the time the mri study started .", "here , we describe the pre-specified clinical and cognitive assessment protocols , the state-of-the-art mri sequences and latest pipelines for analyses of this sub-study .", "the integration of cutting-edge mri techniques , clinical and cognitive tests in combination with retrospective data on social , behavioural and biological variables during the preceding @years from a well-established longitudinal epidemiological study ( whii cohort ) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes ." ]
the whitehall ii ( whii ) study of british civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing . this paper introduces the multi-modal magnetic resonance imaging ( mri ) protocol and cognitive assessment designed to investigate brain health in a random sample of @ members of the whii study . a total of @ civil servants participated in the whii phase @ clinical examination in @-@ . a random sample of these participants was included in a sub-study comprising an mri brain scan , a detailed clinical and cognitive assessment , and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures . data collection for this sub-study started in @ and will be completed by @ . the participants , for whom social and health records have been collected since @ , were between @-@ years of age at the time the mri study started . here , we describe the pre-specified clinical and cognitive assessment protocols , the state-of-the-art mri sequences and latest pipelines for analyses of this sub-study . the integration of cutting-edge mri techniques , clinical and cognitive tests in combination with retrospective data on social , behavioural and biological variables during the preceding @years from a well-established longitudinal epidemiological study ( whii cohort ) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes .
24,885,374
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]
[ "results from the national lung cancer audit demonstrate unexplained variation in outcomes .", "peer review with supported quality improvement has been shown to reduce variation in other areas of health care but has not been formally tested in cancer multidisciplinary teams .", "the aim of the current study is to assess the impact of reciprocal peer-to-peer review visits with supported quality improvement and collaborative working on lung cancer process and outcome measures .", "english lung cancer teams were randomised to usual care or facilitated reciprocal peer review visits followed by @ months of supported quality improvement .", "the primary outcome was change in the following national audit indicators ; mulitdisciplinary team discussion , histological confirmation , active treatment , surgical resection , small-cell chemotherapy and specialist nurse review .", "patient experience was measured using a new lung cancer patient questionnaire in the intervention group .", "thirty teams ( @ trusts ) entered the intervention group and @ of these submitted a total of @ quality improvement plans .", "active treatment increased in the intervention group ( n = @ ) by @ % compared with @ % in the control group ( n = @ , mean difference @ % , @ % ci -@ to @ % , p = @ ) .", "the remaining audit indicators improved similarly in all groups .", "mean patient experience scores in the intervention group did not change significantly during the study but a significant improvement was seen in the scores for the five teams with the worst baseline scores ( @ to @ , p < @ ) .", "reciprocal peer review with supported quality improvement was feasible and effective in stimulating quality improvement activity but resulted in only modest improvements in lung cancer treatment rates and patient experience ." ]
results from the national lung cancer audit demonstrate unexplained variation in outcomes . peer review with supported quality improvement has been shown to reduce variation in other areas of health care but has not been formally tested in cancer multidisciplinary teams . the aim of the current study is to assess the impact of reciprocal peer-to-peer review visits with supported quality improvement and collaborative working on lung cancer process and outcome measures . english lung cancer teams were randomised to usual care or facilitated reciprocal peer review visits followed by @ months of supported quality improvement . the primary outcome was change in the following national audit indicators ; mulitdisciplinary team discussion , histological confirmation , active treatment , surgical resection , small-cell chemotherapy and specialist nurse review . patient experience was measured using a new lung cancer patient questionnaire in the intervention group . thirty teams ( @ trusts ) entered the intervention group and @ of these submitted a total of @ quality improvement plans . active treatment increased in the intervention group ( n = @ ) by @ % compared with @ % in the control group ( n = @ , mean difference @ % , @ % ci -@ to @ % , p = @ ) . the remaining audit indicators improved similarly in all groups . mean patient experience scores in the intervention group did not change significantly during the study but a significant improvement was seen in the scores for the five teams with the worst baseline scores ( @ to @ , p < @ ) . reciprocal peer review with supported quality improvement was feasible and effective in stimulating quality improvement activity but resulted in only modest improvements in lung cancer treatment rates and patient experience .
24,651,386
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "chronic fatigue syndrome or myalgic encephalomyelitis ( cfs/me ) is a relatively common and potentially serious condition with a limited evidence base for treatment .", "specialist treatment for paediatric cfs/me uses interventions recommended by national institute for health and clinical excellence ( nice ) including cognitive behavioural therapy , graded exercise therapy and activity management .", "the lightning process ( lp ) is a trademarked intervention derived from osteopathy , life-coaching and neuro-linguistic programming , delivered over three consecutive days as group sessions .", "although over @ children with cfs/me attend lp courses each year , there are no reported studies on the effectiveness or cost-effectiveness .", "this pragmatic randomised controlled trial is set within a specialist paediatric cfs/me service in the south west of england .", "children and young people with cfs/me ( n = @ to @ ) , aged @ to @ years old will be randomised to specialist medical care ( smc ) or smc plus the lp .", "the primary outcome will be physical function ( sf-@ physical function short form ) and fatigue ( chalder fatigue scale ) .", "this study will tell us whether adding the lp to smc is effective and cost-effective compared to smc alone .", "this study will also provide detailed information on the implementation of the lp and smc .", "current controlled trials isrctn@ ( @ july @ ) ." ]
chronic fatigue syndrome or myalgic encephalomyelitis ( cfs/me ) is a relatively common and potentially serious condition with a limited evidence base for treatment . specialist treatment for paediatric cfs/me uses interventions recommended by national institute for health and clinical excellence ( nice ) including cognitive behavioural therapy , graded exercise therapy and activity management . the lightning process ( lp ) is a trademarked intervention derived from osteopathy , life-coaching and neuro-linguistic programming , delivered over three consecutive days as group sessions . although over @ children with cfs/me attend lp courses each year , there are no reported studies on the effectiveness or cost-effectiveness . this pragmatic randomised controlled trial is set within a specialist paediatric cfs/me service in the south west of england . children and young people with cfs/me ( n = @ to @ ) , aged @ to @ years old will be randomised to specialist medical care ( smc ) or smc plus the lp . the primary outcome will be physical function ( sf-@ physical function short form ) and fatigue ( chalder fatigue scale ) . this study will tell us whether adding the lp to smc is effective and cost-effective compared to smc alone . this study will also provide detailed information on the implementation of the lp and smc . current controlled trials isrctn@ ( @ july @ ) .
24,370,208
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the study was designed to evaluate the effectiveness of the combination of chemonucleolysis and psoas compartment block ( pcb ) for the treatment of lumbar disc herniations ( ldhs ) and to explore the role of pcb in managing postoperative pain of collagenase injection .", "two groups of patients ( n = @ ) were treated in different ways , respectively .", "group a ( n = @ ) was treated with chemonucleolysis only ( the injection of oxygen-ozone combined with collagenase into the lumbar disc and the epidural space ) ; group b ( n = @ ) was treated with chemonucleolysis and pcb .", "after the treatment , the patients were followed-up , and the therapeutic effect was assessed at @ week , @ month , @ months , and @ months by the relative pain reduction , visual analog scale ( vas ) pain scores , and the oswestry disability index ( odi ) scores .", "in group a , treatment success rate was @ % ( @ of @ ) , @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) at @ week , @ month , @ months , and @ months , respectively .", "in group b , treatment success rate was @ % ( @ of @ ) , @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) at @ week , @ month , @ months , and @ months , respectively .", "there was statistically significant difference in outcome between two groups at @ week , but there were no statistically significant difference in outcome between two groups at @ month , @ months , and @ months .", "vas scores and odi were significantly decreased in both group a and group b , when compared with the baseline values in the same group at all points of follow-up .", "group b produced a significant reduction in the vas scores and odi when compared with group a at : @-week , @-month , @-month , @-month follow-up .", "computer tomography ( ct ) - guided chemonucleolysis combined with pcb leads to rapid pain relief , fewer postoperative pain of collagenase injection happen , and should be regarded as a useful treatment for the management of ldh ." ]
the study was designed to evaluate the effectiveness of the combination of chemonucleolysis and psoas compartment block ( pcb ) for the treatment of lumbar disc herniations ( ldhs ) and to explore the role of pcb in managing postoperative pain of collagenase injection . two groups of patients ( n = @ ) were treated in different ways , respectively . group a ( n = @ ) was treated with chemonucleolysis only ( the injection of oxygen-ozone combined with collagenase into the lumbar disc and the epidural space ) ; group b ( n = @ ) was treated with chemonucleolysis and pcb . after the treatment , the patients were followed-up , and the therapeutic effect was assessed at @ week , @ month , @ months , and @ months by the relative pain reduction , visual analog scale ( vas ) pain scores , and the oswestry disability index ( odi ) scores . in group a , treatment success rate was @ % ( @ of @ ) , @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) at @ week , @ month , @ months , and @ months , respectively . in group b , treatment success rate was @ % ( @ of @ ) , @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) at @ week , @ month , @ months , and @ months , respectively . there was statistically significant difference in outcome between two groups at @ week , but there were no statistically significant difference in outcome between two groups at @ month , @ months , and @ months . vas scores and odi were significantly decreased in both group a and group b , when compared with the baseline values in the same group at all points of follow-up . group b produced a significant reduction in the vas scores and odi when compared with group a at : @-week , @-month , @-month , @-month follow-up . computer tomography ( ct ) - guided chemonucleolysis combined with pcb leads to rapid pain relief , fewer postoperative pain of collagenase injection happen , and should be regarded as a useful treatment for the management of ldh .
25,041,326
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults .", "secondary analysis of data from a randomized controlled trial .", "an @,@-bed general hospital in england providing the only emergency medical services in its area .", "cognitively impaired individuals aged @ and older randomly assigned to a specialist unit or standard geriatric or internal medical wards ( n = @ ) and related caregivers ( n = @ ) .", "patient and caregiver health status was measured at baseline , including delirium , cognitive impairment , behavioral and psychological symptoms , activities of daily living , and caregiver strain .", "caregiver satisfaction with quality of care was ascertained after hospital discharge or death .", "four hundred sixty-two caregivers completed satisfaction questionnaires .", "regardless of assignment , @ % of caregivers were dissatisfied with some aspects of care , but overall @ % were satisfied with care .", "the main areas of dissatisfaction were communication , discharge planning , and medical management .", "dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission , caregiver strain and poor psychological well-being at admission , a diagnosis of delirium , and the relationship between the caregiver and the patient .", "there was less dissatisfaction from caregivers of patients managed on the specialist medical and mental health unit than those on standard wards , after controlling for multiple factors .", "dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care ." ]
to identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults . secondary analysis of data from a randomized controlled trial . an @,@-bed general hospital in england providing the only emergency medical services in its area . cognitively impaired individuals aged @ and older randomly assigned to a specialist unit or standard geriatric or internal medical wards ( n = @ ) and related caregivers ( n = @ ) . patient and caregiver health status was measured at baseline , including delirium , cognitive impairment , behavioral and psychological symptoms , activities of daily living , and caregiver strain . caregiver satisfaction with quality of care was ascertained after hospital discharge or death . four hundred sixty-two caregivers completed satisfaction questionnaires . regardless of assignment , @ % of caregivers were dissatisfied with some aspects of care , but overall @ % were satisfied with care . the main areas of dissatisfaction were communication , discharge planning , and medical management . dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission , caregiver strain and poor psychological well-being at admission , a diagnosis of delirium , and the relationship between the caregiver and the patient . there was less dissatisfaction from caregivers of patients managed on the specialist medical and mental health unit than those on standard wards , after controlling for multiple factors . dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care .
25,516,022
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "statins , or @-hydroxy-@-methylglutaryl coenzyme a ( hmg-coa ) reductase inhibitors , have anti-inflammatory effects that are independent of their lipid-lowering properties .", "despite suppressive antiretroviral therapy ( art ) , elevated levels of immune activation and inflammation often persist .", "the stopping atherosclerosis and treating unhealthy bone with rosuvastatin in hiv ( saturn-hiv ) trial is a randomized , double-blind , placebo-controlled study , designed to investigate the effects of rosuvastatin ( @ mg/daily ) on markers of cardiovascular disease risk in art-treated human immunodeficiency virus ( hiv ) - infected subjects .", "a preplanned analysis was to assess changes in markers of immune activation at week @ .", "subjects with low-density lipoprotein cholesterol < @ mg/dl and heightened immune activation ( % cd@ ( + ) cd@ ( + ) hla-dr ( + ) @ % , or plasma high-sensitivity c-reactive protein @ mg/l ) were randomized to receive rosuvastatin or placebo .", "we measured plasma ( soluble cd@ and cd@ ) and cellular markers of monocyte activation ( proportions of monocyte subsets and tissue factor expression ) and t-cell activation ( expression of cd@ , hla-dr , and pd@ ) .", "after @ weeks of rosuvastatin , we found significant decreases in plasma levels of soluble cd@ ( -@ % vs @ % , p = @ ) and in proportions of tissue factor-positive patrolling ( cd@ ( dim ) cd@ ( + ) ) monocytes ( -@ % vs -@ % , p = @ ) in rosuvastatin-treated vs placebo-treated subjects .", "these findings were independent of the lipid-lowering effect and the use of protease inhibitors .", "rosuvastatin did not lead to any changes in levels of t-cell activation .", "rosuvastatin treatment effectively lowered markers of monocyte activation in hiv-infected subjects on antiretroviral therapy .", "nct@ ." ]
statins , or @-hydroxy-@-methylglutaryl coenzyme a ( hmg-coa ) reductase inhibitors , have anti-inflammatory effects that are independent of their lipid-lowering properties . despite suppressive antiretroviral therapy ( art ) , elevated levels of immune activation and inflammation often persist . the stopping atherosclerosis and treating unhealthy bone with rosuvastatin in hiv ( saturn-hiv ) trial is a randomized , double-blind , placebo-controlled study , designed to investigate the effects of rosuvastatin ( @ mg/daily ) on markers of cardiovascular disease risk in art-treated human immunodeficiency virus ( hiv ) - infected subjects . a preplanned analysis was to assess changes in markers of immune activation at week @ . subjects with low-density lipoprotein cholesterol < @ mg/dl and heightened immune activation ( % cd@ ( + ) cd@ ( + ) hla-dr ( + ) @ % , or plasma high-sensitivity c-reactive protein @ mg/l ) were randomized to receive rosuvastatin or placebo . we measured plasma ( soluble cd@ and cd@ ) and cellular markers of monocyte activation ( proportions of monocyte subsets and tissue factor expression ) and t-cell activation ( expression of cd@ , hla-dr , and pd@ ) . after @ weeks of rosuvastatin , we found significant decreases in plasma levels of soluble cd@ ( -@ % vs @ % , p = @ ) and in proportions of tissue factor-positive patrolling ( cd@ ( dim ) cd@ ( + ) ) monocytes ( -@ % vs -@ % , p = @ ) in rosuvastatin-treated vs placebo-treated subjects . these findings were independent of the lipid-lowering effect and the use of protease inhibitors . rosuvastatin did not lead to any changes in levels of t-cell activation . rosuvastatin treatment effectively lowered markers of monocyte activation in hiv-infected subjects on antiretroviral therapy . nct@ .
24,253,250
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to compare the efficacy of an anhydrous dentifrice containing @ % w/w stannous fluoride and a negative control dentifrice containing @,@ ppm fluoride , as sodium monofluorophosphate , at reducing dentin hypersensitivity over @ weeks with twice-daily brushing .", "this was a randomized , examiner-blind , parallel , two treatment group , stratified ( by maximum baseline schiff sensitivity score ) , @-week clinical study carried out at a single site in @ healthy subjects with at least two sensitive teeth , who met all study criteria at the screening and baseline visits .", "clinical assessments of sensitivity to evaporative ( air ) -lsb- with schiff sensitivity score and visual analogue scale ( vas ) -rsb- and tactile ( yeaple probe ) stimuli were employed to compare the efficacy of the test dentifrice containing @ % w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after @ and @ weeks treatment .", "of the @ subjects randomized to study treatment , @ completed the study .", "at @ and @ weeks , between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures ( schiff : p < @ at @ and @ weeks ; vas score : p = @ at @ weeks , p < @ at @ weeks ; tactile threshold : p = @ at @ weeks , p < @ at @ weeks ) ." ]
to compare the efficacy of an anhydrous dentifrice containing @ % w/w stannous fluoride and a negative control dentifrice containing @,@ ppm fluoride , as sodium monofluorophosphate , at reducing dentin hypersensitivity over @ weeks with twice-daily brushing . this was a randomized , examiner-blind , parallel , two treatment group , stratified ( by maximum baseline schiff sensitivity score ) , @-week clinical study carried out at a single site in @ healthy subjects with at least two sensitive teeth , who met all study criteria at the screening and baseline visits . clinical assessments of sensitivity to evaporative ( air ) -lsb- with schiff sensitivity score and visual analogue scale ( vas ) -rsb- and tactile ( yeaple probe ) stimuli were employed to compare the efficacy of the test dentifrice containing @ % w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after @ and @ weeks treatment . of the @ subjects randomized to study treatment , @ completed the study . at @ and @ weeks , between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures ( schiff : p < @ at @ and @ weeks ; vas score : p = @ at @ weeks , p < @ at @ weeks ; tactile threshold : p = @ at @ weeks , p < @ at @ weeks ) .
26,437,498
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS" ]
[ "to discuss the influence of mifepristone to caspase @ expression in adenomyosis tissue .", "sixty patients were equally divided into four groups .", "groups @ , @ , and @ were treated with @ , @ , and @ mg mifepristone , respectively and group @ was treated with placebo .", "the expression of caspase @ was examined by immunohistochemical method in both eutopic and ectopic endometria of the @ cases .", "compared with placebo group , the expression of caspase @ in both eutopic endometrium and ectopic endometrium in the three treatment groups was significantly increased .", "there was no difference in the expression of caspase @ in both eutopic and ectopic endometria between the ten and @ mg treatment groups , while both the ten and @ mg treatment groups had a higher expression intensity of caspase @ in both eutopic and ectopic endometria , compared with the five mg treatment group ( p < @ ) .", "mifepristone can increase the expression of caspase @ in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria .", "therefore mifepristone can effectively inhibit the emergence and development of adenomyosis ." ]
to discuss the influence of mifepristone to caspase @ expression in adenomyosis tissue . sixty patients were equally divided into four groups . groups @ , @ , and @ were treated with @ , @ , and @ mg mifepristone , respectively and group @ was treated with placebo . the expression of caspase @ was examined by immunohistochemical method in both eutopic and ectopic endometria of the @ cases . compared with placebo group , the expression of caspase @ in both eutopic endometrium and ectopic endometrium in the three treatment groups was significantly increased . there was no difference in the expression of caspase @ in both eutopic and ectopic endometria between the ten and @ mg treatment groups , while both the ten and @ mg treatment groups had a higher expression intensity of caspase @ in both eutopic and ectopic endometria , compared with the five mg treatment group ( p < @ ) . mifepristone can increase the expression of caspase @ in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria . therefore mifepristone can effectively inhibit the emergence and development of adenomyosis .
24,779,241
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab , a monoclonal antibody against vascular endothelial growth factor , in patients with human immunodeficiency virus ( hiv ) - associated kaposi 's sarcoma of the upper airway receiving antiretroviral therapy .", "a pilot randomized , open , phase ii study .", "hiv-infected patients with kaposi 's sarcoma lesions of the upper airway in the t@ stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab .", "the primary end point was the assessment of changes in tumor size according to the response evaluation criteria in solid tumors ( recist ) ; the secondary end point was safety .", "of the @ patients with kaposi 's sarcoma included in the study , seven were assigned to the bevacizumab group and seven to the control group .", "the median age was @ years ( interquartile range -lsb- iqr -rsb- , @-@ @ ) .", "four patients ( @ % ) had > @ cd@ t cells/mm ( @ ) .", "nine patients had lesions in the oral cavity ; three patients had pharyngeal disease ; one patient had laryngeal involvement ; and one patient had oral cavity , pharyngeal , and laryngeal involvement .", "four patients had complete response ( @ % ) , two had partial response , six had stable disease , and two had progressive disease .", "the median time to complete response was @ weeks ( iqr , @-@ @ ) .", "no statistical differences between groups were observed ( p = @ ) .", "in the bevacizumab group , one patient had a grade i adverse event , and another patient had a grade ii adverse event .", "intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract kaposi 's sarcoma lesions of hiv-infected patients ." ]
the aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab , a monoclonal antibody against vascular endothelial growth factor , in patients with human immunodeficiency virus ( hiv ) - associated kaposi 's sarcoma of the upper airway receiving antiretroviral therapy . a pilot randomized , open , phase ii study . hiv-infected patients with kaposi 's sarcoma lesions of the upper airway in the t@ stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab . the primary end point was the assessment of changes in tumor size according to the response evaluation criteria in solid tumors ( recist ) ; the secondary end point was safety . of the @ patients with kaposi 's sarcoma included in the study , seven were assigned to the bevacizumab group and seven to the control group . the median age was @ years ( interquartile range -lsb- iqr -rsb- , @-@ @ ) . four patients ( @ % ) had > @ cd@ t cells/mm ( @ ) . nine patients had lesions in the oral cavity ; three patients had pharyngeal disease ; one patient had laryngeal involvement ; and one patient had oral cavity , pharyngeal , and laryngeal involvement . four patients had complete response ( @ % ) , two had partial response , six had stable disease , and two had progressive disease . the median time to complete response was @ weeks ( iqr , @-@ @ ) . no statistical differences between groups were observed ( p = @ ) . in the bevacizumab group , one patient had a grade i adverse event , and another patient had a grade ii adverse event . intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract kaposi 's sarcoma lesions of hiv-infected patients .
25,345,840
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "u.s. state aids drug assistance programs ( adaps ) are federally funded to provide antiretroviral therapy ( art ) as the payer of last resort to eligible persons with hiv infection .", "states differ regarding their financial contributions to and ways of implementing these programs , and it remains unclear how this interstate variability affects hiv treatment outcomes .", "we analyzed data from hiv-infected individuals who were clinically-eligible for art between @ and @ ( i.e. , a first reported cd@ + < @ cells/ul or aids-defining illness ) from @ u.s. cohorts of the north american aids cohort collaboration on research and design ( na-accord ) .", "using propensity score matching and cox regression , we assessed art initiation ( within @ months following eligibility ) and virologic suppression ( within @ year ) based on differences in two state adap features : the amount of state funding in annual adap budgets and the implementation of waiting lists .", "we performed an a priori subgroup analysis in persons with a history of injection drug use ( idu ) .", "among @,@ persons , @ % initiated art within six months following eligibility .", "persons living in states with no additional state contribution to the adap budget initiated art on a less timely basis ( hazard ratio -lsb- hr -rsb- @ , @ % ci @-@ @ ) .", "living in a state with an adap waiting list was not associated with less timely initiation ( hr @ , @ % ci @-@ @ ) .", "neither additional state contributions nor waiting lists were significantly associated with virologic suppression .", "persons with an idu history initiated art on a less timely basis ( hr @ , @ % ci @-@ @ ) .", "we found that living in states that did not contribute additionally to the adap budget was associated with delayed art initiation when treatment was clinically indicated .", "given the changing healthcare environment , continued assessment of the role of adaps and their features that facilitate prompt treatment is needed ." ]
u.s. state aids drug assistance programs ( adaps ) are federally funded to provide antiretroviral therapy ( art ) as the payer of last resort to eligible persons with hiv infection . states differ regarding their financial contributions to and ways of implementing these programs , and it remains unclear how this interstate variability affects hiv treatment outcomes . we analyzed data from hiv-infected individuals who were clinically-eligible for art between @ and @ ( i.e. , a first reported cd@ + < @ cells/ul or aids-defining illness ) from @ u.s. cohorts of the north american aids cohort collaboration on research and design ( na-accord ) . using propensity score matching and cox regression , we assessed art initiation ( within @ months following eligibility ) and virologic suppression ( within @ year ) based on differences in two state adap features : the amount of state funding in annual adap budgets and the implementation of waiting lists . we performed an a priori subgroup analysis in persons with a history of injection drug use ( idu ) . among @,@ persons , @ % initiated art within six months following eligibility . persons living in states with no additional state contribution to the adap budget initiated art on a less timely basis ( hazard ratio -lsb- hr -rsb- @ , @ % ci @-@ @ ) . living in a state with an adap waiting list was not associated with less timely initiation ( hr @ , @ % ci @-@ @ ) . neither additional state contributions nor waiting lists were significantly associated with virologic suppression . persons with an idu history initiated art on a less timely basis ( hr @ , @ % ci @-@ @ ) . we found that living in states that did not contribute additionally to the adap budget was associated with delayed art initiation when treatment was clinically indicated . given the changing healthcare environment , continued assessment of the role of adaps and their features that facilitate prompt treatment is needed .
24,260,137
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at @ months , but data regarding outcomes at @ months are currently lacking .", "we compared functional and quality-of-life outcomes at @ months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the interventional management of stroke iii trial .", "the key outcome measures were a modified rankin scale score @ ( functional independence ) and the euro-qol eq-@d , a health-related quality-of-life measure .", "@ subjects with moderate-to-severe stroke ( national institutes of health stroke scale @ ) were enrolled at @ centers in the united states ( @ sites ) , canada ( @ ) , australia ( @ ) , and europe ( @ ) .", "there was an interaction between treatment group and stroke severity in the repeated measures analysis of modified rankin scale @ outcome ( p = @ ) .", "in the @ participants with severe stroke ( national institutes of health stroke scale @ ) , a greater proportion of the endovascular group had a modified rankin scale @ ( @ % ) at @ months as compared with the intravenous tissue-type plasminogen activator group ( @ % , p = @ ) ; no difference was seen for the @ participants with moderately severe strokes ( @ % versus @ % ) .", "in participants with severe stroke , the endovascular group had @ ( @ % confidence interval : @ , @ ) more quality-adjusted-days over @ months as compared with intravenous tissue-type plasminogen activator alone .", "endovascular therapy improves functional outcome and health-related quality-of-life at @ months after severe ischemic stroke .", "url : http://www.clinicaltrials.gov .", "unique identifier : nct@ ." ]
randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at @ months , but data regarding outcomes at @ months are currently lacking . we compared functional and quality-of-life outcomes at @ months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the interventional management of stroke iii trial . the key outcome measures were a modified rankin scale score @ ( functional independence ) and the euro-qol eq-@d , a health-related quality-of-life measure . @ subjects with moderate-to-severe stroke ( national institutes of health stroke scale @ ) were enrolled at @ centers in the united states ( @ sites ) , canada ( @ ) , australia ( @ ) , and europe ( @ ) . there was an interaction between treatment group and stroke severity in the repeated measures analysis of modified rankin scale @ outcome ( p = @ ) . in the @ participants with severe stroke ( national institutes of health stroke scale @ ) , a greater proportion of the endovascular group had a modified rankin scale @ ( @ % ) at @ months as compared with the intravenous tissue-type plasminogen activator group ( @ % , p = @ ) ; no difference was seen for the @ participants with moderately severe strokes ( @ % versus @ % ) . in participants with severe stroke , the endovascular group had @ ( @ % confidence interval : @ , @ ) more quality-adjusted-days over @ months as compared with intravenous tissue-type plasminogen activator alone . endovascular therapy improves functional outcome and health-related quality-of-life at @ months after severe ischemic stroke . url : http://www.clinicaltrials.gov . unique identifier : nct@ .
25,858,239
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "in a recent double-blinded clinical trial , the probiotic combination of lactobacillus acidophilus ncfm ( l-ncfm ) and b-lbi@ reduced bloating symptoms in patients with functional bowel disorders ; an effect more evident in those who reported abdominal pain .", "in mice , l-ncfm but not b-lbi@ induced colonic mu-opioid receptor ( mor ) and cannabinoid receptor @ ( cb@ ) expression , and reduced visceral sensitivity .", "to determine if l-ncfm was the active component in the clinical trial and to investigate the mechanism of action in humans with mild to moderate abdominal pain .", "caucasian women ( n = @ ) @-@ years with mild to moderate abdominal pain were enrolled in a double-blind , two-armed , single-centre study .", "patients were given either l-ncfm alone or in combination with b-lbi@ for @ days at a total dose of @ @ ( @ ) cfu b.d. colonic biopsies were collected during unsedated , unprepped flexible sigmoidoscopy before and at the end of probiotic consumption .", "mrna and immunostaining were then performed on these biopsies .", "patients kept symptom diaries for the @ days prior to starting probiotic therapy and for the last @ days of therapy .", "l-ncfm alone , but not with b-lbi@ , induced colonic mor mrna and protein expression , as well as downstream signalling , as measured by enterocyte stat@-phosphorylation .", "in contrast , cb@ expression was decreased .", "both treatment groups trended towards improvement in symptoms , but the study was insufficiently powered to draw meaningful conclusions .", "lactobacillus acidophilus ncfm modulates mu-opioid receptor expression and activity , while the combination of l-ncfm and b-lbi@ does not .", "this study provides a possible mechanism for action by which probiotics modulates pain sensation in humans ( clinical trial number : nct@ ) ." ]
in a recent double-blinded clinical trial , the probiotic combination of lactobacillus acidophilus ncfm ( l-ncfm ) and b-lbi@ reduced bloating symptoms in patients with functional bowel disorders ; an effect more evident in those who reported abdominal pain . in mice , l-ncfm but not b-lbi@ induced colonic mu-opioid receptor ( mor ) and cannabinoid receptor @ ( cb@ ) expression , and reduced visceral sensitivity . to determine if l-ncfm was the active component in the clinical trial and to investigate the mechanism of action in humans with mild to moderate abdominal pain . caucasian women ( n = @ ) @-@ years with mild to moderate abdominal pain were enrolled in a double-blind , two-armed , single-centre study . patients were given either l-ncfm alone or in combination with b-lbi@ for @ days at a total dose of @ @ ( @ ) cfu b.d. colonic biopsies were collected during unsedated , unprepped flexible sigmoidoscopy before and at the end of probiotic consumption . mrna and immunostaining were then performed on these biopsies . patients kept symptom diaries for the @ days prior to starting probiotic therapy and for the last @ days of therapy . l-ncfm alone , but not with b-lbi@ , induced colonic mor mrna and protein expression , as well as downstream signalling , as measured by enterocyte stat@-phosphorylation . in contrast , cb@ expression was decreased . both treatment groups trended towards improvement in symptoms , but the study was insufficiently powered to draw meaningful conclusions . lactobacillus acidophilus ncfm modulates mu-opioid receptor expression and activity , while the combination of l-ncfm and b-lbi@ does not . this study provides a possible mechanism for action by which probiotics modulates pain sensation in humans ( clinical trial number : nct@ ) .
24,853,043
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "in guinea-bissau we conducted three trials of neonatal vitamin a supplementation ( nvas ) from @ to @ .", "none of the trials found a beneficial effect on mortality .", "from @ to @ , an early measles vaccine ( mv ) trial was ongoing , randomizing children @:@ to early mv at @ months or no early mv , in addition to the usual mv at @ months .", "we have previously found interactions between vitamin a and vaccines .", "we investigated whether there were interactions between nvas and early mv .", "we compared the mortality of nvas and placebo recipients : first , from @ to @ months for children randomized to early mv or no early mv ; and second , from @ to @ months in children who had received two mv or one mv .", "mortality rates ( mr ) were compared in cox models producing mortality rate ratios ( mrr ) .", "a total of @ children were randomized to nvas ( n = @ ) or placebo ( n = @ ) and were later randomized to early mv ( n = @ ) or no early mv ( n = @ ) .", "between @ and @ months , nvas compared with placebo was associated with higher mortality in early mv recipients ( mr = @ versus mr = @ , p = @ ) , but not in children who did not receive early mv ( p for interaction between nvas and early mv = @ ) .", "from @ to @ months nvas was not associated with mortality .", "overall , from @ to @ months nvas was associated with increased mortality in early mv recipients ( mortality rate ratio = @ ( @ % confidence interval : @ , @ ) ) .", "these observations indicate that nvas may interact with vaccines given several months later .", "this may have implications for the planning of future child intervention programs ." ]
in guinea-bissau we conducted three trials of neonatal vitamin a supplementation ( nvas ) from @ to @ . none of the trials found a beneficial effect on mortality . from @ to @ , an early measles vaccine ( mv ) trial was ongoing , randomizing children @:@ to early mv at @ months or no early mv , in addition to the usual mv at @ months . we have previously found interactions between vitamin a and vaccines . we investigated whether there were interactions between nvas and early mv . we compared the mortality of nvas and placebo recipients : first , from @ to @ months for children randomized to early mv or no early mv ; and second , from @ to @ months in children who had received two mv or one mv . mortality rates ( mr ) were compared in cox models producing mortality rate ratios ( mrr ) . a total of @ children were randomized to nvas ( n = @ ) or placebo ( n = @ ) and were later randomized to early mv ( n = @ ) or no early mv ( n = @ ) . between @ and @ months , nvas compared with placebo was associated with higher mortality in early mv recipients ( mr = @ versus mr = @ , p = @ ) , but not in children who did not receive early mv ( p for interaction between nvas and early mv = @ ) . from @ to @ months nvas was not associated with mortality . overall , from @ to @ months nvas was associated with increased mortality in early mv recipients ( mortality rate ratio = @ ( @ % confidence interval : @ , @ ) ) . these observations indicate that nvas may interact with vaccines given several months later . this may have implications for the planning of future child intervention programs .
25,131,735
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the efficacy and safety of adjunctive eslicarbazepine acetate ( esl ) in patients with refractory partial-onset seizures .", "this randomized , placebo-controlled , double-blind , parallel-group , phase iii study was conducted at @ centers in @ countries , including the united states and canada .", "eligible patients were aged @ years and had uncontrolled partial-onset seizures despite treatment with @-@ antiepileptic drugs ( aeds ) .", "after an @-week baseline period , patients were randomized to once-daily placebo ( n = @ ) , esl @ mg ( n = @ ) , or esl @,@ mg ( n = @ ) .", "following a @-week titration period , patients received esl @ or @,@ mg once-daily for @ weeks .", "seizure data were captured and documented using event-entry or daily entry diaries .", "standardized seizure frequency ( ssf ) during the maintenance period ( primary end point ) was reduced with esl @,@ mg ( p = @ ) , and there was a trend toward improvement with esl @ mg ( p = @ ) , compared with placebo .", "when data for titration and maintenance periods were combined , esl @ mg ( p = @ ) and @,@ mg ( p < @ ) both reduced ssf .", "there were no statistically significant interactions between treatment response and geographical region ( p = @ ) or diary version ( p = @ ) .", "responder rate ( @ % reduction in ssf ) was significantly higher with esl @,@ mg ( @ % , p < @ ) but not esl @ mg ( @ % , p = @ ) than placebo ( @ % ) .", "incidence of treatment-emergent adverse events ( teaes ) and teaes leading to discontinuation increased with esl dose .", "the most common teaes were dizziness , somnolence , nausea , headache , and diplopia .", "adjunctive esl @,@ mg once-daily was more efficacious than placebo in adult patients with refractory partial-onset seizures .", "the once-daily @ mg dose showed a marginal effect on ssf , but did not reach statistical significance .", "both doses were well tolerated .", "efficacy assessment was not affected by diary format used ." ]
to evaluate the efficacy and safety of adjunctive eslicarbazepine acetate ( esl ) in patients with refractory partial-onset seizures . this randomized , placebo-controlled , double-blind , parallel-group , phase iii study was conducted at @ centers in @ countries , including the united states and canada . eligible patients were aged @ years and had uncontrolled partial-onset seizures despite treatment with @-@ antiepileptic drugs ( aeds ) . after an @-week baseline period , patients were randomized to once-daily placebo ( n = @ ) , esl @ mg ( n = @ ) , or esl @,@ mg ( n = @ ) . following a @-week titration period , patients received esl @ or @,@ mg once-daily for @ weeks . seizure data were captured and documented using event-entry or daily entry diaries . standardized seizure frequency ( ssf ) during the maintenance period ( primary end point ) was reduced with esl @,@ mg ( p = @ ) , and there was a trend toward improvement with esl @ mg ( p = @ ) , compared with placebo . when data for titration and maintenance periods were combined , esl @ mg ( p = @ ) and @,@ mg ( p < @ ) both reduced ssf . there were no statistically significant interactions between treatment response and geographical region ( p = @ ) or diary version ( p = @ ) . responder rate ( @ % reduction in ssf ) was significantly higher with esl @,@ mg ( @ % , p < @ ) but not esl @ mg ( @ % , p = @ ) than placebo ( @ % ) . incidence of treatment-emergent adverse events ( teaes ) and teaes leading to discontinuation increased with esl dose . the most common teaes were dizziness , somnolence , nausea , headache , and diplopia . adjunctive esl @,@ mg once-daily was more efficacious than placebo in adult patients with refractory partial-onset seizures . the once-daily @ mg dose showed a marginal effect on ssf , but did not reach statistical significance . both doses were well tolerated . efficacy assessment was not affected by diary format used .
25,528,898
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine whether the use of narrow-band imaging ( nbi ) system could enhance the detection rate of esophageal squamous cell carcinoma and precancerous lesions during endoscopic examination of the esophagus .", "@ patients were randomized to undergo endoscopic examination using high definition television ( hdtv ) narrow band imaging ( nbi ) endoscopy or hdtv wl endoscopy .", "the primary endpoint was the difference in the neoplasm miss rate , and secondary outcome was the neoplasm detection rate .", "the number of esophageal cancer and high grade intraepithelial neoplasia lesions detected by hd-nbi and hd-wl was @ and @ , respectively .", "the neoplasm miss rate per lesion and per patient with hd-nbi showed significant difference compared with that of hd-wl ( p < @ ) .", "characteristics of lesions missed by use of hd-nbi were similar to those missed by use of hd-wl ; all missed lesions were high grade intraepithelial neoplasia lesions .", "significant difference was observed between nbi and wl in adenoma detection rate ( @ % vs. @ % , p < @ ) .", "endoscopy with hd-nbi seems to improve the detection of esophageal cancer and precancerous lesions , high definition may be tested for its effect on detection of esophageal cancer and precancerous lesions in the future .", "these results indicate that endoscopy routinely using the nbi system for the surveillance of esophageal cancer and precancerous lesions may be recommended ." ]
to determine whether the use of narrow-band imaging ( nbi ) system could enhance the detection rate of esophageal squamous cell carcinoma and precancerous lesions during endoscopic examination of the esophagus . @ patients were randomized to undergo endoscopic examination using high definition television ( hdtv ) narrow band imaging ( nbi ) endoscopy or hdtv wl endoscopy . the primary endpoint was the difference in the neoplasm miss rate , and secondary outcome was the neoplasm detection rate . the number of esophageal cancer and high grade intraepithelial neoplasia lesions detected by hd-nbi and hd-wl was @ and @ , respectively . the neoplasm miss rate per lesion and per patient with hd-nbi showed significant difference compared with that of hd-wl ( p < @ ) . characteristics of lesions missed by use of hd-nbi were similar to those missed by use of hd-wl ; all missed lesions were high grade intraepithelial neoplasia lesions . significant difference was observed between nbi and wl in adenoma detection rate ( @ % vs. @ % , p < @ ) . endoscopy with hd-nbi seems to improve the detection of esophageal cancer and precancerous lesions , high definition may be tested for its effect on detection of esophageal cancer and precancerous lesions in the future . these results indicate that endoscopy routinely using the nbi system for the surveillance of esophageal cancer and precancerous lesions may be recommended .
24,895,806
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this single-center , prospective , randomized , double-blind , @-arm , parallel group comparison trial was performed to establish whether the adult-sized laryngeal mask airway ( lma ) classic ( the laryngeal mask company ltd , henley-on-thames , uk ) could be used safely without any consideration of cuff hyperinflation when a cuff of the lma classic was inflated using half the maximum inflation volume or the resting volume before insertion of device .", "eighty patients aged @ to @ years scheduled for general anesthesia using the lma classic were included .", "before insertion , the cuff was partially filled with half the maximum inflation volume in the half volume group or the resting volume created by opening the pilot balloon valve to equalize with atmospheric pressure in the resting volume group .", "several parameters regarding insertion , intracuff pressure , airway leak pressure , and leakage volume/fraction were collected after lma insertion .", "the lma classic with a partially inflated cuff was successfully inserted in all enrolled patients .", "both groups had the same success rate of @ % at the first insertion attempt .", "the half volume group had a lower mean intracuff pressure compared with the resting volume group ( @ @ cm h@o vs @ @ cm h@o ; p = @ ) .", "there was no difference in airway leak pressure or leakage volume/fraction between the @ groups under mechanical ventilation .", "the partially inflated cuff method using half the maximum recommended inflation volume or the resting volume is feasible with the adult-sized lma classic , resulting in a high success rate of insertion and adequate range of intracuff pressures ." ]
this single-center , prospective , randomized , double-blind , @-arm , parallel group comparison trial was performed to establish whether the adult-sized laryngeal mask airway ( lma ) classic ( the laryngeal mask company ltd , henley-on-thames , uk ) could be used safely without any consideration of cuff hyperinflation when a cuff of the lma classic was inflated using half the maximum inflation volume or the resting volume before insertion of device . eighty patients aged @ to @ years scheduled for general anesthesia using the lma classic were included . before insertion , the cuff was partially filled with half the maximum inflation volume in the half volume group or the resting volume created by opening the pilot balloon valve to equalize with atmospheric pressure in the resting volume group . several parameters regarding insertion , intracuff pressure , airway leak pressure , and leakage volume/fraction were collected after lma insertion . the lma classic with a partially inflated cuff was successfully inserted in all enrolled patients . both groups had the same success rate of @ % at the first insertion attempt . the half volume group had a lower mean intracuff pressure compared with the resting volume group ( @ @ cm h@o vs @ @ cm h@o ; p = @ ) . there was no difference in airway leak pressure or leakage volume/fraction between the @ groups under mechanical ventilation . the partially inflated cuff method using half the maximum recommended inflation volume or the resting volume is feasible with the adult-sized lma classic , resulting in a high success rate of insertion and adequate range of intracuff pressures .
24,360,025
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "with advances in imaging and radiotherapy , the prognostic value of skull-base invasion in nasopharyngeal carcinoma ( npc ) needs to be reassessed .", "we aimed to define a classification system and evaluate the prognostic value of the classification of magnetic resonance imaging ( mri ) - detected skull-base invasion in npc treated with intensity-modulated radiotherapy ( imrt ) .", "we retrospectively reviewed @ patients who underwent mri and were subsequently histologically diagnosed with nondisseminated npc and treated with imrt .", "mri-detected skull-base invasion was not found to be an independent prognostic factor for overall survival ( os ) , distant metastasis-free survival ( dmfs ) , local relapse-free survival ( lrfs ) , or disease-free survival ( dfs ; p > @ for all ) .", "skull-base invasion was classified according to the incidence of each site ( type i sites inside pharyngobasilar fascia and clivus vs. type ii sites outside pharyngobasilar fascia ) .", "the @-year os , dmfs , lrfs , and dfs rates in the classification of skull-base invasion in npc were @ vs. @ % , @ vs. @ % , @ vs. @ % , and @ vs. @ % , respectively ( p < @ for all ) .", "multivariate analysis indicated the classification of skull-base invasion was an independent prognostic factor .", "mri-detected skull-base invasion is not an independent prognostic factor in patients with npc treated with imrt .", "however , classification according to the site of invasion has prognostic value .", "therefore , patients with various subclassifications of stage t@ disease may receive treatment with different intensities ; however , further studies are warranted to prove this ." ]
with advances in imaging and radiotherapy , the prognostic value of skull-base invasion in nasopharyngeal carcinoma ( npc ) needs to be reassessed . we aimed to define a classification system and evaluate the prognostic value of the classification of magnetic resonance imaging ( mri ) - detected skull-base invasion in npc treated with intensity-modulated radiotherapy ( imrt ) . we retrospectively reviewed @ patients who underwent mri and were subsequently histologically diagnosed with nondisseminated npc and treated with imrt . mri-detected skull-base invasion was not found to be an independent prognostic factor for overall survival ( os ) , distant metastasis-free survival ( dmfs ) , local relapse-free survival ( lrfs ) , or disease-free survival ( dfs ; p > @ for all ) . skull-base invasion was classified according to the incidence of each site ( type i sites inside pharyngobasilar fascia and clivus vs. type ii sites outside pharyngobasilar fascia ) . the @-year os , dmfs , lrfs , and dfs rates in the classification of skull-base invasion in npc were @ vs. @ % , @ vs. @ % , @ vs. @ % , and @ vs. @ % , respectively ( p < @ for all ) . multivariate analysis indicated the classification of skull-base invasion was an independent prognostic factor . mri-detected skull-base invasion is not an independent prognostic factor in patients with npc treated with imrt . however , classification according to the site of invasion has prognostic value . therefore , patients with various subclassifications of stage t@ disease may receive treatment with different intensities ; however , further studies are warranted to prove this .
24,763,663
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "remote patient management for chronic heart failure ( chf ) is gaining increasing importance in health care .", "telemonitoring is defined as daily measuring of health parameters by the patient and their transmission to a telemedical centre .", "the adherence of this action by the patient can be considered as a measure for rpm adoption .", "the randomized controlled clinical trial tim-hf ( nct @ ) was conducted between @ and @ with @ chf patients with the primary endpoint total mortality for a mean follow-up of @ @ months .", "the non-prespecified analysis of adherence to daily measuring of ecg , blood pressure , weight and self-assessment was focused on sociodemographic and disease-related factors of the @ rpm patients .", "the mean adherence to telemonitoring was more than @ % ( absolute adherence : @ @ % , relative adherence : @ @ % ) .", "from the beginning of treatment @ % of the patients ( @/@ ) have shown an adherence below average .", "the high adherence of the majority of the patients was stable for the entire study duration and irrespective of age , sex , severity of the disease and the presence of mild to moderate depression .", "a high adherence can be achieved by individual training of the patient regarding the handling of his disease , the use of telemedical devices and an easy-to-use telemonitoring system .", "the majority of the informed self-determined chf patients nyha class ii/iii are adopting telemonitoring and are adherent in the long term ." ]
remote patient management for chronic heart failure ( chf ) is gaining increasing importance in health care . telemonitoring is defined as daily measuring of health parameters by the patient and their transmission to a telemedical centre . the adherence of this action by the patient can be considered as a measure for rpm adoption . the randomized controlled clinical trial tim-hf ( nct @ ) was conducted between @ and @ with @ chf patients with the primary endpoint total mortality for a mean follow-up of @ @ months . the non-prespecified analysis of adherence to daily measuring of ecg , blood pressure , weight and self-assessment was focused on sociodemographic and disease-related factors of the @ rpm patients . the mean adherence to telemonitoring was more than @ % ( absolute adherence : @ @ % , relative adherence : @ @ % ) . from the beginning of treatment @ % of the patients ( @/@ ) have shown an adherence below average . the high adherence of the majority of the patients was stable for the entire study duration and irrespective of age , sex , severity of the disease and the presence of mild to moderate depression . a high adherence can be achieved by individual training of the patient regarding the handling of his disease , the use of telemedical devices and an easy-to-use telemonitoring system . the majority of the informed self-determined chf patients nyha class ii/iii are adopting telemonitoring and are adherent in the long term .
24,722,932
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "improved smoking cessation rates are urgently required if new zealand is to reach its target of a smokefree nation by @ , during which some @,@ smokers will need to quit .", "nicotine replacement therapy remains a core part of the pharmacological approach to smoking cessation .", "oral nicotine solutions with rapid onset have recently become available .", "we have examined the effect of a nicotine spray and a nicotine patch on smoking cessation for @ months .", "we enrolled potential participants-smokers wanting to quit aged @-@ years , who smoked @ cigarettes per day-with fagerstrm test of nicotine dependence score @ in a double-blind trial in @ trial sites .", "smokers were randomized to a nicotine or placebo spray for @ months , and all received nicotine patches daily for @ months .", "they were followed at regular intervals for @ months .", "a total of @,@ subjects were randomized to nicotine oral spray ( @mg of nicotine free base per spray ) plus nicotine patch or a placebo spray and nicotine patch .", "the nicotine mouth spray plus nicotine patch showed significant improvements in prolonged abstinence for all measures to @ months ( @ consecutive days at each visit for @ months : @ % vs. @ % ; p = @ ) for the combination versus placebo and nicotine patch .", "thereafter , the differences were not significant .", "the addition of a nicotine mouth spray to a nicotine replacement patch in a population of smokers receiving a low level of behavioral support improved early quitting , but the effects were not sustained ." ]
improved smoking cessation rates are urgently required if new zealand is to reach its target of a smokefree nation by @ , during which some @,@ smokers will need to quit . nicotine replacement therapy remains a core part of the pharmacological approach to smoking cessation . oral nicotine solutions with rapid onset have recently become available . we have examined the effect of a nicotine spray and a nicotine patch on smoking cessation for @ months . we enrolled potential participants-smokers wanting to quit aged @-@ years , who smoked @ cigarettes per day-with fagerstrm test of nicotine dependence score @ in a double-blind trial in @ trial sites . smokers were randomized to a nicotine or placebo spray for @ months , and all received nicotine patches daily for @ months . they were followed at regular intervals for @ months . a total of @,@ subjects were randomized to nicotine oral spray ( @mg of nicotine free base per spray ) plus nicotine patch or a placebo spray and nicotine patch . the nicotine mouth spray plus nicotine patch showed significant improvements in prolonged abstinence for all measures to @ months ( @ consecutive days at each visit for @ months : @ % vs. @ % ; p = @ ) for the combination versus placebo and nicotine patch . thereafter , the differences were not significant . the addition of a nicotine mouth spray to a nicotine replacement patch in a population of smokers receiving a low level of behavioral support improved early quitting , but the effects were not sustained .
24,872,027
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "improving the carbohydrate quality of the diet by replacing the common cereal staple white rice ( wr ) with brown rice ( br ) could have beneficial effects on reducing the risk for diabetes and related complications .", "hence we aimed to compare the effects of br , wr , and br with legumes ( brl ) diets on @-h glycemic and insulinemic responses among overweight asian indians .", "fifteen overweight ( body mass index , @ kg/m ( @ ) ) asian indians without diabetes who were @-@ years old participated in a randomized crossover study .", "test meals ( nonisocaloric , ad libitum ) were identical except for the type of rice and the addition of legumes ( @ g/day ) and were provided for @ consecutive days .", "glucose profiles were assessed using the medtronic minimed ( northridge , ca ) ipro@ continuous glucose monitoring device .", "the mean positive change from baseline glucose concentration was calculated as the daily incremental area under the curve ( iauc ) on each test day for @ days and averaged .", "fasting serum insulin was measured prior to and at the end of each test diet .", "the percentage difference in @-day average iauc was @ % lower in the br group than in the wr group ( p = @ ) .", "brl further decreased the glycemic response ( @ % lower compared with wr ( p = @ ) .", "the @-day percentage change in fasting insulin was @ % lower ( p = @ ) for the br group and @ % lower for the brl group compared with the @-day percentage change observed in the wr group .", "the glycemic and insulinemic responses to the br and brl diets were not significantly different .", "consumption of br in place of wr can help reduce @-h glucose and fasting insulin responses among overweight asian indians ." ]
improving the carbohydrate quality of the diet by replacing the common cereal staple white rice ( wr ) with brown rice ( br ) could have beneficial effects on reducing the risk for diabetes and related complications . hence we aimed to compare the effects of br , wr , and br with legumes ( brl ) diets on @-h glycemic and insulinemic responses among overweight asian indians . fifteen overweight ( body mass index , @ kg/m ( @ ) ) asian indians without diabetes who were @-@ years old participated in a randomized crossover study . test meals ( nonisocaloric , ad libitum ) were identical except for the type of rice and the addition of legumes ( @ g/day ) and were provided for @ consecutive days . glucose profiles were assessed using the medtronic minimed ( northridge , ca ) ipro@ continuous glucose monitoring device . the mean positive change from baseline glucose concentration was calculated as the daily incremental area under the curve ( iauc ) on each test day for @ days and averaged . fasting serum insulin was measured prior to and at the end of each test diet . the percentage difference in @-day average iauc was @ % lower in the br group than in the wr group ( p = @ ) . brl further decreased the glycemic response ( @ % lower compared with wr ( p = @ ) . the @-day percentage change in fasting insulin was @ % lower ( p = @ ) for the br group and @ % lower for the brl group compared with the @-day percentage change observed in the wr group . the glycemic and insulinemic responses to the br and brl diets were not significantly different . consumption of br in place of wr can help reduce @-h glucose and fasting insulin responses among overweight asian indians .
24,447,043
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the effects of combination cathodal transcranial direct current stimulation ( tdcs ) and virtual reality ( vr ) therapy for upper extremity ( ue ) training in patients with subacute stroke .", "pilot randomized controlled trial .", "patients were randomly assigned to @ of @ groups : group a received cathodal tdcs , group b received vr , and group c received combination therapy ( cathodal tdcs was simultaneously applied during vr therapy ) .", "university hospital .", "patients ( n = @ ) with impaired unilateral ue motor function after stroke .", "fifteen sessions of treatment over a @-week period .", "the modified ashworth scale , manual muscle test ( mmt ) , manual function test ( mft ) , fugl-meyer scale ( fms ) , and box and block test were used to assess ue function .", "to evaluate activities of daily living , the korean-modified barthel index ( k-mbi ) was used .", "all outcomes were measured before and immediately after treatment .", "after treatment , all groups demonstrated significant improvements in mmt , mft , fms , and k-mbi scores .", "the change in mft and fms scores was different between the @ groups .", "post hoc analysis revealed that the improvement of mft and fms scores in group c was significantly higher than those of the other @ groups .", "in the present pilot study , the combination of brain stimulation using tdcs and peripheral arm training using vr could facilitate a stronger beneficial effect on ue impairment than using each intervention alone .", "this combination therapy might be a helpful method to enhance recovery of the paretic ue in patients with stroke ." ]
to investigate the effects of combination cathodal transcranial direct current stimulation ( tdcs ) and virtual reality ( vr ) therapy for upper extremity ( ue ) training in patients with subacute stroke . pilot randomized controlled trial . patients were randomly assigned to @ of @ groups : group a received cathodal tdcs , group b received vr , and group c received combination therapy ( cathodal tdcs was simultaneously applied during vr therapy ) . university hospital . patients ( n = @ ) with impaired unilateral ue motor function after stroke . fifteen sessions of treatment over a @-week period . the modified ashworth scale , manual muscle test ( mmt ) , manual function test ( mft ) , fugl-meyer scale ( fms ) , and box and block test were used to assess ue function . to evaluate activities of daily living , the korean-modified barthel index ( k-mbi ) was used . all outcomes were measured before and immediately after treatment . after treatment , all groups demonstrated significant improvements in mmt , mft , fms , and k-mbi scores . the change in mft and fms scores was different between the @ groups . post hoc analysis revealed that the improvement of mft and fms scores in group c was significantly higher than those of the other @ groups . in the present pilot study , the combination of brain stimulation using tdcs and peripheral arm training using vr could facilitate a stronger beneficial effect on ue impairment than using each intervention alone . this combination therapy might be a helpful method to enhance recovery of the paretic ue in patients with stroke .
24,239,790
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the safety and efficacy of once-weekly subcutaneous rilonacept @ mg for prevention of gout flares in patients initiating or continuing urate-lowering therapy ( ult ) .", "this phase iii study was conducted in the united states , south africa , europe , and asia .", "adults ( n = @ , @-@ yrs ) with gout , who were initiating or continuing ult , were randomized to treatment with weekly subcutaneous injections of rilonacept @ mg or placebo for @ weeks followed by a @-week safety followup .", "the primary endpoint was safety , assessed by adverse events ( ae ) and laboratory values .", "efficacy was a secondary endpoint .", "demographic and clinical characteristics were similar between treatments ; predominantly male ( @ % ) , mean age @ @ years .", "patients with @ ae were @ % with rilonacept versus @ % placebo , with slightly more ae-related withdrawals with rilonacept ( @ % vs @ % ) because of the greater incidence of injection site reactions ( @ % rilonacept , @ % placebo ) .", "serious ae were similar in both groups , as were serious infections ( @ % placebo , @ % rilonacept ) ; no tuberculosis or opportunistic infections occurred .", "most common ae were headache , arthralgia , injection site erythema , accidental overdose , and pain in extremity .", "of the @ deaths , only @ in the placebo group was considered treatment-related .", "at week @ , rilonacept resulted in @ % fewer gout flares per patient ( p < @ ) , fewer patients with @ and @ gout flares ( p < @ ) , and @ % fewer gout flare days ( p < @ ) relative to placebo .", "weekly subcutaneous administration of rilonacept @ mg showed no new safety signals .", "the safety profile was consistent with previous studies .", "rilonacept also significantly reduced the risk of gout flares .", "clinicaltrials.gov identifier nct@ ; eudract no. @-@-@ ." ]
to evaluate the safety and efficacy of once-weekly subcutaneous rilonacept @ mg for prevention of gout flares in patients initiating or continuing urate-lowering therapy ( ult ) . this phase iii study was conducted in the united states , south africa , europe , and asia . adults ( n = @ , @-@ yrs ) with gout , who were initiating or continuing ult , were randomized to treatment with weekly subcutaneous injections of rilonacept @ mg or placebo for @ weeks followed by a @-week safety followup . the primary endpoint was safety , assessed by adverse events ( ae ) and laboratory values . efficacy was a secondary endpoint . demographic and clinical characteristics were similar between treatments ; predominantly male ( @ % ) , mean age @ @ years . patients with @ ae were @ % with rilonacept versus @ % placebo , with slightly more ae-related withdrawals with rilonacept ( @ % vs @ % ) because of the greater incidence of injection site reactions ( @ % rilonacept , @ % placebo ) . serious ae were similar in both groups , as were serious infections ( @ % placebo , @ % rilonacept ) ; no tuberculosis or opportunistic infections occurred . most common ae were headache , arthralgia , injection site erythema , accidental overdose , and pain in extremity . of the @ deaths , only @ in the placebo group was considered treatment-related . at week @ , rilonacept resulted in @ % fewer gout flares per patient ( p < @ ) , fewer patients with @ and @ gout flares ( p < @ ) , and @ % fewer gout flare days ( p < @ ) relative to placebo . weekly subcutaneous administration of rilonacept @ mg showed no new safety signals . the safety profile was consistent with previous studies . rilonacept also significantly reduced the risk of gout flares . clinicaltrials.gov identifier nct@ ; eudract no. @-@-@ .
25,028,379
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "haemodiafiltration ( hdf ) with high reinfusion volumes is the most effective technique for clearing uraemic toxins .", "there are various modalities depending on the location where the replacement volume is administered in the extracorporeal circuit : pre-dilution , mixed or mid-dilution and post-dilution , in which the infusion is carried out pre-dilution , pre - and post-dilution simultaneously and post-dilution , respectively .", "compare the clearance of small , medium-sized and protein-bound molecules and the convective volume administered in online hdf ( ol-hdf ) in post-dilution and mixed ( pre-post-dilution ) infusion .", "a prospective , randomised , crossover study comparing post-dilution and mixed ol-hdf .", "patients ( n = @ ) were randomly assigned to receive @ sessions in each technique .", "we conducted @ sessions , of which @ were at a scheduled time ( st ) and @ at an effective time ( et ) .", "we determined the reduction rate ( rr ) percentages for various substances and the infusion volumes .", "the rr study was performed using et .", "the kt value obtained was greater with post-dilution ol-hdf -lsb- @ ( @ ) compared to @ ( @ ) litres -rsb- ( p = @ ) when patients were dialysed at st. this difference disappeared when dialysis was performed at et .", "the difference between st and et was greater in mixed hdf than in post-dilution hdf -lsb- @ ( @ ) compared to @ ( @ ) minutes , p = @ -rsb- .", "we found no differences in the rr of the substances analysed .", "mixed ol-hdf is not inferior to post-dilution ol-hdf either in the clearance of small and medium-sized molecules or in the clearance of protein-bound molecules at the same et ." ]
haemodiafiltration ( hdf ) with high reinfusion volumes is the most effective technique for clearing uraemic toxins . there are various modalities depending on the location where the replacement volume is administered in the extracorporeal circuit : pre-dilution , mixed or mid-dilution and post-dilution , in which the infusion is carried out pre-dilution , pre - and post-dilution simultaneously and post-dilution , respectively . compare the clearance of small , medium-sized and protein-bound molecules and the convective volume administered in online hdf ( ol-hdf ) in post-dilution and mixed ( pre-post-dilution ) infusion . a prospective , randomised , crossover study comparing post-dilution and mixed ol-hdf . patients ( n = @ ) were randomly assigned to receive @ sessions in each technique . we conducted @ sessions , of which @ were at a scheduled time ( st ) and @ at an effective time ( et ) . we determined the reduction rate ( rr ) percentages for various substances and the infusion volumes . the rr study was performed using et . the kt value obtained was greater with post-dilution ol-hdf -lsb- @ ( @ ) compared to @ ( @ ) litres -rsb- ( p = @ ) when patients were dialysed at st. this difference disappeared when dialysis was performed at et . the difference between st and et was greater in mixed hdf than in post-dilution hdf -lsb- @ ( @ ) compared to @ ( @ ) minutes , p = @ -rsb- . we found no differences in the rr of the substances analysed . mixed ol-hdf is not inferior to post-dilution ol-hdf either in the clearance of small and medium-sized molecules or in the clearance of protein-bound molecules at the same et .
24,241,365
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "prescribing inhalers without imparting adequate education regarding proper technique of their usage may result in suboptimal clinical improvement and wastage of medication .", "training interventions using a standard check-list may help improve faulty techniques and enhance drug efficacy .", "patients using metered dose inhaler ( mdi ) were included in the study .", "inhaler technique was first evaluated at baseline using a standard check-list of recommended steps ( national institute of health guidelines ; see table ) and scores were given for each step correctly performed .", "those who could not perform all steps correctly were given training intervention .", "the patients were assigned to two methods of educational intervention ; one group was trained by providing written material giving step-wise instructions while the other group was given an actual physical demonstration using a placebo device .", "the technique was re-evaluated and scored following each educational session , and continued till the patient achieved a full score , or for a maximum of @ sessions , whichever occurred earlier .", "median score was calculated after each session and was compared between the two groups .", "each patient was followed up after two months and the re-evaluated the same way .", "one hundred and seventeen subjects were enrolled in the study ( @ in the written group and @ in the practical demonstration group ) .", "at baseline , only @ of the @ subjects could perform all the steps of inhaler usage correctly .", "this patient was , therefore , not provided the inhaler technique education .", "the overall median ( range ) score of the whole group was @ ( range @-@ ) .", "this score rose to @ , @ and @ after each of the three subsequent educational intervention sessions .", "at one-month follow-up , the median score dropped to @ and improved with a repeat educational session as previously done .", "a significant difference was observed in the median score improvement achieved in the practical demonstration group compared with the written instruction group ( @ versus @ respectively , p < @ ) .", "inhalation technique of patients improves after imparting systematic educational intervention .", "a practical demonstration of all the steps proved more effective than simple verbal/written advice .", "in view of increasing errors being committed over a period of time , repeated demonstration of the proper technique using a standard check-list significantly improves the errors committed during inhaler use ." ]
prescribing inhalers without imparting adequate education regarding proper technique of their usage may result in suboptimal clinical improvement and wastage of medication . training interventions using a standard check-list may help improve faulty techniques and enhance drug efficacy . patients using metered dose inhaler ( mdi ) were included in the study . inhaler technique was first evaluated at baseline using a standard check-list of recommended steps ( national institute of health guidelines ; see table ) and scores were given for each step correctly performed . those who could not perform all steps correctly were given training intervention . the patients were assigned to two methods of educational intervention ; one group was trained by providing written material giving step-wise instructions while the other group was given an actual physical demonstration using a placebo device . the technique was re-evaluated and scored following each educational session , and continued till the patient achieved a full score , or for a maximum of @ sessions , whichever occurred earlier . median score was calculated after each session and was compared between the two groups . each patient was followed up after two months and the re-evaluated the same way . one hundred and seventeen subjects were enrolled in the study ( @ in the written group and @ in the practical demonstration group ) . at baseline , only @ of the @ subjects could perform all the steps of inhaler usage correctly . this patient was , therefore , not provided the inhaler technique education . the overall median ( range ) score of the whole group was @ ( range @-@ ) . this score rose to @ , @ and @ after each of the three subsequent educational intervention sessions . at one-month follow-up , the median score dropped to @ and improved with a repeat educational session as previously done . a significant difference was observed in the median score improvement achieved in the practical demonstration group compared with the written instruction group ( @ versus @ respectively , p < @ ) . inhalation technique of patients improves after imparting systematic educational intervention . a practical demonstration of all the steps proved more effective than simple verbal/written advice . in view of increasing errors being committed over a period of time , repeated demonstration of the proper technique using a standard check-list significantly improves the errors committed during inhaler use .
26,410,977
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cigarette smoking leads to upregulation of nicotinic acetylcholine receptors ( nachrs ) in the human brain , including the common @ * nachr subtype .", "while subjective aspects of tobacco dependence have been extensively examined as predictors of quitting smoking with treatment , no studies to our knowledge have yet reported the relationship between the extent of pretreatment upregulation of nachrs and smoking cessation .", "to determine whether the degree of nachr upregulation in smokers predicts quitting with a standard course of treatment .", "eighty-one tobacco-dependent cigarette smokers ( volunteer sample ) underwent positron emission tomographic ( pet ) scanning of the brain with the radiotracer @-fa followed by @ weeks of double-blind , placebo-controlled treatment with nicotine patch ( random assignment ) .", "pretreatment specific binding volume of distribution ( vs/fp ) on pet images ( a value that is proportional to @ * nachr availability ) was determined for @ brain regions of interest , and participant-reported ratings of nicotine dependence , craving , and self-efficacy were collected .", "relationships between these pretreatment measures , treatment type , and outcome were then determined .", "the study took place at academic pet and clinical research centers .", "posttreatment quit status after treatment , defined as a participant report of @ or more days of continuous abstinence and an exhaled carbon monoxide level of @ ppm or less .", "smokers with lower pretreatment vs/fp values ( a potential marker of less severe nachr upregulation ) across all brain regions studied were more likely to quit smoking ( multivariate analysis of covariance , f@ ,@ = @ ; p < @ ) , regardless of treatment group assignment .", "furthermore , pretreatment average vs/fp values provided additional predictive power for likelihood of quitting beyond the self-report measures ( stepwise binary logistic regression , likelihood ratio @ = @ ; p < @ ) .", "smokers with less upregulation of available @ * nachrs have a greater likelihood of quitting with treatment than smokers with more upregulation .", "in addition , the biological marker studied here provided additional predictive power beyond subjectively rated measures known to be associated with smoking cessation outcome .", "while the costly , time-consuming pet procedure used here is not likely to be used clinically , simpler methods for examining @ * nachr upregulation could be tested and applied in the future to help determine which smokers need more intensive and/or lengthier treatment .", "clinicaltrials.gov identifier : nct@ ." ]
cigarette smoking leads to upregulation of nicotinic acetylcholine receptors ( nachrs ) in the human brain , including the common @ * nachr subtype . while subjective aspects of tobacco dependence have been extensively examined as predictors of quitting smoking with treatment , no studies to our knowledge have yet reported the relationship between the extent of pretreatment upregulation of nachrs and smoking cessation . to determine whether the degree of nachr upregulation in smokers predicts quitting with a standard course of treatment . eighty-one tobacco-dependent cigarette smokers ( volunteer sample ) underwent positron emission tomographic ( pet ) scanning of the brain with the radiotracer @-fa followed by @ weeks of double-blind , placebo-controlled treatment with nicotine patch ( random assignment ) . pretreatment specific binding volume of distribution ( vs/fp ) on pet images ( a value that is proportional to @ * nachr availability ) was determined for @ brain regions of interest , and participant-reported ratings of nicotine dependence , craving , and self-efficacy were collected . relationships between these pretreatment measures , treatment type , and outcome were then determined . the study took place at academic pet and clinical research centers . posttreatment quit status after treatment , defined as a participant report of @ or more days of continuous abstinence and an exhaled carbon monoxide level of @ ppm or less . smokers with lower pretreatment vs/fp values ( a potential marker of less severe nachr upregulation ) across all brain regions studied were more likely to quit smoking ( multivariate analysis of covariance , f@ ,@ = @ ; p < @ ) , regardless of treatment group assignment . furthermore , pretreatment average vs/fp values provided additional predictive power for likelihood of quitting beyond the self-report measures ( stepwise binary logistic regression , likelihood ratio @ = @ ; p < @ ) . smokers with less upregulation of available @ * nachrs have a greater likelihood of quitting with treatment than smokers with more upregulation . in addition , the biological marker studied here provided additional predictive power beyond subjectively rated measures known to be associated with smoking cessation outcome . while the costly , time-consuming pet procedure used here is not likely to be used clinically , simpler methods for examining @ * nachr upregulation could be tested and applied in the future to help determine which smokers need more intensive and/or lengthier treatment . clinicaltrials.gov identifier : nct@ .
24,850,280
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the purpose of this study was to describe the process of implementing a diabetes prevention program provided by homecare nurses to residents of public housing communities .", "a cluster randomization pilot study was conducted comparing enhanced standard care ( @ interactive classes on diabetes prevention ) to a diabetes prevention program ( @ interactive classes and behavioral support ) .", "the sample ( n = @ ) was primarily female ( @ % ) , nonwhite ( @ % ) , unpartnered ( @ % ) , with a mean age of @ years , and an average of @ children .", "mixed methods were used to evaluate the implementation process .", "data were collected on attendance , attrition , and protocol implementation .", "interviews were conducted with nurses and community health workers who assisted with program implementation .", "homecare nurses were able to implement a diabetes prevention program in public housing communities , with a protocol implementation of @ % across classes and groups .", "attendance was suboptimal with @ % for the enhanced standard care group and @ % for the diabetes prevention group .", "nurses and community health workers were resourceful and positive about program implementation .", "linking existing resources , such as a homecare agency with a public housing community , is one approach to disseminate diabetes prevention programs ." ]
the purpose of this study was to describe the process of implementing a diabetes prevention program provided by homecare nurses to residents of public housing communities . a cluster randomization pilot study was conducted comparing enhanced standard care ( @ interactive classes on diabetes prevention ) to a diabetes prevention program ( @ interactive classes and behavioral support ) . the sample ( n = @ ) was primarily female ( @ % ) , nonwhite ( @ % ) , unpartnered ( @ % ) , with a mean age of @ years , and an average of @ children . mixed methods were used to evaluate the implementation process . data were collected on attendance , attrition , and protocol implementation . interviews were conducted with nurses and community health workers who assisted with program implementation . homecare nurses were able to implement a diabetes prevention program in public housing communities , with a protocol implementation of @ % across classes and groups . attendance was suboptimal with @ % for the enhanced standard care group and @ % for the diabetes prevention group . nurses and community health workers were resourceful and positive about program implementation . linking existing resources , such as a homecare agency with a public housing community , is one approach to disseminate diabetes prevention programs .
24,251,677
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "randomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease ( ihd ) .", "it is not known if these efficacy results are reflected by real-world effectiveness .", "to evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention ( pci ) or coronary artery bypass grafting ( cabg ) in stable ihd .", "observational cohort study .", "stable ihd patients from @ october @ to @ september @ , identified using a registry of all angiography patients in ontario , canada .", "revascularization , defined as pci/cabg within @ days after index angiography .", "death , myocardial infarction ( mi ) or repeat pci/cabg .", "revascularization was compared to medical therapy using a ) multivariable cox-proportional hazard models with therapy strategy treated as a time-varying covariate ; and b ) a propensity score matched analysis .", "post-angiography medication use was determined .", "we identified @,@ stable ihd patients , of whom @,@ were treated medically , and @,@ were revascularized ( pci = @,@ ; cabg = @,@ ) .", "mean follow-up was @ years .", "revascularization was associated with fewer deaths ( hr @ ; @ % ci @-@ @ ; p < @ ) , mis ( hr @ ; @ % ci @-@ @ ; p < @ ) and repeat pci/cabg ( hr @ ; @ % ci @-@ @ ; p < @ ) than medical therapy .", "in the propensity-matched analysis of @,@ well-matched pairs of revascularized and medical therapy patients , fewer deaths ( @ % vs @ % ; hr @ ; @ % ci @-@ @ ; p < @ ) , mis ( @ % vs @ % ; hr @ ; @ % ci @-@ @ p < @ ) and repeat pci/cabg ( @ % vs @ % ; hr @ ; @ % @-@ @ ; p < @ ) occurred in revascularized patients , over the @ years of follow-up .", "the revascularization patients had higher uptake of clopidogrel ( @ % vs @ % ; p < @ ) , - blockers ( @ % vs @ % ; p = @ ) , and statins ( @ % vs @ % , p < @ ) in the @-year post-angiogram .", "stable ihd patients treated with revascularization had improved risk-adjusted outcomes in clinical practice , potentially due to under-treatment of medical therapy patients ." ]
randomized studies have shown optimal medical therapy to be as efficacious as revascularization in stable ischemic heart disease ( ihd ) . it is not known if these efficacy results are reflected by real-world effectiveness . to evaluate the comparative effectiveness of routine medical therapy versus revascularization with percutaneous coronary intervention ( pci ) or coronary artery bypass grafting ( cabg ) in stable ihd . observational cohort study . stable ihd patients from @ october @ to @ september @ , identified using a registry of all angiography patients in ontario , canada . revascularization , defined as pci/cabg within @ days after index angiography . death , myocardial infarction ( mi ) or repeat pci/cabg . revascularization was compared to medical therapy using a ) multivariable cox-proportional hazard models with therapy strategy treated as a time-varying covariate ; and b ) a propensity score matched analysis . post-angiography medication use was determined . we identified @,@ stable ihd patients , of whom @,@ were treated medically , and @,@ were revascularized ( pci = @,@ ; cabg = @,@ ) . mean follow-up was @ years . revascularization was associated with fewer deaths ( hr @ ; @ % ci @-@ @ ; p < @ ) , mis ( hr @ ; @ % ci @-@ @ ; p < @ ) and repeat pci/cabg ( hr @ ; @ % ci @-@ @ ; p < @ ) than medical therapy . in the propensity-matched analysis of @,@ well-matched pairs of revascularized and medical therapy patients , fewer deaths ( @ % vs @ % ; hr @ ; @ % ci @-@ @ ; p < @ ) , mis ( @ % vs @ % ; hr @ ; @ % ci @-@ @ p < @ ) and repeat pci/cabg ( @ % vs @ % ; hr @ ; @ % @-@ @ ; p < @ ) occurred in revascularized patients , over the @ years of follow-up . the revascularization patients had higher uptake of clopidogrel ( @ % vs @ % ; p < @ ) , - blockers ( @ % vs @ % ; p = @ ) , and statins ( @ % vs @ % , p < @ ) in the @-year post-angiogram . stable ihd patients treated with revascularization had improved risk-adjusted outcomes in clinical practice , potentially due to under-treatment of medical therapy patients .
24,610,309
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "colonoscopy is the most frequent exam used to evaluate colonic mucosa , allowing the diagnosis and treatment of many diseases .", "the appropriate bowel preparation is indispensable for the realization of colonoscopy .", "therefore , it is necessary the use of laxative medications , preferentially by oral administration .", "to compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients ' profile .", "a double-blind prospective study with @ patients , randomized in two groups : one that received polyethilene glycol and another that received lactulose .", "the patients answered to questionnaires to data compilation , as tolerance , symptoms and complications related to preparation .", "besides , it was also evaluated the prepare efficacy related to the presence of fecal residue .", "intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity .", "ten percent of the ones who received lactulose did n't get to finish the preparation and @ % considered the taste `` bad , but tolerable '' .", "the most common subjective symptom after the medication was nausea , especially after lactulose .", "during the exam , most of the patients who used lactulose had a `` light discomfort '' and the ones who used polyethilene glycol considered the discomfort as `` tolerable '' .", "the quality of the preparation was good in @ % , undependable of the medication that was used .", "polyethilene glycol was more tolerable when compared to lactulose , without difference on the quality of the preparation ." ]
colonoscopy is the most frequent exam used to evaluate colonic mucosa , allowing the diagnosis and treatment of many diseases . the appropriate bowel preparation is indispensable for the realization of colonoscopy . therefore , it is necessary the use of laxative medications , preferentially by oral administration . to compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients ' profile . a double-blind prospective study with @ patients , randomized in two groups : one that received polyethilene glycol and another that received lactulose . the patients answered to questionnaires to data compilation , as tolerance , symptoms and complications related to preparation . besides , it was also evaluated the prepare efficacy related to the presence of fecal residue . intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity . ten percent of the ones who received lactulose did n't get to finish the preparation and @ % considered the taste `` bad , but tolerable '' . the most common subjective symptom after the medication was nausea , especially after lactulose . during the exam , most of the patients who used lactulose had a `` light discomfort '' and the ones who used polyethilene glycol considered the discomfort as `` tolerable '' . the quality of the preparation was good in @ % , undependable of the medication that was used . polyethilene glycol was more tolerable when compared to lactulose , without difference on the quality of the preparation .
24,676,290
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare preservative-free ketotifen @ % ophthalmic solution to olopatadine @ % ophthalmic solution in with the treatment of seasonal allergic conjunctivitis ( sac ) in clinical practice .", "this was a comparative , randomised , investigator-masked , pilot clinical study in adult patients with documented history of sac and presenting with moderate to severe itching and conjunctival hyperemia .", "eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for @days .", "the resolution of ocular signs and symptoms was assessed on day @ and day @ .", "itching was also assessed within @minutes following the first instillation ( day @ ) .", "conjunctival impression cytology was performed at each visit to assess the evolution of icam-@ expression ( day @ , @ and @ ) .", "seventy-five patients were randomised ( ketotifen : @ patients ; olopatadine : @ patients ) .", "at day @ , the composite score for primary criteria ( itching , tearing , and conjunctival hyperemia ) improved from @ to @ in the ketotifen group , without statistically significant difference between treatment groups ( p = @ ) .", "there was no relevant difference between treatment groups in other efficacy parameters , except a trend for a more rapid resolution of conjunctival hyperemia in the ketotifen group .", "both drugs were well tolerated , with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day @ ( p = @ ) .", "a rapid and comparable improvement in sac was achieved after @days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions , with a slightly better ocular tolerance with unpreserved ketotifen @ % eye drops ." ]
to compare preservative-free ketotifen @ % ophthalmic solution to olopatadine @ % ophthalmic solution in with the treatment of seasonal allergic conjunctivitis ( sac ) in clinical practice . this was a comparative , randomised , investigator-masked , pilot clinical study in adult patients with documented history of sac and presenting with moderate to severe itching and conjunctival hyperemia . eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for @days . the resolution of ocular signs and symptoms was assessed on day @ and day @ . itching was also assessed within @minutes following the first instillation ( day @ ) . conjunctival impression cytology was performed at each visit to assess the evolution of icam-@ expression ( day @ , @ and @ ) . seventy-five patients were randomised ( ketotifen : @ patients ; olopatadine : @ patients ) . at day @ , the composite score for primary criteria ( itching , tearing , and conjunctival hyperemia ) improved from @ to @ in the ketotifen group , without statistically significant difference between treatment groups ( p = @ ) . there was no relevant difference between treatment groups in other efficacy parameters , except a trend for a more rapid resolution of conjunctival hyperemia in the ketotifen group . both drugs were well tolerated , with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day @ ( p = @ ) . a rapid and comparable improvement in sac was achieved after @days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions , with a slightly better ocular tolerance with unpreserved ketotifen @ % eye drops .
24,388,379
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "adalimumab is a fully human , monoclonal antibody against tumor necrosis factor that is approved in western countries for the treatment of moderately to severely active ulcerative colitis ( uc ) .", "this @-week , phase @/@ , randomized , double-blind study evaluated adalimumab for induction and maintenance treatment in @ anti-tnf-naive japanese patients with uc who were refractory to corticosteroids , immunomodulators , or both .", "patients received placebo , adalimumab @/@ ( @mg at week @ , then @mg every other week ) , or adalimumab @/@ ( @/@mg at weeks @/@ , then @mg every other week ) in addition to background uc therapy .", "at week @ , remission rates were similar among treatment arms , but more patients treated with adalimumab @/@ achieved response ( placebo , @ % ; @/@ , @ % ; @/@ , @ % ; p = @ for @/@ vs placebo ) and mucosal healing ( placebo , @ % ; @/@ , @ % ; @/@ , @ % ; p = @ for @/@ vs placebo ) compared with placebo .", "at week @ , more patients receiving adalimumab @mg every other week achieved response ( @ vs @ % ; p = @ ) , remission ( @ vs @ % ; p = @ ) , and mucosal healing ( @ vs @ % ; p = @ ) compared with placebo .", "week @ response to adalimumab was associated with greater rates of response ( @ % ) , remission ( @ % ) , and mucosal healing ( @ % ) at week @ relative to the overall population .", "rates of serious adverse events were similar between treatment arms .", "induction with adalimumab @/@mg led to early response and mucosal healing .", "maintenance adalimumab had greater rates of long-term response , remission , and mucosal healing compared with placebo .", "no new safety signals were identified ." ]
adalimumab is a fully human , monoclonal antibody against tumor necrosis factor that is approved in western countries for the treatment of moderately to severely active ulcerative colitis ( uc ) . this @-week , phase @/@ , randomized , double-blind study evaluated adalimumab for induction and maintenance treatment in @ anti-tnf-naive japanese patients with uc who were refractory to corticosteroids , immunomodulators , or both . patients received placebo , adalimumab @/@ ( @mg at week @ , then @mg every other week ) , or adalimumab @/@ ( @/@mg at weeks @/@ , then @mg every other week ) in addition to background uc therapy . at week @ , remission rates were similar among treatment arms , but more patients treated with adalimumab @/@ achieved response ( placebo , @ % ; @/@ , @ % ; @/@ , @ % ; p = @ for @/@ vs placebo ) and mucosal healing ( placebo , @ % ; @/@ , @ % ; @/@ , @ % ; p = @ for @/@ vs placebo ) compared with placebo . at week @ , more patients receiving adalimumab @mg every other week achieved response ( @ vs @ % ; p = @ ) , remission ( @ vs @ % ; p = @ ) , and mucosal healing ( @ vs @ % ; p = @ ) compared with placebo . week @ response to adalimumab was associated with greater rates of response ( @ % ) , remission ( @ % ) , and mucosal healing ( @ % ) at week @ relative to the overall population . rates of serious adverse events were similar between treatment arms . induction with adalimumab @/@mg led to early response and mucosal healing . maintenance adalimumab had greater rates of long-term response , remission , and mucosal healing compared with placebo . no new safety signals were identified .
24,363,029
[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "electrical reconnection of the pulmonary veins ( pvs ) plays a key role in the recurrence of atrial fibrillation ( af ) after ablative treatment .", "this randomized controlled study tested the hypothesis that prolonged ablations , on areas that may be critical for left atrial ( la ) - pv conduction , can significantly reduce the rate of acute pv reconnection and af recurrence .", "patients with paroxysmal af were randomly assigned to either a control or an add-on group.ostial pv isolation ( pvi ) was performed by point-to-point rf ablation ( irrigated tip , @ watts , @ seconds ) .", "an ostial segment was assumed to be critical for la-pv connection if any of the following reactions occurred during rf application : ( @ ) sudden delay of la-pv conduction , ( @ ) change of activation sequence , and ( @ ) pvi .", "in this case , rf application was prolonged from @ seconds to @ seconds in the add-on group only .", "a total of @ patients ( @ @ years , @ female ) were assigned to a control ( n = @ ) and an add-on ( n = @ ) group .", "ablation time was longer in the add-on ( @ @ minutes vs @ @ minutes , p = @ ) .", "acute pv reconnection was observed in @ of @ controls and in eight of @ add-on patients ( @ % vs @ % , p < @ ) .", "during a follow-up of @ months , af recurred in @ of @ controls and in @ of @ add-on patients ( @ % vs @ % , p = @ ) after a single ablation procedure .", "prolonged radiofrequency application on critical segments of la-pv connection is a safe and effective ablative strategy that significantly reduces acute pv reconnection and af recurrence rates after a single ablation procedure for paroxysmal af ." ]
electrical reconnection of the pulmonary veins ( pvs ) plays a key role in the recurrence of atrial fibrillation ( af ) after ablative treatment . this randomized controlled study tested the hypothesis that prolonged ablations , on areas that may be critical for left atrial ( la ) - pv conduction , can significantly reduce the rate of acute pv reconnection and af recurrence . patients with paroxysmal af were randomly assigned to either a control or an add-on group.ostial pv isolation ( pvi ) was performed by point-to-point rf ablation ( irrigated tip , @ watts , @ seconds ) . an ostial segment was assumed to be critical for la-pv connection if any of the following reactions occurred during rf application : ( @ ) sudden delay of la-pv conduction , ( @ ) change of activation sequence , and ( @ ) pvi . in this case , rf application was prolonged from @ seconds to @ seconds in the add-on group only . a total of @ patients ( @ @ years , @ female ) were assigned to a control ( n = @ ) and an add-on ( n = @ ) group . ablation time was longer in the add-on ( @ @ minutes vs @ @ minutes , p = @ ) . acute pv reconnection was observed in @ of @ controls and in eight of @ add-on patients ( @ % vs @ % , p < @ ) . during a follow-up of @ months , af recurred in @ of @ controls and in @ of @ add-on patients ( @ % vs @ % , p = @ ) after a single ablation procedure . prolonged radiofrequency application on critical segments of la-pv connection is a safe and effective ablative strategy that significantly reduces acute pv reconnection and af recurrence rates after a single ablation procedure for paroxysmal af .
24,883,449
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "low-contrast visual acuity ( lcva ) , a sensitive measure of visual function in multiple sclerosis ( ms ) , demonstrated treatment effects as a secondary outcome measure in the phase @ trial of natalizumab , affirm .", "in these posttrial analyses , we studied the relation of visual function to quality of life ( qol ) , magnetic resonance imaging ( mri ) measures , and expanded disability status scale ( edss ) scores .", "at baseline and at @ and @ weeks in affirm , patients underwent binocular testing of lcva ( @ % and @ % contrast ) and high-contrast visual acuity ( hcva ) .", "vision-specific qol was assessed by the impact of visual impairment scale ( ivis ) , whereas the sf-@ health survey and visual analog scale were administered as generic qol measures and the edss as a measure of neurologic impairment .", "among qol measures , ivis scores showed the most significant correlations with visual dysfunction at all time points in the trial ( r = -@ to -@ , p < @ for lcva and hcva ) .", "higher mri t@ - and t@-lesion volumes were also associated with worse vision scores at all time points ( p < @ ) .", "clinically meaningful worsening ( progression ) of lcva was noted in substantial proportions of patients in affirm and was prevalent even among those without edss progression over @ years ( @ % with lcva progression at @ % contrast ; @ % at @ % contrast ) .", "hcva worsened in only @ % of patients without edss progression .", "loss of visual function , particularly as measured by lcva , was common in affirm , occurring in > @ % of patients .", "both lcva and hcva scores reflect vision-specific aspects of qol , but lcva provides information about disability progression not entirely captured by the edss .", "vision represents a key dimension of outcome assessment for ms and adds valuable information on disability and qol that can be useful to clinicians ." ]
low-contrast visual acuity ( lcva ) , a sensitive measure of visual function in multiple sclerosis ( ms ) , demonstrated treatment effects as a secondary outcome measure in the phase @ trial of natalizumab , affirm . in these posttrial analyses , we studied the relation of visual function to quality of life ( qol ) , magnetic resonance imaging ( mri ) measures , and expanded disability status scale ( edss ) scores . at baseline and at @ and @ weeks in affirm , patients underwent binocular testing of lcva ( @ % and @ % contrast ) and high-contrast visual acuity ( hcva ) . vision-specific qol was assessed by the impact of visual impairment scale ( ivis ) , whereas the sf-@ health survey and visual analog scale were administered as generic qol measures and the edss as a measure of neurologic impairment . among qol measures , ivis scores showed the most significant correlations with visual dysfunction at all time points in the trial ( r = -@ to -@ , p < @ for lcva and hcva ) . higher mri t@ - and t@-lesion volumes were also associated with worse vision scores at all time points ( p < @ ) . clinically meaningful worsening ( progression ) of lcva was noted in substantial proportions of patients in affirm and was prevalent even among those without edss progression over @ years ( @ % with lcva progression at @ % contrast ; @ % at @ % contrast ) . hcva worsened in only @ % of patients without edss progression . loss of visual function , particularly as measured by lcva , was common in affirm , occurring in > @ % of patients . both lcva and hcva scores reflect vision-specific aspects of qol , but lcva provides information about disability progression not entirely captured by the edss . vision represents a key dimension of outcome assessment for ms and adds valuable information on disability and qol that can be useful to clinicians .
25,370,598
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the objective of this study was to assess and compare the features of the bemfola , gonal-f and puregon injection pens .", "females who intended to undergo hormonal treatment received the three different pens in a randomized , consecutive sequence .", "for each of the pens , the potential patients completed an injection pen assessment questionnaire , as well as a questionnaire comparing the handling , convenience and preference among the three pens .", "the mean score on the visual analogue scale ( vas ) for the bemfola pen ( bp ) was @ @ ; for the puregon pen ( pp ) , @ @ ; and for the gonal-f pen ( gp ) , @ @ .", "the bp was superior to both competitor devices in pen size , inconspicuousness , ease of use and dose changing ; no significant differences to both competitor pens were observed in the way the pen looks , the way the pen feels and the ease of injection of the volume .", "the ` overall ' assessment was significantly better for the bp when compared to the gp ( p = @ ) , while no significant difference was observed between the bp and the pp .", "this study demonstrated significantly higher ratings for pen size , inconspicuousness , ease of use and dose adjustment for the bp compared to other marketed pens ." ]
the objective of this study was to assess and compare the features of the bemfola , gonal-f and puregon injection pens . females who intended to undergo hormonal treatment received the three different pens in a randomized , consecutive sequence . for each of the pens , the potential patients completed an injection pen assessment questionnaire , as well as a questionnaire comparing the handling , convenience and preference among the three pens . the mean score on the visual analogue scale ( vas ) for the bemfola pen ( bp ) was @ @ ; for the puregon pen ( pp ) , @ @ ; and for the gonal-f pen ( gp ) , @ @ . the bp was superior to both competitor devices in pen size , inconspicuousness , ease of use and dose changing ; no significant differences to both competitor pens were observed in the way the pen looks , the way the pen feels and the ease of injection of the volume . the ` overall ' assessment was significantly better for the bp when compared to the gp ( p = @ ) , while no significant difference was observed between the bp and the pp . this study demonstrated significantly higher ratings for pen size , inconspicuousness , ease of use and dose adjustment for the bp compared to other marketed pens .
25,325,925
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the effects , and their reversibility , of multiple oral voriconazole doses on a variety of visual tests in healthy male volunteers .", "single-center , double-blind , randomized , placebo-controlled , parallel-group study in @ volunteers who received voriconazole ( n = @ , @ mg every @ h on day @ , then @ mg every @ h for @ days ) or matched placebo ( n = @ ) .", "electroretinograms ( ergs ) and ophthalmological examinations were performed at screening , throughout the study and at follow-up .", "fifteen ( @ % ) volunteers treated with voriconazole experienced @ treatment-related visual adverse events ( aes ) ; these included enhanced visual perceptions , blurred vision , color vision changes and photophobia .", "no serious aes were reported .", "voriconazole reduced from baseline scotopic maximal a - and b-wave amplitude , shortened implicit time and decreased oscillatory potential amplitude compared with placebo .", "under photopic conditions , the @-hz flicker response amplitude was significantly reduced and was accompanied by a slight but nonsignificant prolongation of peak time .", "these effects did not progress in degree over the treatment period , and mean changes from baseline in erg parameters were similar to placebo by day @ ( @ days after end of treatment ) .", "in the first week , color vision discrimination was impaired in the tritan axis , although this resolved by end of treatment and was similar to placebo by day @ .", "mean deviation in the static visual field indicated increased sensitivity following voriconazole treatment , correlating with decreased amplitude in conjunction with shortened implicit time .", "effects of voriconazole on altered visual perception , erg , color vision and static visual field thresholds are nonprogressive over a treatment period and reversible .", "it is hypothesized that voriconazole has a pharmacological effect on rod and cone pathways including a possible mechanism of disinhibition that reversibly puts the retina in a more light-adapted state and leads to increased relative contrast sensitivity ." ]
to investigate the effects , and their reversibility , of multiple oral voriconazole doses on a variety of visual tests in healthy male volunteers . single-center , double-blind , randomized , placebo-controlled , parallel-group study in @ volunteers who received voriconazole ( n = @ , @ mg every @ h on day @ , then @ mg every @ h for @ days ) or matched placebo ( n = @ ) . electroretinograms ( ergs ) and ophthalmological examinations were performed at screening , throughout the study and at follow-up . fifteen ( @ % ) volunteers treated with voriconazole experienced @ treatment-related visual adverse events ( aes ) ; these included enhanced visual perceptions , blurred vision , color vision changes and photophobia . no serious aes were reported . voriconazole reduced from baseline scotopic maximal a - and b-wave amplitude , shortened implicit time and decreased oscillatory potential amplitude compared with placebo . under photopic conditions , the @-hz flicker response amplitude was significantly reduced and was accompanied by a slight but nonsignificant prolongation of peak time . these effects did not progress in degree over the treatment period , and mean changes from baseline in erg parameters were similar to placebo by day @ ( @ days after end of treatment ) . in the first week , color vision discrimination was impaired in the tritan axis , although this resolved by end of treatment and was similar to placebo by day @ . mean deviation in the static visual field indicated increased sensitivity following voriconazole treatment , correlating with decreased amplitude in conjunction with shortened implicit time . effects of voriconazole on altered visual perception , erg , color vision and static visual field thresholds are nonprogressive over a treatment period and reversible . it is hypothesized that voriconazole has a pharmacological effect on rod and cone pathways including a possible mechanism of disinhibition that reversibly puts the retina in a more light-adapted state and leads to increased relative contrast sensitivity .
24,925,440
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "acute exacerbations of chronic obstructive pulmonary disease ( aecop ) are key events in the natural history of the disease .", "patients with more aecopd have worse prognosis .", "there is a need of innovative models of care for patients with severe copd and frequent aecopd , and telehealth ( th ) is part of these programs .", "in a cluster assignment , controlled trial study design , we recruited @ patients , @ in home telehealth ( ht ) and @ in conventional care ( cc ) .", "all participants had a prior diagnosis of copd with a post-bronchodilator forced expiratory volume ( fev@ ) % predicted < @ % , age @ years , were on long-term home oxygen therapy , and non-smokers .", "patients in the ht group measured their vital signs on a daily bases , and data were transmitted automatically to a clinical monitoring center for followed-up , and who escalated clinical alerts to a pneumologist .", "after @-month of monitoring and follow-up , there was a significant reduction in er visits ( @ in ht vs. @ in cc ) , hospitalizations ( @ vs. @ ) , length of hospital stay in ( @ vs. @ days ) , and even need for non-invasive mechanical ventilation ( @ vs. @ ) , all p < @ .", "time to the first severe aecopd increased from @ days in cc to @ days in ht ( k-m p < @ ) .", "there was no study withdrawals associated with technology .", "all patients showed a high level of satisfaction with the ht program .", "we conclude that ht in elderly , severe copd patients with multiple comorbidities is safe and efficacious in reducing healthcare resources utilization ." ]
acute exacerbations of chronic obstructive pulmonary disease ( aecop ) are key events in the natural history of the disease . patients with more aecopd have worse prognosis . there is a need of innovative models of care for patients with severe copd and frequent aecopd , and telehealth ( th ) is part of these programs . in a cluster assignment , controlled trial study design , we recruited @ patients , @ in home telehealth ( ht ) and @ in conventional care ( cc ) . all participants had a prior diagnosis of copd with a post-bronchodilator forced expiratory volume ( fev@ ) % predicted < @ % , age @ years , were on long-term home oxygen therapy , and non-smokers . patients in the ht group measured their vital signs on a daily bases , and data were transmitted automatically to a clinical monitoring center for followed-up , and who escalated clinical alerts to a pneumologist . after @-month of monitoring and follow-up , there was a significant reduction in er visits ( @ in ht vs. @ in cc ) , hospitalizations ( @ vs. @ ) , length of hospital stay in ( @ vs. @ days ) , and even need for non-invasive mechanical ventilation ( @ vs. @ ) , all p < @ . time to the first severe aecopd increased from @ days in cc to @ days in ht ( k-m p < @ ) . there was no study withdrawals associated with technology . all patients showed a high level of satisfaction with the ht program . we conclude that ht in elderly , severe copd patients with multiple comorbidities is safe and efficacious in reducing healthcare resources utilization .
24,433,744
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate whether premature infants who received an exclusive human milk ( hm ) - based diet and a hm-derived cream supplement ( cream ) would have weight gain ( g/kg/d ) at least as good as infants receiving a standard feeding regimen ( control ) .", "in a prospective noninferiority , randomized , unmasked study , infants with a birth weight @-@ g were randomly assigned to the control or cream group .", "the control group received mother 's own milk or donor hm with donor hm-derived fortifier .", "the cream group received a hm-derived cream supplement if the energy density of the hm tested < @ kcal/oz using a near infrared hm analyzer .", "infants were continued on the protocol until @ weeks postmenstrual age .", "primary outcomes included growth velocities and amount of donor hm-derived fortifier used .", "the hypothesis of noninferiority was established if the lower bound of the one-sided @ % ci for the difference in weight velocities exceeded -@ g/kg/day .", "there were no differences between groups in baseline demographics for the @ infants studied except racial distribution ( p = @ ) .", "the cream group ( n = @ ) had superior weight ( @ @ vs @ @ g/kg/d , p = @ ) and length ( @ @ vs @ @ cm/wk , p = @ ) velocity compared with the control group ( n = @ ) .", "there were no significant differences in amount of fortifier used between study groups .", "the @-sided @ % lower bound of the ci for the difference in mean velocity ( cream-control ) was @ g/kg/d .", "premature infants who received hm-derived cream to fortified hm had improved weight and length velocity compared with the control group .", "hm-derived cream should be considered an adjunctive supplement to an exclusive hm-based diet to improve growth rates in premature infants ." ]
to evaluate whether premature infants who received an exclusive human milk ( hm ) - based diet and a hm-derived cream supplement ( cream ) would have weight gain ( g/kg/d ) at least as good as infants receiving a standard feeding regimen ( control ) . in a prospective noninferiority , randomized , unmasked study , infants with a birth weight @-@ g were randomly assigned to the control or cream group . the control group received mother 's own milk or donor hm with donor hm-derived fortifier . the cream group received a hm-derived cream supplement if the energy density of the hm tested < @ kcal/oz using a near infrared hm analyzer . infants were continued on the protocol until @ weeks postmenstrual age . primary outcomes included growth velocities and amount of donor hm-derived fortifier used . the hypothesis of noninferiority was established if the lower bound of the one-sided @ % ci for the difference in weight velocities exceeded -@ g/kg/day . there were no differences between groups in baseline demographics for the @ infants studied except racial distribution ( p = @ ) . the cream group ( n = @ ) had superior weight ( @ @ vs @ @ g/kg/d , p = @ ) and length ( @ @ vs @ @ cm/wk , p = @ ) velocity compared with the control group ( n = @ ) . there were no significant differences in amount of fortifier used between study groups . the @-sided @ % lower bound of the ci for the difference in mean velocity ( cream-control ) was @ g/kg/d . premature infants who received hm-derived cream to fortified hm had improved weight and length velocity compared with the control group . hm-derived cream should be considered an adjunctive supplement to an exclusive hm-based diet to improve growth rates in premature infants .
25,130,571
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "serum markers are used before pelvic imaging to improve specificity and positive predictive value ( ppv ) of ovarian cancer multimodal screening strategies .", "we conducted a randomized controlled pilot trial to estimate surgical ppv of a `` @ of @ tests positive '' screening rule , and to compare use of he@ as a first-line ( arm @ ) versus a second-line ( arm @ ) screen , in women at high and elevated risk for epithelial ovarian cancer ( eoc ) at five study sites .", "semiannual screening was offered to @ women ages @ to @ years with deleterious brca germline mutations and to @ women ages @ to @ years with pedigrees suggesting inherited susceptibility .", "annual screening was offered to @ women ages @ to @ years ( risk group @ ) with epidemiologic and serum marker risk factors .", "rising marker levels were identified using the parametric empirical bayes algorithm .", "both strategies yielded surgical ppv above @ % .", "protocol-indicated surgery was performed in @ women , identifying two ovarian malignancies and yielding a surgical ppv in both arms combined of @ % ( @ % confidence interval : @ % -@ % ) , @ % in arm @ and @ % in arm @ .", "surgical consultation was recommended for @ women ( @ in arm @ and @ in arm @ ) .", "on the basis of @ women with at least @ of @ tests positive ( ca@ , he@ , or imaging ) , an intent-to-treat analysis yielded ppv of @ % in arm @ and @ % in arm @ .", "positive screens were more frequent when he@ was included in the primary screen .", "he@ may be useful as a confirmatory screen when rising ca@ is used alone as a primary screen ." ]
serum markers are used before pelvic imaging to improve specificity and positive predictive value ( ppv ) of ovarian cancer multimodal screening strategies . we conducted a randomized controlled pilot trial to estimate surgical ppv of a `` @ of @ tests positive '' screening rule , and to compare use of he@ as a first-line ( arm @ ) versus a second-line ( arm @ ) screen , in women at high and elevated risk for epithelial ovarian cancer ( eoc ) at five study sites . semiannual screening was offered to @ women ages @ to @ years with deleterious brca germline mutations and to @ women ages @ to @ years with pedigrees suggesting inherited susceptibility . annual screening was offered to @ women ages @ to @ years ( risk group @ ) with epidemiologic and serum marker risk factors . rising marker levels were identified using the parametric empirical bayes algorithm . both strategies yielded surgical ppv above @ % . protocol-indicated surgery was performed in @ women , identifying two ovarian malignancies and yielding a surgical ppv in both arms combined of @ % ( @ % confidence interval : @ % -@ % ) , @ % in arm @ and @ % in arm @ . surgical consultation was recommended for @ women ( @ in arm @ and @ in arm @ ) . on the basis of @ women with at least @ of @ tests positive ( ca@ , he@ , or imaging ) , an intent-to-treat analysis yielded ppv of @ % in arm @ and @ % in arm @ . positive screens were more frequent when he@ was included in the primary screen . he@ may be useful as a confirmatory screen when rising ca@ is used alone as a primary screen .
24,789,859
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "following traumatic brain injury ( tbi ) , individuals may experience chronic problems with irritability or aggression , which may need treatment to minimize the negative impact on their relationships , home life , social interactions , community participation , and employment", ": to test the a priori hypothesis that amantadine reduces irritability ( primary hypothesis ) and aggression ( secondary hypothesis ) among individuals greater than @ months post-tbi methods : : a total of @ individuals greater than @ months post-tbi referred for irritability management were enrolled in a parallel-group , randomized , double-blind , placebo-controlled trial of amantadine ( n = @ ) versus placebo ( n = @ ) .", "study participants were randomly assigned to receive amantadine hydrochloride @ mg twice daily versus equivalent placebo for @ days .", "symptoms of irritability and aggression were measured before and after treatment using the neuropsychiatric inventory irritability ( npi-i ) and aggression ( npi-a ) domains , as well as the npi-distress for these domains", ": in the amantadine group , @ % improved at least @ points on the npi-i , compared with @ % in the group that received placebo ( p = @ ) .", "mean change in npi-i was -@ in the amantadine group and -@ in the placebo group ( p = @ ) .", "when excluding individuals with minimal to no baseline aggression , mean change in npi-a was -@ in the amantadine group and -@ in the placebo group ( p = @ ) .", "mean changes in npi-i and npi-a distress were not statistically significant between the amantadine and placebo groups .", "adverse event occurrence did not differ between the @ groups", ": amantadine @ mg every morning and at noon appears an effective and safe means of reducing frequency and severity of irritability and aggression among individuals with tbi and sufficient creatinine clearance ." ]
following traumatic brain injury ( tbi ) , individuals may experience chronic problems with irritability or aggression , which may need treatment to minimize the negative impact on their relationships , home life , social interactions , community participation , and employment : to test the a priori hypothesis that amantadine reduces irritability ( primary hypothesis ) and aggression ( secondary hypothesis ) among individuals greater than @ months post-tbi methods : : a total of @ individuals greater than @ months post-tbi referred for irritability management were enrolled in a parallel-group , randomized , double-blind , placebo-controlled trial of amantadine ( n = @ ) versus placebo ( n = @ ) . study participants were randomly assigned to receive amantadine hydrochloride @ mg twice daily versus equivalent placebo for @ days . symptoms of irritability and aggression were measured before and after treatment using the neuropsychiatric inventory irritability ( npi-i ) and aggression ( npi-a ) domains , as well as the npi-distress for these domains : in the amantadine group , @ % improved at least @ points on the npi-i , compared with @ % in the group that received placebo ( p = @ ) . mean change in npi-i was -@ in the amantadine group and -@ in the placebo group ( p = @ ) . when excluding individuals with minimal to no baseline aggression , mean change in npi-a was -@ in the amantadine group and -@ in the placebo group ( p = @ ) . mean changes in npi-i and npi-a distress were not statistically significant between the amantadine and placebo groups . adverse event occurrence did not differ between the @ groups : amantadine @ mg every morning and at noon appears an effective and safe means of reducing frequency and severity of irritability and aggression among individuals with tbi and sufficient creatinine clearance .
24,263,176
[ "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the effect of aerobic exercise training ( aet ) and cognitive-behavioral therapy ( cbt ) on chronic fatigue in patients with facioscapulohumeral muscular dystrophy ( fshd ) .", "we performed a multicenter , assessor-blinded , randomized clinical trial ( rct ) .", "fifty-seven patients with fshd type @ with severe chronic fatigue were randomly allocated to aet , cbt , or usual care ( uc ) .", "outcomes were assessed before treatment , following @ weeks of intervention , and after a @-week follow-up .", "a linear mixed model for repeated measurements was used to study the estimated group differences .", "following treatment , both the aet ( @ participants ) and cbt ( @ participants ) intervention groups had less fatigue relative to the uc group ( @ participants ) , with a difference of -@ for aet ( @ % confidence interval -lsb- ci -rsb- -@ to -@ ) and -@ for cbt ( @ % ci -@ to -@ ) .", "these beneficial effects lasted through follow-up , with a difference of -@ for aet ( @ % ci -@ to -@ ) and -@ for cbt ( @ % ci -@ to -@ ) .", "the patients who received cbt had an increase in registered and experienced physical activity , sleep quality , and social participation .", "the patients who received aet had an increase in registered physical activity only .", "the increase in registered physical activity in both groups and the improvement in social participation following cbt were still present at follow-up .", "this rct shows that aet and cbt can ameliorate chronic fatigue in patients with fshd .", "this study provides class iii evidence that , in patients with fshd type @ and severe chronic fatigue , aet or cbt reduces the severity of chronic fatigue ." ]
to investigate the effect of aerobic exercise training ( aet ) and cognitive-behavioral therapy ( cbt ) on chronic fatigue in patients with facioscapulohumeral muscular dystrophy ( fshd ) . we performed a multicenter , assessor-blinded , randomized clinical trial ( rct ) . fifty-seven patients with fshd type @ with severe chronic fatigue were randomly allocated to aet , cbt , or usual care ( uc ) . outcomes were assessed before treatment , following @ weeks of intervention , and after a @-week follow-up . a linear mixed model for repeated measurements was used to study the estimated group differences . following treatment , both the aet ( @ participants ) and cbt ( @ participants ) intervention groups had less fatigue relative to the uc group ( @ participants ) , with a difference of -@ for aet ( @ % confidence interval -lsb- ci -rsb- -@ to -@ ) and -@ for cbt ( @ % ci -@ to -@ ) . these beneficial effects lasted through follow-up , with a difference of -@ for aet ( @ % ci -@ to -@ ) and -@ for cbt ( @ % ci -@ to -@ ) . the patients who received cbt had an increase in registered and experienced physical activity , sleep quality , and social participation . the patients who received aet had an increase in registered physical activity only . the increase in registered physical activity in both groups and the improvement in social participation following cbt were still present at follow-up . this rct shows that aet and cbt can ameliorate chronic fatigue in patients with fshd . this study provides class iii evidence that , in patients with fshd type @ and severe chronic fatigue , aet or cbt reduces the severity of chronic fatigue .
25,339,206
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]
[ "to compare intraindividually two macrocyclic contrast agents - gadobutrol and gadoterate meglumine ( gd-dota ) - for dynamic and quantitative assessment of relative enhancement ( re ) in benign and malignant breast lesions .", "this was an ethically approved , prospective , single-centre , randomized , crossover study in @ women with suspected breast lesions referred for magnetic resonance imaging ( mri ) .", "each patient underwent one examination with gadobutrol and one with gd-dota ( @ mmol/kg bw ) on a @ t system @ - @ days apart .", "dynamic , t@-weighted , @d gradient echo sequences were acquired under identical conditions .", "quantitative evaluation with at least three regions of interest ( roi ) per lesion was performed .", "primary endpoint was re during the initial postcontrast phase after the first and second dynamic acquisition , and peak re .", "all lesions were histologically proven ; differences between the examinations were evaluated .", "forty-five patients with a total of @ benign and @ malignant lesions were assessed .", "mean re was significantly higher for gadobutrol than gd-dota ( p < @ ) .", "gadobutrol showed significantly less washout ( @ % ) than gd-dota ( @ % ) in malignant lesions ( p = @ ) conclusions : gadobutrol has higher re values compared with gd-dota , whereas gd-dota shows more marked washout in malignant lesions .", "this might improve the detection of breast lesions and influence the specificity of breast mri-imaging ." ]
to compare intraindividually two macrocyclic contrast agents - gadobutrol and gadoterate meglumine ( gd-dota ) - for dynamic and quantitative assessment of relative enhancement ( re ) in benign and malignant breast lesions . this was an ethically approved , prospective , single-centre , randomized , crossover study in @ women with suspected breast lesions referred for magnetic resonance imaging ( mri ) . each patient underwent one examination with gadobutrol and one with gd-dota ( @ mmol/kg bw ) on a @ t system @ - @ days apart . dynamic , t@-weighted , @d gradient echo sequences were acquired under identical conditions . quantitative evaluation with at least three regions of interest ( roi ) per lesion was performed . primary endpoint was re during the initial postcontrast phase after the first and second dynamic acquisition , and peak re . all lesions were histologically proven ; differences between the examinations were evaluated . forty-five patients with a total of @ benign and @ malignant lesions were assessed . mean re was significantly higher for gadobutrol than gd-dota ( p < @ ) . gadobutrol showed significantly less washout ( @ % ) than gd-dota ( @ % ) in malignant lesions ( p = @ ) conclusions : gadobutrol has higher re values compared with gd-dota , whereas gd-dota shows more marked washout in malignant lesions . this might improve the detection of breast lesions and influence the specificity of breast mri-imaging .
25,249,313
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS" ]
[ "the maastricht , asia-pacific consensus guidelines strongly recommend eradication of helicobacter pylori in patients who have a history of gastric cancer .", "this open-label , single-center , randomized controlled trial was conducted to investigate the appropriate timing of eradication for patients undergoing gastrectomy .", "one hundred and fifty patients scheduled to undergo gastrectomy were allocated to either a preoperative or a postoperative group .", "the eradication regimen was a common triple therapy : lansoprazole , amoxicillin , and clarithromycin .", "patients in the preoperative group were treated with the regimen , followed by surgery , and patients in the postoperative group were treated after postoperative day @ .", "the primary end point was the proportion of patients achieving successful eradication in the remnant stomach .", "the definition of successful eradication was negativity in both the c@ urea breath test and for the antigen in feces at @ months after surgery .", "eight patients were excluded , and the remaining one hundred and forty-two , @ in the preoperative group and @ in the postoperative group , were included on an intention to treat basis .", "the procedures used were gastrectomy with billroth i , roux-en-y , and pylorus-preserving gastrectomy in @ , @ , and @ patients , respectively .", "the proportion of patients showing successful eradication hardly differed between the @ groups , @ % vs @ % ( p = @ ) in the pre - and postoperative groups , respectively .", "subgroup analysis also demonstrated no significant difference among the reconstruction methods used .", "preoperative h pylori eradication therapy for gastric cancer patients scheduled for gastrectomy is not necessary , regardless of the planned reconstruction procedure ." ]
the maastricht , asia-pacific consensus guidelines strongly recommend eradication of helicobacter pylori in patients who have a history of gastric cancer . this open-label , single-center , randomized controlled trial was conducted to investigate the appropriate timing of eradication for patients undergoing gastrectomy . one hundred and fifty patients scheduled to undergo gastrectomy were allocated to either a preoperative or a postoperative group . the eradication regimen was a common triple therapy : lansoprazole , amoxicillin , and clarithromycin . patients in the preoperative group were treated with the regimen , followed by surgery , and patients in the postoperative group were treated after postoperative day @ . the primary end point was the proportion of patients achieving successful eradication in the remnant stomach . the definition of successful eradication was negativity in both the c@ urea breath test and for the antigen in feces at @ months after surgery . eight patients were excluded , and the remaining one hundred and forty-two , @ in the preoperative group and @ in the postoperative group , were included on an intention to treat basis . the procedures used were gastrectomy with billroth i , roux-en-y , and pylorus-preserving gastrectomy in @ , @ , and @ patients , respectively . the proportion of patients showing successful eradication hardly differed between the @ groups , @ % vs @ % ( p = @ ) in the pre - and postoperative groups , respectively . subgroup analysis also demonstrated no significant difference among the reconstruction methods used . preoperative h pylori eradication therapy for gastric cancer patients scheduled for gastrectomy is not necessary , regardless of the planned reconstruction procedure .
26,141,464
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "although there has been growing evidence for the efficacy of mindfulness-based cognitive therapy ( mbct ) for different clinical populations , its effectiveness as a public mental health intervention has not been studied .", "the present study evaluates a community-based mbct intervention for adults with mild to moderate depressive symptomatology in a large multi-site , pragmatic randomized controlled trial .", "the participants with mild to moderate depressive symptomatology were recruited from the general population and randomized to the mbct intervention ( n = @ ) or to a waiting list control group ( n = @ ) .", "participants completed measures before and after the intervention .", "participants in the experimental condition also completed these measures at a @-month follow-up .", "in the experimental condition significant reductions in depression , anxiety , and experiential avoidance , and improvements in mindfulness and emotional - and psychological mental health were found , compared to the waiting list ( effect sizes cohen 's d = @-@ @ ) .", "these effects were sustained at the @-month follow-up .", "the likelihood of a clinically significant change in depressive symptoms was significantly higher for the mbct group -lsb- odds ratio ( or ) @ , p < @ at post-treatment ; nnt = @ -rsb- .", "mbct as a public mental health intervention for adults with mild to moderate depressive symptoms seems effective and applicable in a natural setting .", "nederlands trial register ntr@ ." ]
although there has been growing evidence for the efficacy of mindfulness-based cognitive therapy ( mbct ) for different clinical populations , its effectiveness as a public mental health intervention has not been studied . the present study evaluates a community-based mbct intervention for adults with mild to moderate depressive symptomatology in a large multi-site , pragmatic randomized controlled trial . the participants with mild to moderate depressive symptomatology were recruited from the general population and randomized to the mbct intervention ( n = @ ) or to a waiting list control group ( n = @ ) . participants completed measures before and after the intervention . participants in the experimental condition also completed these measures at a @-month follow-up . in the experimental condition significant reductions in depression , anxiety , and experiential avoidance , and improvements in mindfulness and emotional - and psychological mental health were found , compared to the waiting list ( effect sizes cohen 's d = @-@ @ ) . these effects were sustained at the @-month follow-up . the likelihood of a clinically significant change in depressive symptoms was significantly higher for the mbct group -lsb- odds ratio ( or ) @ , p < @ at post-treatment ; nnt = @ -rsb- . mbct as a public mental health intervention for adults with mild to moderate depressive symptoms seems effective and applicable in a natural setting . nederlands trial register ntr@ .
25,333,885
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to determine whether acute migraine treatment outcome is different in migraine with aura compared with migraine without aura .", "we examined pooled outcome data for sumatriptan treatment of migraine with and without aura from the sumatriptan/naratriptan aggregate patient database .", "we also examined similar outcome data for inhaled dihydroergotamine ( dhe ) from a single , large randomized controlled study .", "the pooled pain-free rates @ hours postdose for sumatriptan @ mg were significantly higher in patients treating attacks without aura ( @ % ) compared with the group who treated attacks with aura ( @ % ) ( p < @ ) .", "the relative risk for pain freedom @ hours postdose for attacks without aura was @ ( @ % confidence interval : @-@ @ ) .", "the number needed to treat for @ hours of pain freedom was @ for attacks without aura and @ for attacks with aura .", "for the clinical trial of dhe , the @-hour pain-free rates did not differ between patients treating attacks without aura ( @ % ) compared with those who treated attacks with aura ( @ % ; p = @ ) .", "the relative risk for pain freedom @ hours postdose for attacks without aura vs with aura was @ ( @ % confidence interval : @-@ @ ) .", "the number needed to treat for @ hours pain free was @ for attacks without aura and @ for attacks with aura .", "this post hoc analysis of pooled data from multiple randomized trials indicates that sumatriptan is less effective as acute therapy for migraine attacks with aura compared with attacks without aura .", "in the single study of inhaled dhe , the treatment had similar efficacy for migraine attacks with and without aura .", "different responses of migraine with vs without aura to acute therapies may provide insight into underlying migraine mechanisms and influence the choice of acute therapies for different types of migraine attacks ." ]
to determine whether acute migraine treatment outcome is different in migraine with aura compared with migraine without aura . we examined pooled outcome data for sumatriptan treatment of migraine with and without aura from the sumatriptan/naratriptan aggregate patient database . we also examined similar outcome data for inhaled dihydroergotamine ( dhe ) from a single , large randomized controlled study . the pooled pain-free rates @ hours postdose for sumatriptan @ mg were significantly higher in patients treating attacks without aura ( @ % ) compared with the group who treated attacks with aura ( @ % ) ( p < @ ) . the relative risk for pain freedom @ hours postdose for attacks without aura was @ ( @ % confidence interval : @-@ @ ) . the number needed to treat for @ hours of pain freedom was @ for attacks without aura and @ for attacks with aura . for the clinical trial of dhe , the @-hour pain-free rates did not differ between patients treating attacks without aura ( @ % ) compared with those who treated attacks with aura ( @ % ; p = @ ) . the relative risk for pain freedom @ hours postdose for attacks without aura vs with aura was @ ( @ % confidence interval : @-@ @ ) . the number needed to treat for @ hours pain free was @ for attacks without aura and @ for attacks with aura . this post hoc analysis of pooled data from multiple randomized trials indicates that sumatriptan is less effective as acute therapy for migraine attacks with aura compared with attacks without aura . in the single study of inhaled dhe , the treatment had similar efficacy for migraine attacks with and without aura . different responses of migraine with vs without aura to acute therapies may provide insight into underlying migraine mechanisms and influence the choice of acute therapies for different types of migraine attacks .
25,841,032
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly .", "we evaluated the immunogenicity , safety and clinical effectiveness of an mf@ ( ) - adjuvanted trivalent influenza vaccine ( ativ ) compared with a non-adjuvanted vaccine ( tiv ) in subjects @ years old , with or without co-morbidities .", "in @-@ , subjects ( n = @ ) were randomized to receive one dose of ativ or tiv .", "co-primary objectives were to assess lot-to-lot consistency of ativ , non-inferiority , superiority and immunogenicity @ days after vaccination .", "clinical effectiveness , reactogenicity and serious adverse events were monitored up to day @ .", "the immunological equivalence of three lots of ativ was demonstrated .", "ativ was not only non-inferior to tiv but also elicited significantly higher antibody responses at day @ than tiv against all homologous and heterologous strains , even in subjects with co-morbidities .", "superiority was not established .", "reactogenicity was higher in the ativ group , but reactions were mild to moderate and transient .", "ativ elicited a significantly higher antibody response than tiv , especially against a/h@n@ strains , although superiority by pre-defined criteria was not formally met .", "the study demonstrates potential immunological benefits of mf@-adjuvanted influenza vaccines for the elderly .", "this trial was registered with www.clinicaltrials.gov ( nct@ ) ." ]
adjuvanted influenza vaccines can overcome the poor antibody response of conventional non-adjuvanted vaccines in the elderly . we evaluated the immunogenicity , safety and clinical effectiveness of an mf@ ( ) - adjuvanted trivalent influenza vaccine ( ativ ) compared with a non-adjuvanted vaccine ( tiv ) in subjects @ years old , with or without co-morbidities . in @-@ , subjects ( n = @ ) were randomized to receive one dose of ativ or tiv . co-primary objectives were to assess lot-to-lot consistency of ativ , non-inferiority , superiority and immunogenicity @ days after vaccination . clinical effectiveness , reactogenicity and serious adverse events were monitored up to day @ . the immunological equivalence of three lots of ativ was demonstrated . ativ was not only non-inferior to tiv but also elicited significantly higher antibody responses at day @ than tiv against all homologous and heterologous strains , even in subjects with co-morbidities . superiority was not established . reactogenicity was higher in the ativ group , but reactions were mild to moderate and transient . ativ elicited a significantly higher antibody response than tiv , especially against a/h@n@ strains , although superiority by pre-defined criteria was not formally met . the study demonstrates potential immunological benefits of mf@-adjuvanted influenza vaccines for the elderly . this trial was registered with www.clinicaltrials.gov ( nct@ ) .
25,045,825
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "enhancing physical activity in overweight and obese individuals is an important means to promote health in this target population .", "the health action process approach ( hapa ) , which was the theoretical framework of this study , focuses on individual self-regulation variables for successful health behavior change .", "one key self-regulation variable of this model is action control with its three subfacets awareness of intentions , self-monitoring and regulatory effort .", "the social context of individuals , however , is usually neglected in common health behavior change theories .", "in order to integrate social influences into the hapa , this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity .", "this protocol describes the design of a single-blind randomized controlled trial , which comprises four experimental groups : a dyadic action control group , an individual action control group and two control groups .", "participants of this study are overweight or obese , heterosexual adult couples who intend to increase their physical activity .", "blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition .", "the ecological momentary intervention takes place in the first @ days after baseline assessment and is followed by another @ days diary phase without intervention .", "follow-ups are one month and six months later .", "subsequent to the six-months follow-up another @ days diary phase takes place.the main outcome measures are self-reported and accelerometer-assessed physical activity .", "secondary outcome measures are body mass index ( bmi ) , aerobic fitness and habitual physical activity .", "this is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial .", "challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed .", "this rct was funded by the swiss national science foundation ( pp@p@_@ / @ ) and was registered on @/@/@ at http://www.isrctn.com/isrctn@ ." ]
enhancing physical activity in overweight and obese individuals is an important means to promote health in this target population . the health action process approach ( hapa ) , which was the theoretical framework of this study , focuses on individual self-regulation variables for successful health behavior change . one key self-regulation variable of this model is action control with its three subfacets awareness of intentions , self-monitoring and regulatory effort . the social context of individuals , however , is usually neglected in common health behavior change theories . in order to integrate social influences into the hapa , this randomized controlled trial investigated the effectiveness of a dyadic conceptualization of action control for promoting physical activity . this protocol describes the design of a single-blind randomized controlled trial , which comprises four experimental groups : a dyadic action control group , an individual action control group and two control groups . participants of this study are overweight or obese , heterosexual adult couples who intend to increase their physical activity . blocking as means of a gender-balanced randomization is used to allocate couples to conditions and partners to either being the target person of the intervention or to the partner condition . the ecological momentary intervention takes place in the first @ days after baseline assessment and is followed by another @ days diary phase without intervention . follow-ups are one month and six months later . subsequent to the six-months follow-up another @ days diary phase takes place.the main outcome measures are self-reported and accelerometer-assessed physical activity . secondary outcome measures are body mass index ( bmi ) , aerobic fitness and habitual physical activity . this is the first study examining a dyadic action control intervention in comparison to an individual action control condition and two control groups applying a single-blind randomized control trial . challenges with running couples studies as well as advantages and disadvantages of certain design-related decisions are discussed . this rct was funded by the swiss national science foundation ( pp@p@_@ / @ ) and was registered on @/@/@ at http://www.isrctn.com/isrctn@ .
25,540,972
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "we sought to examine changes in intraocular pressure ( iop ) in the immediate period after clear corneal micro-incision cataract surgery ( mics ) and after small-incision cataract surgery ( sics ) .", "sixty-eight eyes of @ patients scheduled for coaxial phacoemulsification were randomized into one of two groups : ( a ) eyes that were to undergo a @-mm mics , and ( b ) a @-mm sics .", "at the conclusion of surgery , the iop was adjusted to the range between @-@mmhg with stromal hydration .", "the iop was measured using a rebound tonometer preoperatively , at the conclusion of surgery , and at @ , @ , @ , @ , and @min postoperatively .", "the seidel test and anterior segment-optical coherence tomography were performed at @min postoperatively .", "mean iop at the conclusion of surgery was @ mmhg in the mics group and @ mmhg in the sics group ( p = @ ) .", "in both groups , mean iop decreased to the preoperative level within @min postoperatively and did not change significantly for up to @min .", "mean iop was similar between the mics and sics groups throughout the observation period ( p@ @ ) .", "hypotony ( @mmhg ) , positive seidel test , and loss of wound coaptation were not detected in all eyes .", "after adjusting the iop to a relatively high level at the conclusion of surgery , the iop decreased within @min and was stable within @min without hypotony .", "the iop was comparable between eyes after mics and sics , and both incisions virtually closed within @min postoperatively ." ]
we sought to examine changes in intraocular pressure ( iop ) in the immediate period after clear corneal micro-incision cataract surgery ( mics ) and after small-incision cataract surgery ( sics ) . sixty-eight eyes of @ patients scheduled for coaxial phacoemulsification were randomized into one of two groups : ( a ) eyes that were to undergo a @-mm mics , and ( b ) a @-mm sics . at the conclusion of surgery , the iop was adjusted to the range between @-@mmhg with stromal hydration . the iop was measured using a rebound tonometer preoperatively , at the conclusion of surgery , and at @ , @ , @ , @ , and @min postoperatively . the seidel test and anterior segment-optical coherence tomography were performed at @min postoperatively . mean iop at the conclusion of surgery was @ mmhg in the mics group and @ mmhg in the sics group ( p = @ ) . in both groups , mean iop decreased to the preoperative level within @min postoperatively and did not change significantly for up to @min . mean iop was similar between the mics and sics groups throughout the observation period ( p@ @ ) . hypotony ( @mmhg ) , positive seidel test , and loss of wound coaptation were not detected in all eyes . after adjusting the iop to a relatively high level at the conclusion of surgery , the iop decreased within @min and was stable within @min without hypotony . the iop was comparable between eyes after mics and sics , and both incisions virtually closed within @min postoperatively .
24,969,339
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "buprenorphine/naloxone ( bup/nx ) , an effective treatment for opioid dependence , has been implicated in hepatic toxicity .", "however , as persons taking bup/nx have multiple hepatic risk factors , comparative data are needed to quantify the risk of hepatoxicity with bup/nx .", "we compared rates of alanine aminotransferase ( alt ) elevationgrade @ ( alt@ @ times the upper limit of normal ) and graded bilirubin elevations in hiv-negative opioid injectors randomized to long-term ( @ weeks ) or short-term ( @ days ) medication assisted treatment ( lt-mat and st-mat , respectively ) with bup/nx in a multisite trial conducted in china and thailand .", "alt and bilirubin were measured at baseline , @ , @ , @ and @ weeks , times temporally remote from bup/nx exposure in the st-mat participants .", "among@ subjects with at least one laboratory follow-up measurement , @ ( @ % ) participants experienced alt elevationgrade @ .", "in an intent-to-treat analysis , the risk of alt events was similar in participants randomized to lt-mat compared with st-mat ( adjusted hazard ratio @ , @ % confidence interval @ to @ ) .", "this finding was supported by an as-treated analysis , in which actual exposure to bup/nx was considered .", "hepatitis c seroconversion during follow-up was strongly associated with alt events .", "bilirubin elevationsgrade @ occurred in @ % of subjects , with no significant difference between arms .", "over @-week follow-up , the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with bup/nx .", "these data suggest that most hepatotoxic events observed during treatment with bup/nx are due to other factors ." ]
buprenorphine/naloxone ( bup/nx ) , an effective treatment for opioid dependence , has been implicated in hepatic toxicity . however , as persons taking bup/nx have multiple hepatic risk factors , comparative data are needed to quantify the risk of hepatoxicity with bup/nx . we compared rates of alanine aminotransferase ( alt ) elevationgrade @ ( alt@ @ times the upper limit of normal ) and graded bilirubin elevations in hiv-negative opioid injectors randomized to long-term ( @ weeks ) or short-term ( @ days ) medication assisted treatment ( lt-mat and st-mat , respectively ) with bup/nx in a multisite trial conducted in china and thailand . alt and bilirubin were measured at baseline , @ , @ , @ and @ weeks , times temporally remote from bup/nx exposure in the st-mat participants . among@ subjects with at least one laboratory follow-up measurement , @ ( @ % ) participants experienced alt elevationgrade @ . in an intent-to-treat analysis , the risk of alt events was similar in participants randomized to lt-mat compared with st-mat ( adjusted hazard ratio @ , @ % confidence interval @ to @ ) . this finding was supported by an as-treated analysis , in which actual exposure to bup/nx was considered . hepatitis c seroconversion during follow-up was strongly associated with alt events . bilirubin elevationsgrade @ occurred in @ % of subjects , with no significant difference between arms . over @-week follow-up , the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with bup/nx . these data suggest that most hepatotoxic events observed during treatment with bup/nx are due to other factors .
24,999,060
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "patients with type @ diabetes face heightened risk of hypoglycemia after exercise .", "subsequent overfeeding , as a preventative measure against hypoglycemia , negates the energy deficit after exercise .", "patients are also required to reduce the insulin dose administered with postexercise foods to further combat hypoglycemia .", "however , the insulin dose is dictated solely by the carbohydrate content , even though postprandial glycemia is vastly influenced by glycemic index ( gi ) .", "with a need to control the postexercise energy balance , appetite responses after meals differing in gi are of particular interest .", "we assessed the appetite response to low-glycemic index ( lgi ) and high-glycemic index ( hgi ) postexercise meals in type @ diabetes patients .", "this assessment also offered us the opportunity to evaluate the influence of gi on appetite responses independently of insulinemia , which confounds findings in individuals without diabetes .", "ten physically active men with type @ diabetes completed @ trials in a randomized crossover design .", "after @ min of treadmill exercise at @ % of the peak oxygen uptake , participants consumed an lgi ( gi @ ) or hgi ( gi @ ) meal with a matched macronutrient composition , negligible fiber content , and standardized insulin-dose administration .", "the postprandial appetite response was determined for @ min postmeal .", "during this time , circulating glucose , insulin , glucagon , and glucagon-like peptide-@ ( glp-@ ) concentrations and subjective appetite ratings were determined .", "the hgi meal produced an @ % greater postprandial glucose area under the curve ( auc ) than did the lgi meal ( p = @ ) .", "insulin , glucagon , and glp-@ did not significantly differ between trials ( p > @ ) .", "the fullness auc was @ % greater after the hgi meal than after the lgi meal ( p < @ ) , whereas hunger sensations were @ % lower after the hgi meal than after the lgi meal ( p = @ ) .", "under conditions of matched insulinemia and fiber , an hgi postexercise meal suppresses feelings of hunger and augments postprandial fullness sensations more so than an otherwise equivalent lgi meal in type @ diabetes patients ." ]
patients with type @ diabetes face heightened risk of hypoglycemia after exercise . subsequent overfeeding , as a preventative measure against hypoglycemia , negates the energy deficit after exercise . patients are also required to reduce the insulin dose administered with postexercise foods to further combat hypoglycemia . however , the insulin dose is dictated solely by the carbohydrate content , even though postprandial glycemia is vastly influenced by glycemic index ( gi ) . with a need to control the postexercise energy balance , appetite responses after meals differing in gi are of particular interest . we assessed the appetite response to low-glycemic index ( lgi ) and high-glycemic index ( hgi ) postexercise meals in type @ diabetes patients . this assessment also offered us the opportunity to evaluate the influence of gi on appetite responses independently of insulinemia , which confounds findings in individuals without diabetes . ten physically active men with type @ diabetes completed @ trials in a randomized crossover design . after @ min of treadmill exercise at @ % of the peak oxygen uptake , participants consumed an lgi ( gi @ ) or hgi ( gi @ ) meal with a matched macronutrient composition , negligible fiber content , and standardized insulin-dose administration . the postprandial appetite response was determined for @ min postmeal . during this time , circulating glucose , insulin , glucagon , and glucagon-like peptide-@ ( glp-@ ) concentrations and subjective appetite ratings were determined . the hgi meal produced an @ % greater postprandial glucose area under the curve ( auc ) than did the lgi meal ( p = @ ) . insulin , glucagon , and glp-@ did not significantly differ between trials ( p > @ ) . the fullness auc was @ % greater after the hgi meal than after the lgi meal ( p < @ ) , whereas hunger sensations were @ % lower after the hgi meal than after the lgi meal ( p = @ ) . under conditions of matched insulinemia and fiber , an hgi postexercise meal suppresses feelings of hunger and augments postprandial fullness sensations more so than an otherwise equivalent lgi meal in type @ diabetes patients .
25,733,632
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this study sought to evaluate the prognostic value of routine stress myocardial perfusion scintigraphy ( mps ) @ years after percutaneous coronary intervention ( pci ) .", "current appropriate use criteria define routine cardiac stress imaging < @ years after pci as inappropriate and > @ years as uncertain in asymptomatic patients .", "all @ of @ basket ( basel stent kosteneffektivitts trial ) @-year survivors ( @ % ) consenting to undergo protocol-mandated mps and subsequent evaluation irrespective of symptoms were followed for major adverse cardiac events ( mace ) ( cardiac death , myocardial infarction -lsb- mi -rsb- , or revascularization ) .", "for mps , summed perfusion scores were calculated and perfusion defects were related to treated-vessel or remote myocardial areas .", "patients were @ @ years of age , @ % were female , and @ % were free of angina .", "mps findings were abnormal in @ of @ patients ( @ % ) with complete follow-up .", "during @ @ years , there were @ cardiac deaths , @ mis , and @ revascularizations , resulting in a mace rate of @ % and a cardiac mortality rate of @ % per year .", "patients with abnormal mps findings had higher hazard ratios ( hr ) for mace ( hr : @ ; @ % confidence interval -lsb- ci -rsb- : @ to @ ; p = @ ) , and cardiac death/mi ( hr : @ ; @ % ci : @ to @ ; p = @ ) than patients with normal mps finding .", "mace rates were similar in patients with symptomatic and silent ischemia ( p = @ ) but higher than in patients with normal mps findings ( p < @ for both comparisons ) .", "mace rates were independently predicted by remote ischemia but not by treated-vessel ischemia or scar .", "abnormal mps findings @ years after pci are frequent irrespective of symptoms .", "the predictive power of abnormal mps lies more in the detection of persistent or progressing coronary artery disease in remote vessel areas than in the diagnosis of late intervention-related problems in treated vessels ." ]
this study sought to evaluate the prognostic value of routine stress myocardial perfusion scintigraphy ( mps ) @ years after percutaneous coronary intervention ( pci ) . current appropriate use criteria define routine cardiac stress imaging < @ years after pci as inappropriate and > @ years as uncertain in asymptomatic patients . all @ of @ basket ( basel stent kosteneffektivitts trial ) @-year survivors ( @ % ) consenting to undergo protocol-mandated mps and subsequent evaluation irrespective of symptoms were followed for major adverse cardiac events ( mace ) ( cardiac death , myocardial infarction -lsb- mi -rsb- , or revascularization ) . for mps , summed perfusion scores were calculated and perfusion defects were related to treated-vessel or remote myocardial areas . patients were @ @ years of age , @ % were female , and @ % were free of angina . mps findings were abnormal in @ of @ patients ( @ % ) with complete follow-up . during @ @ years , there were @ cardiac deaths , @ mis , and @ revascularizations , resulting in a mace rate of @ % and a cardiac mortality rate of @ % per year . patients with abnormal mps findings had higher hazard ratios ( hr ) for mace ( hr : @ ; @ % confidence interval -lsb- ci -rsb- : @ to @ ; p = @ ) , and cardiac death/mi ( hr : @ ; @ % ci : @ to @ ; p = @ ) than patients with normal mps finding . mace rates were similar in patients with symptomatic and silent ischemia ( p = @ ) but higher than in patients with normal mps findings ( p < @ for both comparisons ) . mace rates were independently predicted by remote ischemia but not by treated-vessel ischemia or scar . abnormal mps findings @ years after pci are frequent irrespective of symptoms . the predictive power of abnormal mps lies more in the detection of persistent or progressing coronary artery disease in remote vessel areas than in the diagnosis of late intervention-related problems in treated vessels .
24,835,324
[ "OBJECTIVE", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "patients with posttraumatic stress disorder ( ptsd ) have significant medical morbidity , which may be mediated by hypothalamic pituitary axis ( hpa ) dysfunction and reflected in cortisol output .", "many veterans with ptsd are hesitant to engage in trauma-focused exposure treatments ; therefore briefer , non-exposure-based treatments are needed ; one such promising approach is an abbreviated primary care brief mindfulness program ( pcbmp ) .", "this study investigated the relationship between dose-response to participation in a veterans pcbmp program and diurnal cortisol .", "cortisol reflects hpa function and ptsd is associated with hpa dysregulation .", "veterans with ptsd were identified in pc and randomly assigned to treatment as usual ( tau , n = @ ) or participation in brief @-week mindfulness based stress reduction program ( n = @ ) .", "veterans ( n = @ ) ( mean age , @ y ; @ % men ) with ptsd referred through their va pc provider and randomly assigned to pcbmp or tau .", "as an objective indicator of hpa function , salivary diurnal cortisol was measured from samples collected across @ consecutive days at baseline and follow-up .", "analyses revealed that significant changes in cortisol were associated with pcbmp treatment engagement and dosing ( number of mindfulness program sessions completed ) .", "veterans completing @ mindfulness-based meditation sessions significantly reduced their cortisol awakening response ( p@ @ ) ; and had significant changes in cortisol area under the curve increase compared with tau participants ( p@ @ ) .", "results indicate that pcbmp has a beneficial physiological impact on veterans with ptsd with a minimum of @ weeks of practice ." ]
patients with posttraumatic stress disorder ( ptsd ) have significant medical morbidity , which may be mediated by hypothalamic pituitary axis ( hpa ) dysfunction and reflected in cortisol output . many veterans with ptsd are hesitant to engage in trauma-focused exposure treatments ; therefore briefer , non-exposure-based treatments are needed ; one such promising approach is an abbreviated primary care brief mindfulness program ( pcbmp ) . this study investigated the relationship between dose-response to participation in a veterans pcbmp program and diurnal cortisol . cortisol reflects hpa function and ptsd is associated with hpa dysregulation . veterans with ptsd were identified in pc and randomly assigned to treatment as usual ( tau , n = @ ) or participation in brief @-week mindfulness based stress reduction program ( n = @ ) . veterans ( n = @ ) ( mean age , @ y ; @ % men ) with ptsd referred through their va pc provider and randomly assigned to pcbmp or tau . as an objective indicator of hpa function , salivary diurnal cortisol was measured from samples collected across @ consecutive days at baseline and follow-up . analyses revealed that significant changes in cortisol were associated with pcbmp treatment engagement and dosing ( number of mindfulness program sessions completed ) . veterans completing @ mindfulness-based meditation sessions significantly reduced their cortisol awakening response ( p@ @ ) ; and had significant changes in cortisol area under the curve increase compared with tau participants ( p@ @ ) . results indicate that pcbmp has a beneficial physiological impact on veterans with ptsd with a minimum of @ weeks of practice .
25,397,819
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS" ]
[ "to compare intraocular pressure ( iop ) measurements with the goldmann applanation tonometer ( gat ) and the icare rebound tonometer ( rbt ) in high myopic eyes .", "this randomized prospective study included @ eyes of @ patients with high myopia .", "all patients ' central corneal thickness ( cct ) , anterior chamber depth ( acd ) , axial length ( axl ) , keratometry , and refractive measurements were recorded and followed by iop measurement with rbt and gat .", "the average cct , axl , and acd were determined to be @ @ m , @ @ mm , and @ @ mm , respectively .", "mean k was @ @ d and mean spherical equivalent was -@ @ d.", "the mean iop values obtained by rbt and gat were @ @ mmhg and @ @ mmhg , respectively .", "the deviations of rbt readings from corrected gat values were highly correlated with cct values ( r = @ , p = @ ) .", "the mean corrected gat reading was @ @ mmhg .", "linear regression analysis showed that a cct change of @ m resulted in an rbt reading deviation of @ mmhg .", "the bland-altman scatter-plot and mcnemar test showed a clinically good level of agreement between the two tonometers .", "this study found a good agreement level between the two tonometers in high myopic patients and that rbt measurements are influenced by cct variations ." ]
to compare intraocular pressure ( iop ) measurements with the goldmann applanation tonometer ( gat ) and the icare rebound tonometer ( rbt ) in high myopic eyes . this randomized prospective study included @ eyes of @ patients with high myopia . all patients ' central corneal thickness ( cct ) , anterior chamber depth ( acd ) , axial length ( axl ) , keratometry , and refractive measurements were recorded and followed by iop measurement with rbt and gat . the average cct , axl , and acd were determined to be @ @ m , @ @ mm , and @ @ mm , respectively . mean k was @ @ d and mean spherical equivalent was -@ @ d. the mean iop values obtained by rbt and gat were @ @ mmhg and @ @ mmhg , respectively . the deviations of rbt readings from corrected gat values were highly correlated with cct values ( r = @ , p = @ ) . the mean corrected gat reading was @ @ mmhg . linear regression analysis showed that a cct change of @ m resulted in an rbt reading deviation of @ mmhg . the bland-altman scatter-plot and mcnemar test showed a clinically good level of agreement between the two tonometers . this study found a good agreement level between the two tonometers in high myopic patients and that rbt measurements are influenced by cct variations .
25,379,549
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to explore the clinical effectiveness of continuous blood purification ( cbp ) in combination with ulinastatin for the treatment of thermoplegia .", "forty patients ( @ men and @ women ) with severe heat stroke were admitted to our hospital 's icu department from june @ to august @ .", "the patients were randomized into a treatment group ( n = @ ; @ men and six women , with an average age of @ years ) and control group ( n = @ ; @ men and six women , with an average age of @ years ) .", "patients in the control group underwent treatments of oxygen inhalation , dynamic ecg monitoring , physical cooling methods ( ice caps or ice application ) , whereas patients in the treatment group , in addition to this treatment , were further treated with continuous blood purification in combination with ulinastatin .", "during administration , the content of one vial was dissolved in @ ml of physiological saline for intravenous dripping for @ hours .", "there were @ cured cases , one case of sequelae of mild neurological disorders , and two deaths in the treatment group , with the cure rate of @ % .", "in comparison , there were @ cured cases , three cases of sequelae of mild neurological disorders , and four deaths in the control group , with the cure rate of @ % .", "the overall response rates of rectal temperature drop were determined to be @ % and @ % for the treatment group and the control group , respectively .", "based on the treatment outcomes data , multiple organ dysfunction syndrome ( mods ) recovery , deaths and survival outcomes of patients in the treatment group was more favorable than that of the control group .", "this difference was statistically significant ( p < @ ) .", "continuous blood purification in combination with ulinastatin is effective in treating thermoplegia and warrants further investigation ." ]
to explore the clinical effectiveness of continuous blood purification ( cbp ) in combination with ulinastatin for the treatment of thermoplegia . forty patients ( @ men and @ women ) with severe heat stroke were admitted to our hospital 's icu department from june @ to august @ . the patients were randomized into a treatment group ( n = @ ; @ men and six women , with an average age of @ years ) and control group ( n = @ ; @ men and six women , with an average age of @ years ) . patients in the control group underwent treatments of oxygen inhalation , dynamic ecg monitoring , physical cooling methods ( ice caps or ice application ) , whereas patients in the treatment group , in addition to this treatment , were further treated with continuous blood purification in combination with ulinastatin . during administration , the content of one vial was dissolved in @ ml of physiological saline for intravenous dripping for @ hours . there were @ cured cases , one case of sequelae of mild neurological disorders , and two deaths in the treatment group , with the cure rate of @ % . in comparison , there were @ cured cases , three cases of sequelae of mild neurological disorders , and four deaths in the control group , with the cure rate of @ % . the overall response rates of rectal temperature drop were determined to be @ % and @ % for the treatment group and the control group , respectively . based on the treatment outcomes data , multiple organ dysfunction syndrome ( mods ) recovery , deaths and survival outcomes of patients in the treatment group was more favorable than that of the control group . this difference was statistically significant ( p < @ ) . continuous blood purification in combination with ulinastatin is effective in treating thermoplegia and warrants further investigation .
25,491,622
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the potential for telehealth-based interventions to provide remote support , education and improve self-management for long-term conditions is increasingly recognised .", "this trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease ( copd ) by providing personalised self-management information and education .", "the edge ( self management and support programme ) for copd is a multicentre , randomised controlled trial designed to assess the efficacy of an internet-linked tablet computer-based intervention ( the edge platform ) in improving quality of life in patients with moderate to very severe copd compared with usual care .", "eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a @:@ ratio using a web-based randomisation system .", "participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a copd-related admission and from primary care clinics .", "participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a bluetooth-linked pulse oximeter .", "participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables .", "the primary outcome of quality of life is measured using the st george 's respiratory questionnaire for copd patients ( sgrq-c ) baseline , @ and @ months .", "secondary outcome measures are recorded at these intervals in addition to @ months .", "the research ethics committee for berkshire-south central has provided ethical approval for the conduct of the study in the recruiting regions .", "the results of the study will be disseminated through peer review publications and conference presentations .", "current controlled trials isrctn@ ." ]
the potential for telehealth-based interventions to provide remote support , education and improve self-management for long-term conditions is increasingly recognised . this trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease ( copd ) by providing personalised self-management information and education . the edge ( self management and support programme ) for copd is a multicentre , randomised controlled trial designed to assess the efficacy of an internet-linked tablet computer-based intervention ( the edge platform ) in improving quality of life in patients with moderate to very severe copd compared with usual care . eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a @:@ ratio using a web-based randomisation system . participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a copd-related admission and from primary care clinics . participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a bluetooth-linked pulse oximeter . participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables . the primary outcome of quality of life is measured using the st george 's respiratory questionnaire for copd patients ( sgrq-c ) baseline , @ and @ months . secondary outcome measures are recorded at these intervals in addition to @ months . the research ethics committee for berkshire-south central has provided ethical approval for the conduct of the study in the recruiting regions . the results of the study will be disseminated through peer review publications and conference presentations . current controlled trials isrctn@ .
24,401,729
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]
[ "to evaluate the efficacy and safety of human glucagon-like peptide-@ analogue liraglutide in newly diagnosed type @ diabetes mellitus ( t@dm ) with glycosylated hemoglobin a@c ( hba@c ) > @ % .", "this was an open-labelled , randomized , parallel-group , treat-to-target trial .", "newly diagnosed t@dm patients with hba@c > @ % were enrolled .", "these patients were treated with metformin with repaglinide and randomized to receive once-daily liraglutide ( lira , n = @ ) or the insulin glargine ( igla , n = @ ) at bedtime .", "efficacy and safety were assessed and compared after @-month treatment .", "( @ ) compared with the baseline , patients with lira had significantly reduced mean body weight , bmi and waist circumference ( p < @ ) , whereas , the above indexes were increased ( p < @ ) in patients treated with igla .", "( @ ) after @ months of treatment , fasting plasma glucose ( fpg ) , @-hour plasma glucose after a @g oral glucose load ( @hpg ) and hba@c were significantly improved in all patients ( p < @ ) , with @hpg , mean blood glucose ( mbg ) , the largest amplitude of glycemic excursions ( lage ) , mean amplitude of glycemic excursions ( mage ) were significantly lower in lira group than in igla group ( all p < @ ) .", "( @ ) homa-ir decreased in both groups ( p < @ ) .", "however , i@/g@ , auccp@ and matsuda index were only significantly increased in patients treated with lira ( respectively , @ @ vs @ , @ @ vs @ @ , @ @ vs @ @ , all p < @ ) , while homa-ir reduced ( @ @ vs @ @ , p < @ ) .", "but in igla group only homa-ir was reduced ( @ @ vs @ @ , p < @ ) .", "the index of i@/g@ , auccp@ and matsuda index in lira group are higher than those of indexes in igla group ( respectively , @ @ vs @ @ , @ @ vs @ @,@ @ vs @ @ , all p < @ ) , while homa-ir is lower ( @ @ vs @ @ , p < @ ) .", "( @ ) the rate of hba@c @ % and the dosages of oral anti-diabetic drugs in lira group were significantly better than that in igla group .", "( @ ) no significant differences were observed in hypoglycemic episodes and adverse events between two groups .", "it seems that liraglutide is superior to insulin glargine in newly diagnosed t@dm patients with hba@c > @ % in improving beta-cell function , insulin sensitivity and glucose homeostasis ." ]
to evaluate the efficacy and safety of human glucagon-like peptide-@ analogue liraglutide in newly diagnosed type @ diabetes mellitus ( t@dm ) with glycosylated hemoglobin a@c ( hba@c ) > @ % . this was an open-labelled , randomized , parallel-group , treat-to-target trial . newly diagnosed t@dm patients with hba@c > @ % were enrolled . these patients were treated with metformin with repaglinide and randomized to receive once-daily liraglutide ( lira , n = @ ) or the insulin glargine ( igla , n = @ ) at bedtime . efficacy and safety were assessed and compared after @-month treatment . ( @ ) compared with the baseline , patients with lira had significantly reduced mean body weight , bmi and waist circumference ( p < @ ) , whereas , the above indexes were increased ( p < @ ) in patients treated with igla . ( @ ) after @ months of treatment , fasting plasma glucose ( fpg ) , @-hour plasma glucose after a @g oral glucose load ( @hpg ) and hba@c were significantly improved in all patients ( p < @ ) , with @hpg , mean blood glucose ( mbg ) , the largest amplitude of glycemic excursions ( lage ) , mean amplitude of glycemic excursions ( mage ) were significantly lower in lira group than in igla group ( all p < @ ) . ( @ ) homa-ir decreased in both groups ( p < @ ) . however , i@/g@ , auccp@ and matsuda index were only significantly increased in patients treated with lira ( respectively , @ @ vs @ , @ @ vs @ @ , @ @ vs @ @ , all p < @ ) , while homa-ir reduced ( @ @ vs @ @ , p < @ ) . but in igla group only homa-ir was reduced ( @ @ vs @ @ , p < @ ) . the index of i@/g@ , auccp@ and matsuda index in lira group are higher than those of indexes in igla group ( respectively , @ @ vs @ @ , @ @ vs @ @,@ @ vs @ @ , all p < @ ) , while homa-ir is lower ( @ @ vs @ @ , p < @ ) . ( @ ) the rate of hba@c @ % and the dosages of oral anti-diabetic drugs in lira group were significantly better than that in igla group . ( @ ) no significant differences were observed in hypoglycemic episodes and adverse events between two groups . it seems that liraglutide is superior to insulin glargine in newly diagnosed t@dm patients with hba@c > @ % in improving beta-cell function , insulin sensitivity and glucose homeostasis .
26,268,058
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this primary objective of this pilot randomized , controlled trial was to determine whether a brief video intervention delivered after a pediatric office visit could improve inhaler technique in children with asthma immediately and one month later .", "the intervention 's effect on children 's inhaler self-efficacy and asthma control was also evaluated .", "children ( n = @ ) ages @-@ years with persistent asthma were recruited at two pediatric practices in north carolina .", "eligible children demonstrated their inhaler technique for metered dose inhalers ( mdis ) either with or without a spacer .", "a trained research assistant used a validated inhaler technique checklist to record which steps children performed correctly .", "after a regularly scheduled office visit , children were randomized to watch either a @-min mdi video ( intervention group ) or a nutrition video ( control group ) in english or spanish .", "children 's technique was assessed again after watching the video and one month later .", "children were primarily male ( @ % ) and non-white ( @ % ) .", "when compared with the control group , children in the intervention group demonstrated a significant improvement in mdi technique post-intervention -lsb- mean = @ steps , @ % ci ( @ , @ ) -rsb- but the improvement was not sustained at @-month follow-up .", "the intervention did not lead to significant improvements in inhaler self-efficacy or asthma control .", "a brief video intervention offered during pediatric clinic visits can lead to immediate improvements in children 's inhaler technique .", "future studies should evaluate whether booster training videos can help maintain improvements in children 's inhaler technique over time ." ]
this primary objective of this pilot randomized , controlled trial was to determine whether a brief video intervention delivered after a pediatric office visit could improve inhaler technique in children with asthma immediately and one month later . the intervention 's effect on children 's inhaler self-efficacy and asthma control was also evaluated . children ( n = @ ) ages @-@ years with persistent asthma were recruited at two pediatric practices in north carolina . eligible children demonstrated their inhaler technique for metered dose inhalers ( mdis ) either with or without a spacer . a trained research assistant used a validated inhaler technique checklist to record which steps children performed correctly . after a regularly scheduled office visit , children were randomized to watch either a @-min mdi video ( intervention group ) or a nutrition video ( control group ) in english or spanish . children 's technique was assessed again after watching the video and one month later . children were primarily male ( @ % ) and non-white ( @ % ) . when compared with the control group , children in the intervention group demonstrated a significant improvement in mdi technique post-intervention -lsb- mean = @ steps , @ % ci ( @ , @ ) -rsb- but the improvement was not sustained at @-month follow-up . the intervention did not lead to significant improvements in inhaler self-efficacy or asthma control . a brief video intervention offered during pediatric clinic visits can lead to immediate improvements in children 's inhaler technique . future studies should evaluate whether booster training videos can help maintain improvements in children 's inhaler technique over time .
25,025,548
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "it has been reported that dexmedetomidine ( dex ) can be used for conscious sedation in awake craniotomy , but few data exist to compare dex versus propofol ( pro ) .", "to compare the efficacy and safety of dex versus pro for conscious sedation in awake craniotomy .", "thirty patients of american society of anesthesiologists grade i-ii scheduled for awake craniotomy , were randomized into @ groups each containing @ subjects .", "group d received dex and group p received pro .", "two minutes after tracheal intubation ( t@ ) , pro ( target plasma concentration ) was titrated down to @ to @ g/ml in group p.", "in group d , pro was discontinued and dex was administered @ g/kg followed by a maintenance dose of @ to @ g/kg/h .", "the surgeon preset the anticipated awake point-in-time ( t@ ) preoperatively .", "ten minutes before t@ ( t@ ) , dex was titrated down to @ g/kg/h in group d , pro was discontinued and normal saline ( placebo ) @ ml/h was infused in group p. arousal time , quality of revival and adverse events during the awake period , degree of satisfaction from surgeons and patients were recorded .", "arousal time was significantly shorter in group d than in group p ( p < @ ) .", "the quality of revival during the awake period in group d was similar to that of group p ( p = @ ) .", "the degree of satisfaction of surgeons was significantly higher in group d than in group p ( p < @ ) , but no difference was found between the @ groups with respect to patient satisfaction ( p = @ ) .", "there was no difference between the @ groups in the incidence of adverse events during the awake period ( p > @ ) .", "either dex or pro can be effectively and safely used for conscious sedation in awake craniotomy .", "comparing the two , dex produced a shorter arousal time and a higher degree of surgeon satisfaction ." ]
it has been reported that dexmedetomidine ( dex ) can be used for conscious sedation in awake craniotomy , but few data exist to compare dex versus propofol ( pro ) . to compare the efficacy and safety of dex versus pro for conscious sedation in awake craniotomy . thirty patients of american society of anesthesiologists grade i-ii scheduled for awake craniotomy , were randomized into @ groups each containing @ subjects . group d received dex and group p received pro . two minutes after tracheal intubation ( t@ ) , pro ( target plasma concentration ) was titrated down to @ to @ g/ml in group p. in group d , pro was discontinued and dex was administered @ g/kg followed by a maintenance dose of @ to @ g/kg/h . the surgeon preset the anticipated awake point-in-time ( t@ ) preoperatively . ten minutes before t@ ( t@ ) , dex was titrated down to @ g/kg/h in group d , pro was discontinued and normal saline ( placebo ) @ ml/h was infused in group p. arousal time , quality of revival and adverse events during the awake period , degree of satisfaction from surgeons and patients were recorded . arousal time was significantly shorter in group d than in group p ( p < @ ) . the quality of revival during the awake period in group d was similar to that of group p ( p = @ ) . the degree of satisfaction of surgeons was significantly higher in group d than in group p ( p < @ ) , but no difference was found between the @ groups with respect to patient satisfaction ( p = @ ) . there was no difference between the @ groups in the incidence of adverse events during the awake period ( p > @ ) . either dex or pro can be effectively and safely used for conscious sedation in awake craniotomy . comparing the two , dex produced a shorter arousal time and a higher degree of surgeon satisfaction .
24,259,599
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "in the last @ decades , the effectiveness of cricoid pressure ( cp ) in occluding the esophageal entrance has been questioned .", "recent magnetic resonance imaging studies yielded conflicting conclusions .", "we used real-time visual and mechanical means to assess the patency of the esophageal entrance with and without cp in anesthetized and paralyzed adult patients .", "one hundred seven , nonobese asa physical status i and ii patients were recruited for the study .", "a cricoid force of @ n was used .", "this force was standardized by using a weighing scale before application of cp in each patient .", "after oxygen administration , anesthetic induction , neuromuscular blockade , and establishment of manual ventilation with fio@ = @ , the view of the glottis and esophageal entrance was visualized , and video recordings were obtained by using a glidescope video laryngoscope .", "attempts to insert @ gastric tubes ( gts ) , size @ and @ f , into the esophagus were made by a `` blinded '' operator without and with cp , the timing of which was randomized .", "a successful insertion of a gt in the presence of cp was considered evidence of a patent esophageal entrance ( ineffective cp ) , whereas an unsuccessful insertion of a gt was considered evidence of an occluded esophageal entrance ( effective cp ) .", "after the attempts to insert the gts were completed , tracheal intubation was performed while cp was applied .", "the position of the esophageal entrance in relation to the glottis ( midline versus lateral ) was assessed from the video recordings , with and without cp .", "we stopped the study when @ patients ( @ men and @ women ) qualified for and completed the study ( @-sided clopper-pearson confidence interval ( ci ) @ % to @ % , n = @ ) .", "advancement of either size gt into the esophagus could not be accomplished during cp in any patient but was easily done in all subjects when cp was not applied .", "this occurred whether the esophageal entrance was in a midline position or in a left or right lateral position relative to the glottis .", "esophageal patency was visually observed in the absence of cp , whereas occlusion of the esophageal entrance was observed during cp in all patients .", "without cp , the esophageal entrance was in a left lateral position in relation to the glottis in @ % ( -lsb- @ % ci , @ % -@ % ) -rsb- of patients , at midline in @ % ( ci , @ % -@ % ) , and in a right lateral position in @ % ( ci , @ % -@ % ) .", "the position did not change with cp .", "the current study provides additional visual and mechanical evidence supporting a success rate of at least @ % by using a cricoid force of @ n to occlude the esophageal entrance in anesthetized and paralyzed normal adult patients .", "the efficacy of the maneuver was independent of the position of the esophageal entrance relative to the glottis , whether midline or lateral ." ]
in the last @ decades , the effectiveness of cricoid pressure ( cp ) in occluding the esophageal entrance has been questioned . recent magnetic resonance imaging studies yielded conflicting conclusions . we used real-time visual and mechanical means to assess the patency of the esophageal entrance with and without cp in anesthetized and paralyzed adult patients . one hundred seven , nonobese asa physical status i and ii patients were recruited for the study . a cricoid force of @ n was used . this force was standardized by using a weighing scale before application of cp in each patient . after oxygen administration , anesthetic induction , neuromuscular blockade , and establishment of manual ventilation with fio@ = @ , the view of the glottis and esophageal entrance was visualized , and video recordings were obtained by using a glidescope video laryngoscope . attempts to insert @ gastric tubes ( gts ) , size @ and @ f , into the esophagus were made by a `` blinded '' operator without and with cp , the timing of which was randomized . a successful insertion of a gt in the presence of cp was considered evidence of a patent esophageal entrance ( ineffective cp ) , whereas an unsuccessful insertion of a gt was considered evidence of an occluded esophageal entrance ( effective cp ) . after the attempts to insert the gts were completed , tracheal intubation was performed while cp was applied . the position of the esophageal entrance in relation to the glottis ( midline versus lateral ) was assessed from the video recordings , with and without cp . we stopped the study when @ patients ( @ men and @ women ) qualified for and completed the study ( @-sided clopper-pearson confidence interval ( ci ) @ % to @ % , n = @ ) . advancement of either size gt into the esophagus could not be accomplished during cp in any patient but was easily done in all subjects when cp was not applied . this occurred whether the esophageal entrance was in a midline position or in a left or right lateral position relative to the glottis . esophageal patency was visually observed in the absence of cp , whereas occlusion of the esophageal entrance was observed during cp in all patients . without cp , the esophageal entrance was in a left lateral position in relation to the glottis in @ % ( -lsb- @ % ci , @ % -@ % ) -rsb- of patients , at midline in @ % ( ci , @ % -@ % ) , and in a right lateral position in @ % ( ci , @ % -@ % ) . the position did not change with cp . the current study provides additional visual and mechanical evidence supporting a success rate of at least @ % by using a cricoid force of @ n to occlude the esophageal entrance in anesthetized and paralyzed normal adult patients . the efficacy of the maneuver was independent of the position of the esophageal entrance relative to the glottis , whether midline or lateral .
24,557,105
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the polymorphic angiotensinogen ( agt ) gene is one of the most promising candidates for essential hypertension .", "the aim of this study was to examine the association between the a-@g variant of the agt gene and the blood pressure response to angiotensin-converting enzyme ( ace ) inhibitors in hypertensive subjects .", "five hundred and nine mildly to moderately hypertensive subjects received ace inhibitors for six weeks after a two-week run-in period .", "agt genotyping was performed by direct polymerase chain reaction amplification and deoxyribonucleic acid ( dna ) nucleotide sequencing from peripheral blood .", "the aa genotype , ag genotype , and gg genotype were present in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) of patients , respectively .", "as compared with patients carrying the aa or ag genotype , those carrying the gg genotype had significantly greater reductions in systolic blood pressure , diastolic blood pressure , pulse pressure and mean arterial pressure ( p = @ , @ , @ and @ , respectively ) .", "moreover , stepwise multiple linear regression analysis showed that the a-@g genotype was a significant predictor of systolic blood pressure and pulse pressure reductions ( p = @ and @ , respectively ) .", "our study indicates that the a-@g variant of the agt gene may be an important determinant of interindividual variation in the response to ace inhibitors ." ]
the polymorphic angiotensinogen ( agt ) gene is one of the most promising candidates for essential hypertension . the aim of this study was to examine the association between the a-@g variant of the agt gene and the blood pressure response to angiotensin-converting enzyme ( ace ) inhibitors in hypertensive subjects . five hundred and nine mildly to moderately hypertensive subjects received ace inhibitors for six weeks after a two-week run-in period . agt genotyping was performed by direct polymerase chain reaction amplification and deoxyribonucleic acid ( dna ) nucleotide sequencing from peripheral blood . the aa genotype , ag genotype , and gg genotype were present in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) of patients , respectively . as compared with patients carrying the aa or ag genotype , those carrying the gg genotype had significantly greater reductions in systolic blood pressure , diastolic blood pressure , pulse pressure and mean arterial pressure ( p = @ , @ , @ and @ , respectively ) . moreover , stepwise multiple linear regression analysis showed that the a-@g genotype was a significant predictor of systolic blood pressure and pulse pressure reductions ( p = @ and @ , respectively ) . our study indicates that the a-@g variant of the agt gene may be an important determinant of interindividual variation in the response to ace inhibitors .
25,143,324
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "contradictory results have been reported on the effects of nesiritide on renal function in patients with acute decompensated heart failure .", "we studied the effects of nesiritide on renal function during hospitalization for acute decompensated heart failure and associated outcomes .", "a total of @ patients were randomized to receive either nesiritide or placebo and creatinine was recorded in @ patients at baseline , after infusion , discharge , peak/nadir levels until day @ .", "worsening renal function was defined as an increase of serum creatinine > @ mg/dl and a change of @ % .", "median ( @ ( th ) -@ ( th ) percentile ) baseline creatinine was @ ( @-@ @ ) mg/dl and median baseline blood urea nitrogen was @ ( @-@ ) mmol/l .", "changes in both serum creatinine and blood urea nitrogen were similar in nesiritide-treated and placebo-treated patients ( p = @ and p = @ ) from baseline to discharge .", "in a multivariable model , independent predictors of change from randomization to hospital discharge in serum creatinine were a lower baseline blood urea nitrogen , higher systolic blood pressure , lower diastolic blood pressure , previous weight gain , and lower baseline potassium ( all p < @ ) .", "the frequency of worsening renal function during hospitalization was similar in the nesiritide and placebo group ( @ % and @ % , respectively ; odds ratio with nesiritide @ ; confidence interval , @-@ @ ; p = @ ) and was not associated with death alone and death or rehospitalization at @ days .", "however , baseline , discharge , and change in creatinine were associated with death alone and death or rehospitalization for heart failure ( all tests , p < @ ) .", "nesiritide did not affect renal function in patients with acute decompensated heart failure .", "baseline , discharge , and change in renal function were associated with @-day mortality or rehospitalization for heart failure ." ]
contradictory results have been reported on the effects of nesiritide on renal function in patients with acute decompensated heart failure . we studied the effects of nesiritide on renal function during hospitalization for acute decompensated heart failure and associated outcomes . a total of @ patients were randomized to receive either nesiritide or placebo and creatinine was recorded in @ patients at baseline , after infusion , discharge , peak/nadir levels until day @ . worsening renal function was defined as an increase of serum creatinine > @ mg/dl and a change of @ % . median ( @ ( th ) -@ ( th ) percentile ) baseline creatinine was @ ( @-@ @ ) mg/dl and median baseline blood urea nitrogen was @ ( @-@ ) mmol/l . changes in both serum creatinine and blood urea nitrogen were similar in nesiritide-treated and placebo-treated patients ( p = @ and p = @ ) from baseline to discharge . in a multivariable model , independent predictors of change from randomization to hospital discharge in serum creatinine were a lower baseline blood urea nitrogen , higher systolic blood pressure , lower diastolic blood pressure , previous weight gain , and lower baseline potassium ( all p < @ ) . the frequency of worsening renal function during hospitalization was similar in the nesiritide and placebo group ( @ % and @ % , respectively ; odds ratio with nesiritide @ ; confidence interval , @-@ @ ; p = @ ) and was not associated with death alone and death or rehospitalization at @ days . however , baseline , discharge , and change in creatinine were associated with death alone and death or rehospitalization for heart failure ( all tests , p < @ ) . nesiritide did not affect renal function in patients with acute decompensated heart failure . baseline , discharge , and change in renal function were associated with @-day mortality or rehospitalization for heart failure .
25,074,507
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "activated charcoal is commonly used to manage overdose or accidental ingestion of medicines .", "this study evaluated the effect of activated charcoal on apixaban exposure in human subjects .", "this was an open-label , three-treatment , three-period , randomized , crossover study of single-dose apixaban ( @ mg ) administered alone and with activated charcoal given at @ or @ h post-dose to healthy subjects .", "blood samples for assay of plasma apixaban concentration were collected up to @ h post-dose .", "pharmacokinetic parameters , including peak plasma concentration ( cmax ) , time to cmax ( tmax ) , area under the concentration-time curve from time @ to infinity ( aucinf ) , and terminal half-life ( t ) , were derived from apixaban plasma concentration-time data .", "a general linear mixed-effect model analysis of cmax and aucinf was performed to estimate the effect of activated charcoal on apixaban exposure .", "a total of @ subjects were treated and completed the study .", "aucinf for apixaban without activated charcoal decreased by @ and @ % , respectively , when charcoal was administered at @ and @ h post-dose .", "apixaban cmax and tmax were similar across treatments .", "the mean t for apixaban alone ( @ h ) decreased to ~ @ h when activated charcoal was administered at @ or @ h post-dose .", "overall , apixaban was well tolerated in this healthy population , and most adverse events were consistent with the known profile of activated charcoal .", "administration of activated charcoal up to @ h after apixaban reduced apixaban exposure and facilitated the elimination of apixaban .", "these results suggest that activated charcoal may be useful in the management of apixaban overdose or accidental ingestion ." ]
activated charcoal is commonly used to manage overdose or accidental ingestion of medicines . this study evaluated the effect of activated charcoal on apixaban exposure in human subjects . this was an open-label , three-treatment , three-period , randomized , crossover study of single-dose apixaban ( @ mg ) administered alone and with activated charcoal given at @ or @ h post-dose to healthy subjects . blood samples for assay of plasma apixaban concentration were collected up to @ h post-dose . pharmacokinetic parameters , including peak plasma concentration ( cmax ) , time to cmax ( tmax ) , area under the concentration-time curve from time @ to infinity ( aucinf ) , and terminal half-life ( t ) , were derived from apixaban plasma concentration-time data . a general linear mixed-effect model analysis of cmax and aucinf was performed to estimate the effect of activated charcoal on apixaban exposure . a total of @ subjects were treated and completed the study . aucinf for apixaban without activated charcoal decreased by @ and @ % , respectively , when charcoal was administered at @ and @ h post-dose . apixaban cmax and tmax were similar across treatments . the mean t for apixaban alone ( @ h ) decreased to ~ @ h when activated charcoal was administered at @ or @ h post-dose . overall , apixaban was well tolerated in this healthy population , and most adverse events were consistent with the known profile of activated charcoal . administration of activated charcoal up to @ h after apixaban reduced apixaban exposure and facilitated the elimination of apixaban . these results suggest that activated charcoal may be useful in the management of apixaban overdose or accidental ingestion .
24,277,644
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the purpose of this study was to assess the efficacy and safety of folfox@ , comprising infusional @-fluorouracil ( @-fu ) / leucovorin ( lv ) and oxaliplatin , with cetuximab compared with ufox , comprising uft , an oral prodrug of @-fu , lv , and oxaliplatin , with cetuximab as first-line treatment for mcrc .", "patients , unselected by tumor kras status , were randomized @:@ to folfox@ with cetuximab or ufox with cetuximab .", "treatment was continued until disease progression or unacceptable toxicity .", "the primary end point , assessed in the intention-to-treat population , was progression-free survival ( pfs ) .", "secondary end points included tumor response , overall survival , and safety .", "outcome according to kras mutation status was investigated .", "recruitment was curtailed at @ patients after reporting of the importance of tumor kras mutation status for cetuximab activity .", "baseline characteristics were balanced between treatment groups .", "pfs was significantly longer in the folfox@ with cetuximab group compared with ufox with cetuximab group ( median @ vs. @ months ; hazard ratio , @ ; @ % confidence interval -lsb- ci -rsb- , @-@ @ ; p = @ ) .", "the response rate was also significantly greater in the folfox@ with cetuximab group ( @ % vs. @ % , respectively ; odds ratio , @ ; @ % ci , @-@ @ ; p = @ ) , although overall survival was comparable .", "in the kras wild type subgroup , efficacy outcomes were similar to those in the intention-to-treat population .", "side effect profiles were manageable and consistent with expectations .", "in the first-line treatment of mcrc , ufox with cetuximab had an acceptable safety profile but inferior activity compared with folfox@ with cetuximab in relation to pfs and response .", "the regimens were comparable with regard to overall survival ." ]
the purpose of this study was to assess the efficacy and safety of folfox@ , comprising infusional @-fluorouracil ( @-fu ) / leucovorin ( lv ) and oxaliplatin , with cetuximab compared with ufox , comprising uft , an oral prodrug of @-fu , lv , and oxaliplatin , with cetuximab as first-line treatment for mcrc . patients , unselected by tumor kras status , were randomized @:@ to folfox@ with cetuximab or ufox with cetuximab . treatment was continued until disease progression or unacceptable toxicity . the primary end point , assessed in the intention-to-treat population , was progression-free survival ( pfs ) . secondary end points included tumor response , overall survival , and safety . outcome according to kras mutation status was investigated . recruitment was curtailed at @ patients after reporting of the importance of tumor kras mutation status for cetuximab activity . baseline characteristics were balanced between treatment groups . pfs was significantly longer in the folfox@ with cetuximab group compared with ufox with cetuximab group ( median @ vs. @ months ; hazard ratio , @ ; @ % confidence interval -lsb- ci -rsb- , @-@ @ ; p = @ ) . the response rate was also significantly greater in the folfox@ with cetuximab group ( @ % vs. @ % , respectively ; odds ratio , @ ; @ % ci , @-@ @ ; p = @ ) , although overall survival was comparable . in the kras wild type subgroup , efficacy outcomes were similar to those in the intention-to-treat population . side effect profiles were manageable and consistent with expectations . in the first-line treatment of mcrc , ufox with cetuximab had an acceptable safety profile but inferior activity compared with folfox@ with cetuximab in relation to pfs and response . the regimens were comparable with regard to overall survival .
24,370,353
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to observe the effect of xingnaojing injection combined with minimally invasive percutaneous drainage on brain edema and content of serum aquaporin-@ ( aqp@ ) in patients with moderate hypertensive basal ganglia hemorrhage , and discuss the treatment mechanism of xingnaojing injection combined with minimally invasive percutaneous drainage for cerebral hemorrhage .", "forty-two patients with moderate ( @-@ ml ) hypertensive basal ganglia hemorrhage ( < @ h ) were selected and randomly divided into two groups : the observation group ( n = @ ) and the control group ( n = @ ) .", "the neurological severity score were evaluated by the nihss ( national institutes of health stroke scale ) , the volume of brain edemas were measured by head ct , the serum levels of aqp@ were determined by elisa method on admission and @ and @ weeks after treatment .", "on admission , there was no significant difference in the scores of nihss , the volume of brain edemas and the level of serum aqp@ between the observation group and the control group .", "at the end of the first week after the treatment , the score of nihss of the observation group were lower than that of the control group , with significant different ( p < @ ) ; the observation group showed reduced volume of brain edemas than that on admission ( p < @ ) , whereas the control group the control group showed increased volume of brain edemas than that on admission ; the control group displayed increased level of serum aqp@ than that on admission , but without significant difference ; the observation group displayed decreased level of serum aqp@ than that on admission ( p < @ ) .", "at the end of the second week after the treatment , the control group showed decreased score of nihss than that on admission and at the end of the first week after treatment ( p < @ ) .", "compared with the control group , the observation group showed a much lower score of nihss ( p < @ ) , the control group displayed reduced volume of brain edemas than that on admission and at the end of the first week after treatment , but the observation group was even lower than the control group .", "both of observation and control groups displayed significantly reduced level of aqp@ ( p < @ ) , but the observation group showed a lower aqp@ level than that of the control group ( p < @ ) .", "the therapy of xingnaojing injection combined with minimally invasive percutaneous drainage could remarkably reduce brain edema , and promote neural functional recovery , thus could be selected as a therapeutic regimen for patients with moderate hypertensive basal ganglia hemorrhage ." ]
to observe the effect of xingnaojing injection combined with minimally invasive percutaneous drainage on brain edema and content of serum aquaporin-@ ( aqp@ ) in patients with moderate hypertensive basal ganglia hemorrhage , and discuss the treatment mechanism of xingnaojing injection combined with minimally invasive percutaneous drainage for cerebral hemorrhage . forty-two patients with moderate ( @-@ ml ) hypertensive basal ganglia hemorrhage ( < @ h ) were selected and randomly divided into two groups : the observation group ( n = @ ) and the control group ( n = @ ) . the neurological severity score were evaluated by the nihss ( national institutes of health stroke scale ) , the volume of brain edemas were measured by head ct , the serum levels of aqp@ were determined by elisa method on admission and @ and @ weeks after treatment . on admission , there was no significant difference in the scores of nihss , the volume of brain edemas and the level of serum aqp@ between the observation group and the control group . at the end of the first week after the treatment , the score of nihss of the observation group were lower than that of the control group , with significant different ( p < @ ) ; the observation group showed reduced volume of brain edemas than that on admission ( p < @ ) , whereas the control group the control group showed increased volume of brain edemas than that on admission ; the control group displayed increased level of serum aqp@ than that on admission , but without significant difference ; the observation group displayed decreased level of serum aqp@ than that on admission ( p < @ ) . at the end of the second week after the treatment , the control group showed decreased score of nihss than that on admission and at the end of the first week after treatment ( p < @ ) . compared with the control group , the observation group showed a much lower score of nihss ( p < @ ) , the control group displayed reduced volume of brain edemas than that on admission and at the end of the first week after treatment , but the observation group was even lower than the control group . both of observation and control groups displayed significantly reduced level of aqp@ ( p < @ ) , but the observation group showed a lower aqp@ level than that of the control group ( p < @ ) . the therapy of xingnaojing injection combined with minimally invasive percutaneous drainage could remarkably reduce brain edema , and promote neural functional recovery , thus could be selected as a therapeutic regimen for patients with moderate hypertensive basal ganglia hemorrhage .
25,276,983
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the efficacy between acupuncture and ondansetron in the prevention of delayed chemotherapy induced nausea and vomiting ( cinv ) .", "@ patients were randomized to receive either @ ) acupuncture at p@ point before chemotherapy infusion or @ ) ondansetron @ mg intravenously @ min before chemotherapy infusion in their first cycle with cross-over of antiemetic regimen in the consecutive cycle .", "all patients received dexamethasone @mg orally twice a day for @ days .", "patients were given additional does of ondansetron @ mg orally every @h if they experienced emesis .", "emetic episode , severity of nausea score of @-@ and adverse events were recorded .", "complete response was defined as no nausea , no vomiting and no requirement of additional antiemetic drugs .", "fact-g scale was used to evaluate quality of life ( qol ) @ days after each cycle of chemotherapy .", "the acupuncture group had a significantly higher rate of complete response in the prevention of delayed cinv ( @ % and @ % , p = @ ) .", "compared to another group , the acupuncture group reported significantly lower delayed nausea ( @ % and @ % , p = @ ) , nausea score ( p < @ ) and fewer dosages of additional oral ondansetron ( p = @ ) .", "adverse effects were also significantly lower in the acupuncture group with less frequent constipation ( p = @ ) and insomnia ( p = @ ) .", "overall fact-g scores were significantly higher in the acupuncture group .", "acupuncture is effective in preventing delayed cinv and in promoting better qol .", "with fewer adverse effects , it may be used as an alternative treatment option for cinv ." ]
to compare the efficacy between acupuncture and ondansetron in the prevention of delayed chemotherapy induced nausea and vomiting ( cinv ) . @ patients were randomized to receive either @ ) acupuncture at p@ point before chemotherapy infusion or @ ) ondansetron @ mg intravenously @ min before chemotherapy infusion in their first cycle with cross-over of antiemetic regimen in the consecutive cycle . all patients received dexamethasone @mg orally twice a day for @ days . patients were given additional does of ondansetron @ mg orally every @h if they experienced emesis . emetic episode , severity of nausea score of @-@ and adverse events were recorded . complete response was defined as no nausea , no vomiting and no requirement of additional antiemetic drugs . fact-g scale was used to evaluate quality of life ( qol ) @ days after each cycle of chemotherapy . the acupuncture group had a significantly higher rate of complete response in the prevention of delayed cinv ( @ % and @ % , p = @ ) . compared to another group , the acupuncture group reported significantly lower delayed nausea ( @ % and @ % , p = @ ) , nausea score ( p < @ ) and fewer dosages of additional oral ondansetron ( p = @ ) . adverse effects were also significantly lower in the acupuncture group with less frequent constipation ( p = @ ) and insomnia ( p = @ ) . overall fact-g scores were significantly higher in the acupuncture group . acupuncture is effective in preventing delayed cinv and in promoting better qol . with fewer adverse effects , it may be used as an alternative treatment option for cinv .
25,449,310
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to assess associations between patient characteristics , intensification of blood glucose-lowering treatment through oral glucose-lowering therapy and/or insulin and effective glycaemic control in type @ diabetes .", "@ patients from the action in diabetes and vascular disease : preterax and diamicron-mr controlled evaluation ( advance ) trial who were randomized to intensive glucose control or standard glucose control and followed up for a median of @years were categorized into two groups : effective glycaemic control -lsb- haemoglobin a@c ( hba@c ) @ % or a proportionate reduction in hba@c over @ % -rsb- or ineffective glycaemic control ( hba@c > @ % and a proportionate reduction in hba@c less than or equal to @ % ) .", "therapeutic intensification was defined as addition of an oral glucose-lowering agent or commencement of insulin .", "pooled logistic regression models examined the associations between patient factors , intensification and effective glycaemic control .", "a total of @ patients ( @ % ) , including @ in the standard treatment group achieved effective glycaemic control .", "compared to patients with ineffective control , patients with effective glycaemic control had shorter duration of diabetes and lower hba@c at baseline and at the time of treatment intensification .", "treatment intensification with addition of an oral agent or commencement of insulin was associated with a @ % -lsb- odds ratio , or : @ ( @ % confidence interval , ci : @-@ @ ) -rsb- and @ % -lsb- or : @ ( @ % ci : @-@ @ ) -rsb- greater chance of achieving effective glycaemic control , respectively .", "these associations were robust after adjustment for several baseline characteristics and not modified by the number of oral medications taken at the time of treatment intensification .", "effective glycaemic control was associated with treatment intensification at lower hba@c levels at all stages of the disease course and in both arms of the advance trial ." ]
the aim of this study was to assess associations between patient characteristics , intensification of blood glucose-lowering treatment through oral glucose-lowering therapy and/or insulin and effective glycaemic control in type @ diabetes . @ patients from the action in diabetes and vascular disease : preterax and diamicron-mr controlled evaluation ( advance ) trial who were randomized to intensive glucose control or standard glucose control and followed up for a median of @years were categorized into two groups : effective glycaemic control -lsb- haemoglobin a@c ( hba@c ) @ % or a proportionate reduction in hba@c over @ % -rsb- or ineffective glycaemic control ( hba@c > @ % and a proportionate reduction in hba@c less than or equal to @ % ) . therapeutic intensification was defined as addition of an oral glucose-lowering agent or commencement of insulin . pooled logistic regression models examined the associations between patient factors , intensification and effective glycaemic control . a total of @ patients ( @ % ) , including @ in the standard treatment group achieved effective glycaemic control . compared to patients with ineffective control , patients with effective glycaemic control had shorter duration of diabetes and lower hba@c at baseline and at the time of treatment intensification . treatment intensification with addition of an oral agent or commencement of insulin was associated with a @ % -lsb- odds ratio , or : @ ( @ % confidence interval , ci : @-@ @ ) -rsb- and @ % -lsb- or : @ ( @ % ci : @-@ @ ) -rsb- greater chance of achieving effective glycaemic control , respectively . these associations were robust after adjustment for several baseline characteristics and not modified by the number of oral medications taken at the time of treatment intensification . effective glycaemic control was associated with treatment intensification at lower hba@c levels at all stages of the disease course and in both arms of the advance trial .
24,251,579
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "panitumumab , a fully human anti-epidermal growth factor receptor monoclonal antibody ( mab ) , has demonstrated efficacy in patients with wild-type kras metastatic colorectal cancer ( mcrc ) .", "rilotumumab and ganitumab are investigational , fully human mabs against hepatocyte growth factor ( hgf ) / scatter factor and igf@r , respectively .", "here we evaluate combining rilotumumab or ganitumab with panitumumab in previously treated patients with wild-type kras mcrc .", "part @ was a phase ib dose-finding study of panitumumab plus rilotumumab .", "the primary endpoint was the incidence of dose-limiting toxicities ( dlt ) .", "part @ was a randomized phase ii trial of panitumumab in combination with rilotumumab , ganitumab , or placebo .", "the primary endpoint was objective response rate ( orr ) ; safety , progression-free survival ( pfs ) , and overall survival ( os ) were secondary endpoints .", "archival tissue specimens were collected for exploratory correlative work .", "in part @ , no dlts were reported .", "a recommended phase ii dose of @ mg/kg rilotumumab was selected .", "in part @ , for the panitumumab plus rilotumumab ( n = @ ) , panitumumab plus ganitumab ( n = @ ) , and panitumumab plus placebo arms ( n = @ ) , the orrs were @ % , @ % , and @ % , respectively .", "the median pfs was @ , @ , and @ months and median os @ , @ , and @ months , respectively .", "adverse events were tolerable .", "exploratory biomarker analyses , including met and igf-related protein expression , failed to indicate conclusive predictive evidence on efficacy endpoints .", "panitumumab plus rilotumumab met the prespecified criterion for improvement in orr whereas ganitumab did not .", "this is the first study to suggest a benefit for combining an hgf inhibitor ( rilotumumab ) with panitumumab in previously treated patients with wild-type kras mcrc ." ]
panitumumab , a fully human anti-epidermal growth factor receptor monoclonal antibody ( mab ) , has demonstrated efficacy in patients with wild-type kras metastatic colorectal cancer ( mcrc ) . rilotumumab and ganitumab are investigational , fully human mabs against hepatocyte growth factor ( hgf ) / scatter factor and igf@r , respectively . here we evaluate combining rilotumumab or ganitumab with panitumumab in previously treated patients with wild-type kras mcrc . part @ was a phase ib dose-finding study of panitumumab plus rilotumumab . the primary endpoint was the incidence of dose-limiting toxicities ( dlt ) . part @ was a randomized phase ii trial of panitumumab in combination with rilotumumab , ganitumab , or placebo . the primary endpoint was objective response rate ( orr ) ; safety , progression-free survival ( pfs ) , and overall survival ( os ) were secondary endpoints . archival tissue specimens were collected for exploratory correlative work . in part @ , no dlts were reported . a recommended phase ii dose of @ mg/kg rilotumumab was selected . in part @ , for the panitumumab plus rilotumumab ( n = @ ) , panitumumab plus ganitumab ( n = @ ) , and panitumumab plus placebo arms ( n = @ ) , the orrs were @ % , @ % , and @ % , respectively . the median pfs was @ , @ , and @ months and median os @ , @ , and @ months , respectively . adverse events were tolerable . exploratory biomarker analyses , including met and igf-related protein expression , failed to indicate conclusive predictive evidence on efficacy endpoints . panitumumab plus rilotumumab met the prespecified criterion for improvement in orr whereas ganitumab did not . this is the first study to suggest a benefit for combining an hgf inhibitor ( rilotumumab ) with panitumumab in previously treated patients with wild-type kras mcrc .
24,919,569
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate femtosecond laser-assisted and manual clear corneal incisions and their effect on surgically induced astigmatism ( sia ) and corneal higher-order aberrations ( hoas ) .", "in a prospective randomized study , conventional phacoemulsification with a @-mm clear corneal incision using a disposable keratome was performed in @ eyes of @ patients ( manual group ) , and femtosecond laser-assisted cataract surgery with a @-mm biplanar clear corneal tunnel created by a femtosecond laser ( lensx ; alcon laboratories , inc. , aliso viejo , ca ) was performed in @ eyes of @ patients ( femtosecond laser group ) .", "corneal topography readings and corneal wavefront aberrations ( diameter : @ mm ) were obtained using a scheimpflug camera ( pentacam hr ; oculus optikgerate , wetzlar , germany ) preoperatively and @ months postoperatively .", "there was no significant difference in sia between the groups ( femtosecond laser group : @ @ vs manual group : @ @ ; p = @ ) , but the axis deviation of the sia axis from the previously planned axis was significantly smaller in the femtosecond laser group compared to the manual group ( @ @ vs @ @ , respectively ; p = @ ) .", "corneal hoas increased significantly in both groups ( femtosecond laser group : @ @ to @ @ , p = @ ; manual group : @ @ to @ @ , p = @ ) , but preoperative and postoperative values did not differ significantly between them ( p = @ and @ , respectively ) .", "lower-order and total corneal aberration values remained stable in both groups ( p > @ ) .", "there was no difference in sia and induced hoas between manual and femtosecond laser-created clear corneal incisions ." ]
to evaluate femtosecond laser-assisted and manual clear corneal incisions and their effect on surgically induced astigmatism ( sia ) and corneal higher-order aberrations ( hoas ) . in a prospective randomized study , conventional phacoemulsification with a @-mm clear corneal incision using a disposable keratome was performed in @ eyes of @ patients ( manual group ) , and femtosecond laser-assisted cataract surgery with a @-mm biplanar clear corneal tunnel created by a femtosecond laser ( lensx ; alcon laboratories , inc. , aliso viejo , ca ) was performed in @ eyes of @ patients ( femtosecond laser group ) . corneal topography readings and corneal wavefront aberrations ( diameter : @ mm ) were obtained using a scheimpflug camera ( pentacam hr ; oculus optikgerate , wetzlar , germany ) preoperatively and @ months postoperatively . there was no significant difference in sia between the groups ( femtosecond laser group : @ @ vs manual group : @ @ ; p = @ ) , but the axis deviation of the sia axis from the previously planned axis was significantly smaller in the femtosecond laser group compared to the manual group ( @ @ vs @ @ , respectively ; p = @ ) . corneal hoas increased significantly in both groups ( femtosecond laser group : @ @ to @ @ , p = @ ; manual group : @ @ to @ @ , p = @ ) , but preoperative and postoperative values did not differ significantly between them ( p = @ and @ , respectively ) . lower-order and total corneal aberration values remained stable in both groups ( p > @ ) . there was no difference in sia and induced hoas between manual and femtosecond laser-created clear corneal incisions .
25,325,892
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "opioid-induced hyperalgesia is well known complication of acute high dose and chronic opioid therapy .", "in this study , we evaluated development of opioid-induced hyperalgesia following intraoperative short-term use of - opioid agonist fentanyl after coronary artery bypass surgery .", "@ patients undergoing elective coronary artery bypass graft surgery is divided into two groups .", "in group i ( low dose ) , anesthesia was induced with propofol @-@ @ mg/kg and fentanyl @ mcg/kg , in group ii ( high dose ) fentanyl @-@ mcg/kg was used .", "in group i , propofol @-@ mg/kg/h , fentanyl @-@ mcg/kg/h , in group ii fentanyl @-@ mcg/kg/h was used for maintenance of anesthesia .", "the tactile and thermal thresholds were measured before surgery and in @st , @rd and @th postoperative days by using von frey filaments and a thermal source , respectively .", "tactile thresholds were significantly decreased at the first ( @,@ and @ g ; p < @ ) and third ( @ and @ g ; p < @ ) postoperative days compared to baseline preoperative values ( @ , and @ g ; p = @ ) in two groups .", "postoperative @st ( @ and @ sec ; p < @ ) and @rd day ( @ and @ sec ; p < @ ) assessments showed a statistically significant thermal hyperalgesia compared to the preoperative baseline values ( @ and @ sec ; p = @ ) in two groups .", "this decrease in both tactile and thermal thresholds returned to baseline control values at the @th day of measurement .", "our results showed that patients undergoing coronary artery bypass surgery receiving fentanyl anesthesia developed postoperative tactile allodynia and thermal hyperalgesia and this was more prominent in high dose group ." ]
opioid-induced hyperalgesia is well known complication of acute high dose and chronic opioid therapy . in this study , we evaluated development of opioid-induced hyperalgesia following intraoperative short-term use of - opioid agonist fentanyl after coronary artery bypass surgery . @ patients undergoing elective coronary artery bypass graft surgery is divided into two groups . in group i ( low dose ) , anesthesia was induced with propofol @-@ @ mg/kg and fentanyl @ mcg/kg , in group ii ( high dose ) fentanyl @-@ mcg/kg was used . in group i , propofol @-@ mg/kg/h , fentanyl @-@ mcg/kg/h , in group ii fentanyl @-@ mcg/kg/h was used for maintenance of anesthesia . the tactile and thermal thresholds were measured before surgery and in @st , @rd and @th postoperative days by using von frey filaments and a thermal source , respectively . tactile thresholds were significantly decreased at the first ( @,@ and @ g ; p < @ ) and third ( @ and @ g ; p < @ ) postoperative days compared to baseline preoperative values ( @ , and @ g ; p = @ ) in two groups . postoperative @st ( @ and @ sec ; p < @ ) and @rd day ( @ and @ sec ; p < @ ) assessments showed a statistically significant thermal hyperalgesia compared to the preoperative baseline values ( @ and @ sec ; p = @ ) in two groups . this decrease in both tactile and thermal thresholds returned to baseline control values at the @th day of measurement . our results showed that patients undergoing coronary artery bypass surgery receiving fentanyl anesthesia developed postoperative tactile allodynia and thermal hyperalgesia and this was more prominent in high dose group .
25,491,618
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "rates of preventive asthma care after an asthma emergency department ( ed ) visit are low among inner-city children .", "the objective of this study was to test the efficacy of a clinician and caregiver feedback intervention ( int ) on improving preventive asthma care following an asthma ed visit compared to an attention control group ( con ) .", "children with persistent asthma and recent asthma ed visits ( n = @ ) were enrolled and randomized into a feedback intervention or an attention control group and followed for @ months .", "all children received nurse visits .", "data were obtained from interviews , child salivary cotinine levels and pharmacy records .", "standard t-test , chi-square and multiple logistic regression tests were used to test for differences between the groups for reporting greater than or equal to two primary care provider ( pcp ) preventive care visits for asthma over @ months .", "children were primarily male , young ( @-@ years ) , african american and medicaid insured .", "mean ed visits over @ months was high ( @ visits ) .", "no difference by group was noted for attending two or more pcp visits/@ months or having an asthma action plan ( aap ) .", "children having an aap at baseline were almost twice as likely to attend two or more pcp visits over @ months while controlling for asthma control , group status , child age and number of asthma ed visits .", "a clinician and caregiver feedback intervention was unsuccessful in increasing asthma preventive care compared to an attention control group .", "further research is needed to develop interventions to effectively prevent morbidity in high risk inner-city children with frequent ed utilization ." ]
rates of preventive asthma care after an asthma emergency department ( ed ) visit are low among inner-city children . the objective of this study was to test the efficacy of a clinician and caregiver feedback intervention ( int ) on improving preventive asthma care following an asthma ed visit compared to an attention control group ( con ) . children with persistent asthma and recent asthma ed visits ( n = @ ) were enrolled and randomized into a feedback intervention or an attention control group and followed for @ months . all children received nurse visits . data were obtained from interviews , child salivary cotinine levels and pharmacy records . standard t-test , chi-square and multiple logistic regression tests were used to test for differences between the groups for reporting greater than or equal to two primary care provider ( pcp ) preventive care visits for asthma over @ months . children were primarily male , young ( @-@ years ) , african american and medicaid insured . mean ed visits over @ months was high ( @ visits ) . no difference by group was noted for attending two or more pcp visits/@ months or having an asthma action plan ( aap ) . children having an aap at baseline were almost twice as likely to attend two or more pcp visits over @ months while controlling for asthma control , group status , child age and number of asthma ed visits . a clinician and caregiver feedback intervention was unsuccessful in increasing asthma preventive care compared to an attention control group . further research is needed to develop interventions to effectively prevent morbidity in high risk inner-city children with frequent ed utilization .
24,517,110
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the new forest parenting programme ( nfpp ) is a home-delivered , evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder ( adhd ) in preschool children .", "it has been adapted for use with ` hard-to-reach ' or ` difficult-to-treat ' children .", "this trial will compare the adapted-nfpp with a generic parenting group-based programme , incredible years ( iy ) , which has been recommended for children with preschool-type adhd symptoms .", "this multicentre randomized controlled trial comprises three arms : adapted-nfpp , iy and treatment as usual ( tau ) .", "a sample of @ parents of preschool-aged children with a research diagnosis of adhd enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio @:@:@ .", "participants in the adapted-nfpp and iy arms receive an induction visit followed by @ weekly parenting sessions of @hours ( adapted-nfpp ) or @hours ( iy ) over @ years .", "adapted-nfpp will be delivered as a one-to-one home-based intervention ; iy , as a group-based intervention .", "tau participants are offered a parenting programme at the end of the study .", "the primary objective is to test whether the adapted-nfpp produces beneficial effects in terms of core adhd symptoms .", "secondary objectives include examination of the treatment impact on secondary outcomes , a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function .", "the primary outcome is change in adhd symptoms , as measured by the parent-completed version of the snap-iv questionnaire , adjusted for pretreatment snap-iv score .", "secondary outcome measures are : a validated index of behaviour during child 's solo play ; teacher-reported snap-iv ( adhd scale ) ; teacher and parent snap-iv ( odd ) scale ; eyberg child behaviour inventory - oppositional defiant disorder scale ; revised client service receipt inventory - health economics costs measure and euroqol ( eq@d ) health-related quality-of-life measure .", "follow-up measures will be collected @months after treatment for participants allocated to adapted-nfpp and iy .", "this trial will provide evidence as to whether the adapted-nfpp is more effective and cost-effective than the recommended treatment and tau .", "it will also provide information about mediating factors ( improved parenting and neuropsychological function ) and moderating factors ( parent and child genetic factors ) in any increased benefit .", "current controlled trials , isrctn@ ." ]
the new forest parenting programme ( nfpp ) is a home-delivered , evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder ( adhd ) in preschool children . it has been adapted for use with ` hard-to-reach ' or ` difficult-to-treat ' children . this trial will compare the adapted-nfpp with a generic parenting group-based programme , incredible years ( iy ) , which has been recommended for children with preschool-type adhd symptoms . this multicentre randomized controlled trial comprises three arms : adapted-nfpp , iy and treatment as usual ( tau ) . a sample of @ parents of preschool-aged children with a research diagnosis of adhd enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio @:@:@ . participants in the adapted-nfpp and iy arms receive an induction visit followed by @ weekly parenting sessions of @hours ( adapted-nfpp ) or @hours ( iy ) over @ years . adapted-nfpp will be delivered as a one-to-one home-based intervention ; iy , as a group-based intervention . tau participants are offered a parenting programme at the end of the study . the primary objective is to test whether the adapted-nfpp produces beneficial effects in terms of core adhd symptoms . secondary objectives include examination of the treatment impact on secondary outcomes , a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function . the primary outcome is change in adhd symptoms , as measured by the parent-completed version of the snap-iv questionnaire , adjusted for pretreatment snap-iv score . secondary outcome measures are : a validated index of behaviour during child 's solo play ; teacher-reported snap-iv ( adhd scale ) ; teacher and parent snap-iv ( odd ) scale ; eyberg child behaviour inventory - oppositional defiant disorder scale ; revised client service receipt inventory - health economics costs measure and euroqol ( eq@d ) health-related quality-of-life measure . follow-up measures will be collected @months after treatment for participants allocated to adapted-nfpp and iy . this trial will provide evidence as to whether the adapted-nfpp is more effective and cost-effective than the recommended treatment and tau . it will also provide information about mediating factors ( improved parenting and neuropsychological function ) and moderating factors ( parent and child genetic factors ) in any increased benefit . current controlled trials , isrctn@ .
24,767,423
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "approximately @ % of all bone injuries are foot metatarsal fractures .", "metatarsal v basis fractures occur most frequently .", "the classification is done into the tuberosity avulsion fractures , jones fractures and stress fractures of the proximal diaphysis .", "the treatments of non-displaced fractures are generally conservative .", "the indication for surgical treatment depends on the load and the associated refracture rate .", "there are different types of treatment of these fractures .", "we present a possible approach to conservative treatments and show how different therapies affect healing of metatarsal v basis fractures and social reintegration of patients .", "a retrospective study consisted of @ patients analysed during a @-year period , whereas for a prospective analysis @ patients were included for a period of @ years .", "the treatment was performed using either a splint , closed bandage of theankle or special gttinger anklesplint bandage , with immediate pain-oriented full load in all groups .", "the subjective and objective treatment results were analysed accoding the gttinger phillips score .", "in retrospect , the fracture consolidation was observed after @ weeks full load-bearing was achieved after @ weeks on average .", "in the prospective analysis , the osseous consolidation occurred after @ weeks , and the full load was applied after @ weeks .", "after @ weeks the treatment with the anklesplint bandage was assessed with @ points of a maximum @ points of the phillips score .", "the anklesplint bandage was also the cheapest option in the cost comparison .", "using the immobilisation of the metatarsal supination with the anklesplint bandage the metatarsal v basis fractures can heal in a regular way .", "the functional outcome is better in comparison to the that with other treatments and it is a cost-effective treatment ." ]
approximately @ % of all bone injuries are foot metatarsal fractures . metatarsal v basis fractures occur most frequently . the classification is done into the tuberosity avulsion fractures , jones fractures and stress fractures of the proximal diaphysis . the treatments of non-displaced fractures are generally conservative . the indication for surgical treatment depends on the load and the associated refracture rate . there are different types of treatment of these fractures . we present a possible approach to conservative treatments and show how different therapies affect healing of metatarsal v basis fractures and social reintegration of patients . a retrospective study consisted of @ patients analysed during a @-year period , whereas for a prospective analysis @ patients were included for a period of @ years . the treatment was performed using either a splint , closed bandage of theankle or special gttinger anklesplint bandage , with immediate pain-oriented full load in all groups . the subjective and objective treatment results were analysed accoding the gttinger phillips score . in retrospect , the fracture consolidation was observed after @ weeks full load-bearing was achieved after @ weeks on average . in the prospective analysis , the osseous consolidation occurred after @ weeks , and the full load was applied after @ weeks . after @ weeks the treatment with the anklesplint bandage was assessed with @ points of a maximum @ points of the phillips score . the anklesplint bandage was also the cheapest option in the cost comparison . using the immobilisation of the metatarsal supination with the anklesplint bandage the metatarsal v basis fractures can heal in a regular way . the functional outcome is better in comparison to the that with other treatments and it is a cost-effective treatment .
25,569,591
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "epidural administration of dexamethasone might reduce postoperative pain in adults .", "we evaluated whether a caudal block of @ mg kg ( -@ ) dexamethasone combined with ropivacaine improves analgesic efficacy in children undergoing day-case orchiopexy .", "this randomized , double-blind study included @ children aged @ months to @ yr who underwent day-case , unilateral orchiopexy .", "patients received either @ ml kg ( -@ ) of @ % ropivacaine ( group c ) or @ ml kg ( -@ ) of @ % ropivacaine in which dexamethasone of @ mg kg ( -@ ) was mixed ( group d ) for caudal analgesia .", "postoperative pain scores , rescue analgesic consumption , and side-effects were evaluated @ h after operation .", "postoperative pain scores at @ and @ h post-surgery were significantly lower in group d than in group c. furthermore , the number of subjects who remained pain free up to @ h after operation was significantly greater in group d -lsb- @ of @ ( @ % ) -rsb- than in group c -lsb- four of @ ( @ % ) ; p < @ -rsb- .", "the number of subjects who received oral analgesic was significantly lower in group d -lsb- @ of @ ( @ % ) -rsb- than in group c -lsb- @ of @ ( @ % ) ; p = @ -rsb- .", "time to first oral analgesic administration after surgery was also significantly longer in group d than in group c ( p = @ ) .", "adverse events after surgery including vomiting , fever , wound infection , and wound dehiscence were comparable between the two groups .", "the addition of dexamethasone @ mg kg ( -@ ) to ropivacaine for caudal block can significantly improve analgesic efficacy in children undergoing orchiopexy .", "clinical trial registration nct@ ." ]
epidural administration of dexamethasone might reduce postoperative pain in adults . we evaluated whether a caudal block of @ mg kg ( -@ ) dexamethasone combined with ropivacaine improves analgesic efficacy in children undergoing day-case orchiopexy . this randomized , double-blind study included @ children aged @ months to @ yr who underwent day-case , unilateral orchiopexy . patients received either @ ml kg ( -@ ) of @ % ropivacaine ( group c ) or @ ml kg ( -@ ) of @ % ropivacaine in which dexamethasone of @ mg kg ( -@ ) was mixed ( group d ) for caudal analgesia . postoperative pain scores , rescue analgesic consumption , and side-effects were evaluated @ h after operation . postoperative pain scores at @ and @ h post-surgery were significantly lower in group d than in group c. furthermore , the number of subjects who remained pain free up to @ h after operation was significantly greater in group d -lsb- @ of @ ( @ % ) -rsb- than in group c -lsb- four of @ ( @ % ) ; p < @ -rsb- . the number of subjects who received oral analgesic was significantly lower in group d -lsb- @ of @ ( @ % ) -rsb- than in group c -lsb- @ of @ ( @ % ) ; p = @ -rsb- . time to first oral analgesic administration after surgery was also significantly longer in group d than in group c ( p = @ ) . adverse events after surgery including vomiting , fever , wound infection , and wound dehiscence were comparable between the two groups . the addition of dexamethasone @ mg kg ( -@ ) to ropivacaine for caudal block can significantly improve analgesic efficacy in children undergoing orchiopexy . clinical trial registration nct@ .
24,491,414
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "gastrointestinal ( gi ) discomfort , e.g. bloating or rumbling , is a common symptom in otherwise healthy adults .", "approximately @ % of the population , particularly women suffer from gastrointestinal discomfort and this affects quality of life .", "recent studies discovered a link between the body and mind , called the gut-brain axis .", "psychosocial factors , such as e.g. daily stress may cause altered gut physiology leading to ileum contractions and consequently gastrointestinal symptoms .", "in vitro and ex vivo studies clearly showed that a perilla frutescens extract combines prokinetic , antispasmodic and anti-inflammatory effects .", "the aim of the intervention was to investigate the effects of the proprietary perilla extract on gi discomfort in healthy subjects with gastrointestinal discomfort and reduced bowel movements in comparison to a placebo product .", "the pilot study was performed according to a double-blind , randomized , placebo-controlled parallel design .", "fifty healthy subjects with gastrointestinal discomfort and reduced bowel movements , @-@ years , documented their gi symptoms , stool frequency and consistency daily during a @-week run-in phase and a @-week intervention phase with perilla frutescens extract or placebo .", "gi symptoms were assessed on a @-point scale daily and average scores over @ days intervals were calculated .", "all gi symptoms were significantly improved over time by perilla frutescens extract during the intervention phase ( bloating : -@ , p = @ ; passage of gas : -@ , p = @ ; gi rumbling : -@ , p = @ ; feeling of fullness : -@ , p = @ ; abdominal discomfort : -@ , p = @ ) , whereas in the placebo group only abdominal discomfort was significantly improved ( -@ , p = @ ) .", "in the subgroup of women results were strengthened and a subscore out of bloating and abdominal discomfort was significantly improved against placebo ( @ % ci @ to @ ; p = @ ) .", "the demonstrated effects of perilla frutescens extract to improve gi complaints offer very promising results , taking into consideration the challenging set up of a nutritional human study with healthy subjects and in the area of digestive health , which is known for high placebo effects .", "nct@ at clinicaltrials.gov , registration date @rd august @ ." ]
gastrointestinal ( gi ) discomfort , e.g. bloating or rumbling , is a common symptom in otherwise healthy adults . approximately @ % of the population , particularly women suffer from gastrointestinal discomfort and this affects quality of life . recent studies discovered a link between the body and mind , called the gut-brain axis . psychosocial factors , such as e.g. daily stress may cause altered gut physiology leading to ileum contractions and consequently gastrointestinal symptoms . in vitro and ex vivo studies clearly showed that a perilla frutescens extract combines prokinetic , antispasmodic and anti-inflammatory effects . the aim of the intervention was to investigate the effects of the proprietary perilla extract on gi discomfort in healthy subjects with gastrointestinal discomfort and reduced bowel movements in comparison to a placebo product . the pilot study was performed according to a double-blind , randomized , placebo-controlled parallel design . fifty healthy subjects with gastrointestinal discomfort and reduced bowel movements , @-@ years , documented their gi symptoms , stool frequency and consistency daily during a @-week run-in phase and a @-week intervention phase with perilla frutescens extract or placebo . gi symptoms were assessed on a @-point scale daily and average scores over @ days intervals were calculated . all gi symptoms were significantly improved over time by perilla frutescens extract during the intervention phase ( bloating : -@ , p = @ ; passage of gas : -@ , p = @ ; gi rumbling : -@ , p = @ ; feeling of fullness : -@ , p = @ ; abdominal discomfort : -@ , p = @ ) , whereas in the placebo group only abdominal discomfort was significantly improved ( -@ , p = @ ) . in the subgroup of women results were strengthened and a subscore out of bloating and abdominal discomfort was significantly improved against placebo ( @ % ci @ to @ ; p = @ ) . the demonstrated effects of perilla frutescens extract to improve gi complaints offer very promising results , taking into consideration the challenging set up of a nutritional human study with healthy subjects and in the area of digestive health , which is known for high placebo effects . nct@ at clinicaltrials.gov , registration date @rd august @ .
24,885,816
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "atherosclerosis is a postprandial phenomenon .", "the balanced n-@ / n-@ pufa ratio contributing to the prevention of atherosclerosis has been well shown , but the effect of the ratio on postprandial metabolism has not been fully investigated .", "the aim of this study was to investigate the effects of the n-@ / n-@ pufas ratio on postprandial metabolism in hypertriacylglycerolemia patients , comparing them to healthy controls .", "test meals with @ ( high n-@ ) and @ ( low n-@ ) n-@ / n-@ pufas ratio were administered in a randomized crossover design to @ healthy and @ hypertriacylglycerolemia subjects .", "blood samples were collected for @ hours after meals to measure triglyceride ( tg ) , total cholesterol ( tc ) , hdl , apoa , apob , glucose , insulin , inflammatory makers including tumor necrosis factor alpha ( tnf - ) and interleukin-@ ( il-@ ) , endothelial function including nitric oxide ( no ) and endothelin-@ ( et-@ ) .", "according to repeated-measures anova , the postprandial response of lipid , glucose , insulin , inflammation and endothelial function were not significantly different between meals .", "the postprandial tg and no response were significantly different between healthy control ( hc ) and hypertriglyceridemia group ( htg ) after both meals ( p < @ ) .", "after both meals maximal change and iauc for tg was all higher in htg group than hc group , the difference was significant after low n-@ meal but not after high n-@ meal .", "the concentration of glucose , insulin , il-@ , tnf and et-@ at each time point was higher and no was lower in htg group , but the maximal change and iauc had no significant difference except for iauc of insulin , il-@ and diauc of no after low n-@ meal .", "the ratio of n-@ and n-@ maybe do not acutely influence the postprandial metabolism , inflammatory response and endothelial function , but the low n-@ meal can strengthen the difference between htg and hc group ." ]
atherosclerosis is a postprandial phenomenon . the balanced n-@ / n-@ pufa ratio contributing to the prevention of atherosclerosis has been well shown , but the effect of the ratio on postprandial metabolism has not been fully investigated . the aim of this study was to investigate the effects of the n-@ / n-@ pufas ratio on postprandial metabolism in hypertriacylglycerolemia patients , comparing them to healthy controls . test meals with @ ( high n-@ ) and @ ( low n-@ ) n-@ / n-@ pufas ratio were administered in a randomized crossover design to @ healthy and @ hypertriacylglycerolemia subjects . blood samples were collected for @ hours after meals to measure triglyceride ( tg ) , total cholesterol ( tc ) , hdl , apoa , apob , glucose , insulin , inflammatory makers including tumor necrosis factor alpha ( tnf - ) and interleukin-@ ( il-@ ) , endothelial function including nitric oxide ( no ) and endothelin-@ ( et-@ ) . according to repeated-measures anova , the postprandial response of lipid , glucose , insulin , inflammation and endothelial function were not significantly different between meals . the postprandial tg and no response were significantly different between healthy control ( hc ) and hypertriglyceridemia group ( htg ) after both meals ( p < @ ) . after both meals maximal change and iauc for tg was all higher in htg group than hc group , the difference was significant after low n-@ meal but not after high n-@ meal . the concentration of glucose , insulin , il-@ , tnf and et-@ at each time point was higher and no was lower in htg group , but the maximal change and iauc had no significant difference except for iauc of insulin , il-@ and diauc of no after low n-@ meal . the ratio of n-@ and n-@ maybe do not acutely influence the postprandial metabolism , inflammatory response and endothelial function , but the low n-@ meal can strengthen the difference between htg and hc group .
24,325,472
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "severe asthma is a major public health issue throughout the world .", "increased bronchial smooth muscle ( bsm ) mass , a characteristic feature of airway remodeling in severe asthma , is associated with resistance to high-intensity treatment and poor prognosis .", "in vitro , the ca ( @ + ) - channel blocker gallopamil decreased the proliferation of bsm cells from patients with severe asthma .", "we conducted a double-blind , randomized , placebo-controlled study to evaluate the effect of gallopamil on airway remodeling in patients with severe asthma .", "subjects received either gallopamil ( n = @ ) or placebo ( n = @ ) for @ year and were monitored for an additional @-month period .", "airway remodeling was analyzed at baseline and after treatment phase using both fiberoptic bronchoscopy and computed tomography scan .", "the primary end point was the bsm area .", "secondary end points included normalized bsm thickness and frequency of asthma exacerbations .", "bsm area was reduced in the gallopamil group ( baseline vs. end of treatment ) but was unchanged in the placebo group .", "between-group differences in bsm area were not significantly different in gallopamil versus placebo groups .", "by contrast , between-group differences in normalized bsm thickness were significantly different between the two groups .", "the mean number of exacerbations per month was not different during the treatment phase in gallopamil versus placebo group but was significantly lower in patients previously treated with gallopamil during the follow-up period .", "there were no differences between the groups with respect to overall side effects .", "gallopamil treatment for @ months reduces bsm remodeling and prevents the occurrence of asthma exacerbations .", "clinical trial registered with www.clinicaltrials.gov ( nct @ ) ." ]
severe asthma is a major public health issue throughout the world . increased bronchial smooth muscle ( bsm ) mass , a characteristic feature of airway remodeling in severe asthma , is associated with resistance to high-intensity treatment and poor prognosis . in vitro , the ca ( @ + ) - channel blocker gallopamil decreased the proliferation of bsm cells from patients with severe asthma . we conducted a double-blind , randomized , placebo-controlled study to evaluate the effect of gallopamil on airway remodeling in patients with severe asthma . subjects received either gallopamil ( n = @ ) or placebo ( n = @ ) for @ year and were monitored for an additional @-month period . airway remodeling was analyzed at baseline and after treatment phase using both fiberoptic bronchoscopy and computed tomography scan . the primary end point was the bsm area . secondary end points included normalized bsm thickness and frequency of asthma exacerbations . bsm area was reduced in the gallopamil group ( baseline vs. end of treatment ) but was unchanged in the placebo group . between-group differences in bsm area were not significantly different in gallopamil versus placebo groups . by contrast , between-group differences in normalized bsm thickness were significantly different between the two groups . the mean number of exacerbations per month was not different during the treatment phase in gallopamil versus placebo group but was significantly lower in patients previously treated with gallopamil during the follow-up period . there were no differences between the groups with respect to overall side effects . gallopamil treatment for @ months reduces bsm remodeling and prevents the occurrence of asthma exacerbations . clinical trial registered with www.clinicaltrials.gov ( nct @ ) .
25,633,090
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "previous studies have demonstrated variable patterns of longitudinal septal deformation in patients with left ventricular ( lv ) dysfunction and left bundle branch block .", "this prospective single center study was designed to assess the relationship between septal deformation patterns obtained by two-dimensional speckle-tracking echocardiography and response to cardiac resynchronization therapy ( crt ) .", "one hundred one patients with new york heart association class ii to iv heart failure , lv ejection fractions @ % , and left bundle branch block underwent echocardiography before crt .", "longitudinal two-dimensional speckle-tracking strain analysis in the apical four-chamber view identified three patterns : double-peaked systolic shortening ( pattern @ ) , early pre-ejection shortening peak followed by prominent systolic stretch ( pattern @ ) , and pseudonormal shortening with a late systolic shortening peak and less pronounced end-systolic stretch ( pattern @ ) .", "crt response was defined as a relative reduction in lv end-systolic volume of @ % at @-month follow-up .", "crt super-response was defined as an absolute lv ejection fraction of @ % associated with a relative reduction in lv end-systolic volume of @ % and an improvement in new york heart association functional class .", "cardiac death or hospitalization for heart failure during follow-up was systematically investigated .", "ninety-two percent of patients with pattern @ or @ were responders to crt compared with @ % with pattern @ ( p < @ ) .", "thirty-six percent of patients with pattern @ were super-responders compared with @ % of those with pattern @ and @ % of those with pattern @ ( p = @ ) .", "the improvement in lv volumes , lv ejection fraction , and global longitudinal strain after crt was better in patients with pattern @ or @ compared with those with pattern @ ( p < @ for all ) .", "eighteen-month outcomes were excellent in patients with pattern @ or @ , with event-free survival of @ @ % compared with @ @ % in patients with pattern @ ( p = @ ) .", "septal deformation strain pattern @ or @ is highly predictive of crt response .", "further studies are needed to identify predictors of `` nonresponse '' in patients with a pattern @ ." ]
previous studies have demonstrated variable patterns of longitudinal septal deformation in patients with left ventricular ( lv ) dysfunction and left bundle branch block . this prospective single center study was designed to assess the relationship between septal deformation patterns obtained by two-dimensional speckle-tracking echocardiography and response to cardiac resynchronization therapy ( crt ) . one hundred one patients with new york heart association class ii to iv heart failure , lv ejection fractions @ % , and left bundle branch block underwent echocardiography before crt . longitudinal two-dimensional speckle-tracking strain analysis in the apical four-chamber view identified three patterns : double-peaked systolic shortening ( pattern @ ) , early pre-ejection shortening peak followed by prominent systolic stretch ( pattern @ ) , and pseudonormal shortening with a late systolic shortening peak and less pronounced end-systolic stretch ( pattern @ ) . crt response was defined as a relative reduction in lv end-systolic volume of @ % at @-month follow-up . crt super-response was defined as an absolute lv ejection fraction of @ % associated with a relative reduction in lv end-systolic volume of @ % and an improvement in new york heart association functional class . cardiac death or hospitalization for heart failure during follow-up was systematically investigated . ninety-two percent of patients with pattern @ or @ were responders to crt compared with @ % with pattern @ ( p < @ ) . thirty-six percent of patients with pattern @ were super-responders compared with @ % of those with pattern @ and @ % of those with pattern @ ( p = @ ) . the improvement in lv volumes , lv ejection fraction , and global longitudinal strain after crt was better in patients with pattern @ or @ compared with those with pattern @ ( p < @ for all ) . eighteen-month outcomes were excellent in patients with pattern @ or @ , with event-free survival of @ @ % compared with @ @ % in patients with pattern @ ( p = @ ) . septal deformation strain pattern @ or @ is highly predictive of crt response . further studies are needed to identify predictors of `` nonresponse '' in patients with a pattern @ .
24,513,239
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control .", "this examiner-blind , randomized study used a crossover design .", "sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes ( spinbrush truly radiant deep clean -lsb- trdc -rsb- or spinbrush truly radiant extra whitening -lsb- trew -rsb- , church & dwight co. , inc. , princeton , nj , usa ) or an ada standard manual toothbrush ( mt ; american dental association , chicago , il , usa ) according to one of three computer-generated sequences .", "following instruction in the use of their assigned toothbrush , subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period .", "at the end of this period , the subjects returned to the study site after refraining from oral hygiene for @-@ hours , and from eating , drinking , and smoking for four hours .", "plaque was scored using the rustogi modification of the navy plaque index .", "subjects brushed under supervision with their assigned toothbrush for two minutes , and plaque was rescored .", "they were then given one of the alternate toothbrushes according to their assigned sequence , and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes .", "within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores ( p < @ ) , with respective whole mouth reductions of @ % , @ % , and @ % for mt , trdc , and trew .", "between-group analyses showed that trdc and trew were each significantly more effective ( p < @ ) than mt , as each showed at least twice as much of a reduction in whole mouth scores .", "both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined , with the greatest differences at interpoximal sites and sites presenting access difficulty , such as those in the lingual posterior region .", "additionally , trdc produced a statistically significant @ % greater reduction than trew ( p = @ ) in whole mouth plaque scores , and statistically significantly greater reductions in two of the subsets evaluated .", "both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque .", "while the finding that the trdc was significantly more effective than the trew in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance , longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes ." ]
the purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control . this examiner-blind , randomized study used a crossover design . sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes ( spinbrush truly radiant deep clean -lsb- trdc -rsb- or spinbrush truly radiant extra whitening -lsb- trew -rsb- , church & dwight co. , inc. , princeton , nj , usa ) or an ada standard manual toothbrush ( mt ; american dental association , chicago , il , usa ) according to one of three computer-generated sequences . following instruction in the use of their assigned toothbrush , subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period . at the end of this period , the subjects returned to the study site after refraining from oral hygiene for @-@ hours , and from eating , drinking , and smoking for four hours . plaque was scored using the rustogi modification of the navy plaque index . subjects brushed under supervision with their assigned toothbrush for two minutes , and plaque was rescored . they were then given one of the alternate toothbrushes according to their assigned sequence , and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes . within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores ( p < @ ) , with respective whole mouth reductions of @ % , @ % , and @ % for mt , trdc , and trew . between-group analyses showed that trdc and trew were each significantly more effective ( p < @ ) than mt , as each showed at least twice as much of a reduction in whole mouth scores . both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined , with the greatest differences at interpoximal sites and sites presenting access difficulty , such as those in the lingual posterior region . additionally , trdc produced a statistically significant @ % greater reduction than trew ( p = @ ) in whole mouth plaque scores , and statistically significantly greater reductions in two of the subsets evaluated . both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque . while the finding that the trdc was significantly more effective than the trew in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance , longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes .
25,122,975
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study 's aims were to detect and quantify bacterial dna in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence ( uui ) without clinical evidence of urinary tract infection ( uti ) and to determine if the presence of bacterial dna in baseline urine relates to either baseline urinary symptoms or uti risk after urinary tract instrumentation .", "women without clinical evidence of baseline uti were randomized to cystoscopic onabotulinum toxin a injection and oral placebo medication versus cystoscopic placebo injection and active oral medication .", "bacterial dna in participants ' catheterized urine was measured by quantitative polymerase chain reaction ( qpcr ) .", "bacterial dna was detected in the urine of @ % of participants ( @ out of @ ) .", "in these @ qpcr-positive participants , baseline daily uui episodes were greater than in the @ qpcr-negative participants ( @ -lsb- @ -rsb- vs @ -lsb- @ -rsb- , p = @ ) .", "neither symptom severity by questionnaire nor treatment outcome was associated with qpcr status or with qpcr level in qpcr-positive subjects .", "in contrast , the presence of urinary bacterial dna was associated with uti risk : only @ % of the qpcr-positive women developed a uti post-treatment , while @ % of the qpcr-negative women did so .", "the median qpcr level for qpcr-positive samples did not differ significantly by uti status ( uti @ ( @ ) vs no uti @ ( @ ) copies/ml , p = @ ) .", "these results may indicate a urinary bacterial contribution to both baseline uui and the risk of post-treatment uti ." ]
this study 's aims were to detect and quantify bacterial dna in the urine of randomized trial participants about to undergo treatment for urinary urgency incontinence ( uui ) without clinical evidence of urinary tract infection ( uti ) and to determine if the presence of bacterial dna in baseline urine relates to either baseline urinary symptoms or uti risk after urinary tract instrumentation . women without clinical evidence of baseline uti were randomized to cystoscopic onabotulinum toxin a injection and oral placebo medication versus cystoscopic placebo injection and active oral medication . bacterial dna in participants ' catheterized urine was measured by quantitative polymerase chain reaction ( qpcr ) . bacterial dna was detected in the urine of @ % of participants ( @ out of @ ) . in these @ qpcr-positive participants , baseline daily uui episodes were greater than in the @ qpcr-negative participants ( @ -lsb- @ -rsb- vs @ -lsb- @ -rsb- , p = @ ) . neither symptom severity by questionnaire nor treatment outcome was associated with qpcr status or with qpcr level in qpcr-positive subjects . in contrast , the presence of urinary bacterial dna was associated with uti risk : only @ % of the qpcr-positive women developed a uti post-treatment , while @ % of the qpcr-negative women did so . the median qpcr level for qpcr-positive samples did not differ significantly by uti status ( uti @ ( @ ) vs no uti @ ( @ ) copies/ml , p = @ ) . these results may indicate a urinary bacterial contribution to both baseline uui and the risk of post-treatment uti .
24,515,544
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the increased intraocular pressure ( iop ) - which decreases perfusion pressure on the optic nerve - increases by prone positioning ( @ ) .", "the aim of our study was to compare the effect of head rotation @ laterally in prone position on the increase in iop of upper placed and lower placed eyes in patients undergoing percutaneous nephrolithotomy ( pcnl ) .", "forty-five patients were randomly divided into @ groups .", "iop of the patients were recorded bilaterally in supine position before the operation had started .", "patients were turned to prone position .", "the head was placed on a prone headrest without external direct compression to both eyes .", "patients in group i were kept in strictly neutral prone position where as patients in group ii were placed prone with their heads rotated @ laterally to the right side .", "at the end of the operation , patients were turned to supine position and their iop was measured immediately .", "there was no difference related to demographics , duration of surgery , blood loss and fluid input data .", "iop values after surgery in prone position increased significantly compared to preoperative values in both groups ( p < @ ) .", "after surgery in prone position iop values of the upper positioned eyes in group ii were significantly lower than group i and lower positioned eyes in group ii ( p < @ ) .", "prone positioning increases iop .", "in patients with prone position with a head rotation of @ laterally , iop in the upper positioned eye was significantly lower ." ]
the increased intraocular pressure ( iop ) - which decreases perfusion pressure on the optic nerve - increases by prone positioning ( @ ) . the aim of our study was to compare the effect of head rotation @ laterally in prone position on the increase in iop of upper placed and lower placed eyes in patients undergoing percutaneous nephrolithotomy ( pcnl ) . forty-five patients were randomly divided into @ groups . iop of the patients were recorded bilaterally in supine position before the operation had started . patients were turned to prone position . the head was placed on a prone headrest without external direct compression to both eyes . patients in group i were kept in strictly neutral prone position where as patients in group ii were placed prone with their heads rotated @ laterally to the right side . at the end of the operation , patients were turned to supine position and their iop was measured immediately . there was no difference related to demographics , duration of surgery , blood loss and fluid input data . iop values after surgery in prone position increased significantly compared to preoperative values in both groups ( p < @ ) . after surgery in prone position iop values of the upper positioned eyes in group ii were significantly lower than group i and lower positioned eyes in group ii ( p < @ ) . prone positioning increases iop . in patients with prone position with a head rotation of @ laterally , iop in the upper positioned eye was significantly lower .
24,565,128
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "it is estimated that about @,@ inhabitants experience an out-of-hospital cardiac arrest ( ohca ) every year in europe .", "survival in out-of-hospital cardiac arrest is relatively low , generally between five per cent and @ % .", "being able to explore new methods to improve the relatively low survival rate is vital for people with these conditions .", "passive leg raise ( plr ) during cardiopulmonary resuscitation ( cpr ) has been found to improve cardiac preload and blood flow during chest compressions .", "the aim of our study is to evaluate whether early plr during cpr also has an impact on one-month survival in sudden and unexpected out-of-hospital cardiac arrest ( ohca ) .", "a prospective , randomized , controlled trial in which all patients ( @years ) receiving out-of hospital cpr are randomized by envelope to be treated with either plr or in the flat position .", "the ambulance crew use a special folding stool which allows the legs to be elevated about @ degrees .", "primary end-point : survival to one month .", "secondary end-point : survival to hospital admission to one month and to one year with acceptable cerebral performance classification ( cpc ) @-@ .", "plr is a simple and fast maneuver .", "we believe that the greatest benefit with plr is when performed early in the process , during the first minutes of cpr and before the first defibrillation .", "to reach power this study need @ patients , we hope that this method article will encourage other sites to contact us and take part in our study .", "clinicaltrials.gov nct@ ." ]
it is estimated that about @,@ inhabitants experience an out-of-hospital cardiac arrest ( ohca ) every year in europe . survival in out-of-hospital cardiac arrest is relatively low , generally between five per cent and @ % . being able to explore new methods to improve the relatively low survival rate is vital for people with these conditions . passive leg raise ( plr ) during cardiopulmonary resuscitation ( cpr ) has been found to improve cardiac preload and blood flow during chest compressions . the aim of our study is to evaluate whether early plr during cpr also has an impact on one-month survival in sudden and unexpected out-of-hospital cardiac arrest ( ohca ) . a prospective , randomized , controlled trial in which all patients ( @years ) receiving out-of hospital cpr are randomized by envelope to be treated with either plr or in the flat position . the ambulance crew use a special folding stool which allows the legs to be elevated about @ degrees . primary end-point : survival to one month . secondary end-point : survival to hospital admission to one month and to one year with acceptable cerebral performance classification ( cpc ) @-@ . plr is a simple and fast maneuver . we believe that the greatest benefit with plr is when performed early in the process , during the first minutes of cpr and before the first defibrillation . to reach power this study need @ patients , we hope that this method article will encourage other sites to contact us and take part in our study . clinicaltrials.gov nct@ .
24,993,861
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to investigate the possibility of influencing adolescents ' caries incidence , knowledge and attitudes to oral health and tobacco through a school-based oral health intervention programme .", "four schools in a county in sweden were randomised to one intervention and one control group .", "at the intervention schools , two dental hygienists worked @ h every week for two years .", "health education and preventive measures , such as fluoride varnish treatments every @ months , were performed .", "the control group had no intervention .", "the study included a total of @ participants aged @-@ years .", "outcome variables of the study were @ ) caries incidence assessed on bite-wing radiographs and @ ) knowledge and attitudes measured through questionnaires .", "the intervention programme impacted on the incidence of enamel caries , while no effect on dentin caries could be seen .", "data from the questionnaires showed that the adolescents considered their teeth as important .", "adolescents in the intervention group had better knowledge about oral health and oral hygiene compared to the control group after the two years , but no impact on attitudes toward tobacco could be seen .", "a majority of the adolescents were positive to the education about oral health and tobacco and they believed that the dental hygienists would help them improve their oral health .", "although the effects of the intervention as regards to caries incidence , knowledge and attitudes were limited , the presence of dental hygienists in school was appreciated by the adolescents and seemed to increase their interest in their oral health ." ]
to investigate the possibility of influencing adolescents ' caries incidence , knowledge and attitudes to oral health and tobacco through a school-based oral health intervention programme . four schools in a county in sweden were randomised to one intervention and one control group . at the intervention schools , two dental hygienists worked @ h every week for two years . health education and preventive measures , such as fluoride varnish treatments every @ months , were performed . the control group had no intervention . the study included a total of @ participants aged @-@ years . outcome variables of the study were @ ) caries incidence assessed on bite-wing radiographs and @ ) knowledge and attitudes measured through questionnaires . the intervention programme impacted on the incidence of enamel caries , while no effect on dentin caries could be seen . data from the questionnaires showed that the adolescents considered their teeth as important . adolescents in the intervention group had better knowledge about oral health and oral hygiene compared to the control group after the two years , but no impact on attitudes toward tobacco could be seen . a majority of the adolescents were positive to the education about oral health and tobacco and they believed that the dental hygienists would help them improve their oral health . although the effects of the intervention as regards to caries incidence , knowledge and attitudes were limited , the presence of dental hygienists in school was appreciated by the adolescents and seemed to increase their interest in their oral health .
24,914,429
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "traumatic brain injury ( tbi ) is a major cause of death and disability worldwide .", "progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with tbi .", "we conducted a double-blind , multicenter clinical trial in which patients with severe , moderate-to-severe , or moderate acute tbi ( glasgow coma scale score of @ to @ , on a scale from @ to @ , with lower scores indicating a lower level of consciousness ) were randomly assigned to intravenous progesterone or placebo , with the study treatment initiated within @ hours after injury and administered for a total of @ hours .", "efficacy was defined as an increase of @ percentage points in the proportion of patients with a favorable outcome , as determined with the use of the stratified dichotomy of the extended glasgow outcome scale score at @ months after injury .", "secondary outcomes included mortality and the disability rating scale score .", "a total of @ of the planned sample of @ patients underwent randomization before the trial was stopped for futility with respect to the primary outcome .", "the study groups were similar with regard to baseline characteristics ; the median age of the patients was @ years , @ % were men , @ % were black , and the mean injury severity score was @ ( on a scale from @ to @ , with higher scores indicating greater severity ) .", "the most frequent mechanism of injury was a motor vehicle accident .", "there was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome ( relative benefit of progesterone , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) .", "phlebitis or thrombophlebitis was more frequent in the progesterone group than in the placebo group ( relative risk , @ ; ci , @ to @ ) .", "there were no significant differences in the other prespecified safety outcomes .", "this clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute tbi .", "( funded by the national institute of neurological disorders and stroke and others ; protect iii clinicaltrials.gov number , nct@ . )" ]
traumatic brain injury ( tbi ) is a major cause of death and disability worldwide . progesterone has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving patients with tbi . we conducted a double-blind , multicenter clinical trial in which patients with severe , moderate-to-severe , or moderate acute tbi ( glasgow coma scale score of @ to @ , on a scale from @ to @ , with lower scores indicating a lower level of consciousness ) were randomly assigned to intravenous progesterone or placebo , with the study treatment initiated within @ hours after injury and administered for a total of @ hours . efficacy was defined as an increase of @ percentage points in the proportion of patients with a favorable outcome , as determined with the use of the stratified dichotomy of the extended glasgow outcome scale score at @ months after injury . secondary outcomes included mortality and the disability rating scale score . a total of @ of the planned sample of @ patients underwent randomization before the trial was stopped for futility with respect to the primary outcome . the study groups were similar with regard to baseline characteristics ; the median age of the patients was @ years , @ % were men , @ % were black , and the mean injury severity score was @ ( on a scale from @ to @ , with higher scores indicating greater severity ) . the most frequent mechanism of injury was a motor vehicle accident . there was no significant difference between the progesterone group and the placebo group in the proportion of patients with a favorable outcome ( relative benefit of progesterone , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) . phlebitis or thrombophlebitis was more frequent in the progesterone group than in the placebo group ( relative risk , @ ; ci , @ to @ ) . there were no significant differences in the other prespecified safety outcomes . this clinical trial did not show a benefit of progesterone over placebo in the improvement of outcomes in patients with acute tbi . ( funded by the national institute of neurological disorders and stroke and others ; protect iii clinicaltrials.gov number , nct@ . )
25,493,974
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "family members and caregivers play a significant supporting role in the rehabilitation process after stroke , a role that may increase with the growing trend of providing stroke rehabilitation in the individual 's own home after discharge from the hospital .", "to explore the impact of family involvement in exercise delivery after stroke from the perspective of the individual with stroke and his or her family member .", "a qualitative research design was used in which in-depth semi-structured interviews were carried out with participants who had taken part in an @-week family-mediated exercise program ( fame ) .", "a phenomenological theoretical framework and a grounded theory methodology were used to inform the data analysis .", "fifteen individuals with acute stroke and @ designated `` family '' members participated in the study after completion of an @-week , individually tailored , family-mediated exercise intervention .", "an overarching concept of patient-centeredness emerged after data analysis , which detailed the extent to which individuals with stroke and their families felt that their rehabilitation was enhanced by the active role of their families .", "four key themes that expanded the concept of patient-centeredness were identified : personalized nature of the reported benefits , therapeutic value of the program , family involvement , and caregiver commitment to program .", "this research serves to increase our understanding of the role of family members in the rehabilitation process after stroke , particularly in relation to exercise delivery , from the perspective of the individuals with stroke and their family members ." ]
family members and caregivers play a significant supporting role in the rehabilitation process after stroke , a role that may increase with the growing trend of providing stroke rehabilitation in the individual 's own home after discharge from the hospital . to explore the impact of family involvement in exercise delivery after stroke from the perspective of the individual with stroke and his or her family member . a qualitative research design was used in which in-depth semi-structured interviews were carried out with participants who had taken part in an @-week family-mediated exercise program ( fame ) . a phenomenological theoretical framework and a grounded theory methodology were used to inform the data analysis . fifteen individuals with acute stroke and @ designated `` family '' members participated in the study after completion of an @-week , individually tailored , family-mediated exercise intervention . an overarching concept of patient-centeredness emerged after data analysis , which detailed the extent to which individuals with stroke and their families felt that their rehabilitation was enhanced by the active role of their families . four key themes that expanded the concept of patient-centeredness were identified : personalized nature of the reported benefits , therapeutic value of the program , family involvement , and caregiver commitment to program . this research serves to increase our understanding of the role of family members in the rehabilitation process after stroke , particularly in relation to exercise delivery , from the perspective of the individuals with stroke and their family members .
24,521,841
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "scaling and root planing ( srp ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited .", "consequently , various adjunctive therapies have been investigated to improve clinical outcome .", "this study evaluated the clinical effects of one srp procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months .", "an examiner-blind clinical trial was conducted among @ subjects with moderate to advanced periodontitis who were randomized to srp alone or srp combined with prescription custom-tray application ( perio tray ) of @ % hydrogen peroxide gel ( perio gel ) for a period of three months , then extended to six months .", "following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase .", "srp was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( ppd ) and bleeding index ( bi ) , were conducted at baseline and after two , five , @ , and @ weeks of peroxide gel applications .", "clinical variables were compared by ancova and paired t-tests after each treatment interval .", "a total of @ test and @ control subjects completed the original three-month trial , of whom @ test and @ control subjects finished the three-month extension .", "after two weeks of peroxide gel use prior to srp , mean ppd for the test group significantly decreased from baseline by @ mm and mean bi significantly dropped by @ ; clinical parameters for the control group were unchanged .", "two weeks following srp , mean ppd significantly decreased from baseline by @ mm for the test group and @ mm for the control ; mean bi significantly dropped by @ for the test group and @ for the control .", "ten weeks following srp , mean ppd decreases were @ mm for the test group and @ mm for the control , and mean bi reductions were @ for the test group and @ for the control .", "for subjects who completed the three-month extension ( i.e. , @ weeks post-srp ) , mean ppd decreases were @ mm for the test group and @ mm for the control , and mean bi reductions were @ for the test group and @ for the control .", "analysis of deeper pockets ( i.e. , > @ mm at baseline ) showed the same relationship for ppd , but with larger differences between groups .", "for example , after two weeks of peroxide gel use prior to srp , mean ppd decreased by @ mm for the test group compared to @ mm for the control .", "two weeks after srp , mean ppd decreased from baseline by @ mm for the test group and @ mm for the control , and @ weeks after srp by @ mm for the test group and @ mm for the control .", "after the extension ( i.e. , @ weeks post-srp ) , mean ppd changed from baseline by @ mm for the test group and @ mm for the control .", "with the exception of bi at @ weeks post-srp , all reductions cited above for the test group were statistically significantly different from the control group for both ppd and bi for all comparisons .", "when compared with srp alone , clinical improvements in ppd ( e.g. , -@ mm for pockets > @ mm at baseline ) were maintained for up to six months after srp with adjunctive use of @ % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis ." ]
scaling and root planing ( srp ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited . consequently , various adjunctive therapies have been investigated to improve clinical outcome . this study evaluated the clinical effects of one srp procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months . an examiner-blind clinical trial was conducted among @ subjects with moderate to advanced periodontitis who were randomized to srp alone or srp combined with prescription custom-tray application ( perio tray ) of @ % hydrogen peroxide gel ( perio gel ) for a period of three months , then extended to six months . following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase . srp was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( ppd ) and bleeding index ( bi ) , were conducted at baseline and after two , five , @ , and @ weeks of peroxide gel applications . clinical variables were compared by ancova and paired t-tests after each treatment interval . a total of @ test and @ control subjects completed the original three-month trial , of whom @ test and @ control subjects finished the three-month extension . after two weeks of peroxide gel use prior to srp , mean ppd for the test group significantly decreased from baseline by @ mm and mean bi significantly dropped by @ ; clinical parameters for the control group were unchanged . two weeks following srp , mean ppd significantly decreased from baseline by @ mm for the test group and @ mm for the control ; mean bi significantly dropped by @ for the test group and @ for the control . ten weeks following srp , mean ppd decreases were @ mm for the test group and @ mm for the control , and mean bi reductions were @ for the test group and @ for the control . for subjects who completed the three-month extension ( i.e. , @ weeks post-srp ) , mean ppd decreases were @ mm for the test group and @ mm for the control , and mean bi reductions were @ for the test group and @ for the control . analysis of deeper pockets ( i.e. , > @ mm at baseline ) showed the same relationship for ppd , but with larger differences between groups . for example , after two weeks of peroxide gel use prior to srp , mean ppd decreased by @ mm for the test group compared to @ mm for the control . two weeks after srp , mean ppd decreased from baseline by @ mm for the test group and @ mm for the control , and @ weeks after srp by @ mm for the test group and @ mm for the control . after the extension ( i.e. , @ weeks post-srp ) , mean ppd changed from baseline by @ mm for the test group and @ mm for the control . with the exception of bi at @ weeks post-srp , all reductions cited above for the test group were statistically significantly different from the control group for both ppd and bi for all comparisons . when compared with srp alone , clinical improvements in ppd ( e.g. , -@ mm for pockets > @ mm at baseline ) were maintained for up to six months after srp with adjunctive use of @ % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis .
24,660,272
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the association between low-dose aspirin initiated before conception and the risk of preterm birth .", "this was a secondary analysis of the effects of aspirin in gestation and reproduction trial .", "women with a history of pregnancy loss ( original stratum : one loss less than @ weeks of gestation during the previous year ; expanded stratum : one or two losses with no restrictions on timing or gestational age of the losses ) were randomized to either daily low-dose aspirin ( @ mg , n = @ ) and folic acid or folic acid alone ( placebo ; n = @ ) .", "preterm birth was compared between groups using intent-to-treat analysis .", "preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( relative risk -lsb- rr -rsb- @ , @ % confidence interval -lsb- ci -rsb- @-@ @ ) ; spontaneous preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( rr @ , @ % ci @-@ @ ) ; medically indicated preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( rr @ , @ % ci @-@ @ ) .", "after restriction to confirmed pregnancies using inverse probability weighting , preterm birth rates were @ % and @ % ( rr @ , @ % ci @-@ @ ) and spontaneous preterm birth rates were @ % and @ % ( rr @ , @ % ci @-@ @ ) .", "in confirmed pregnancies in the original stratum , preterm birth occurred in @ % and @ % of the low-dose aspirin and placebo groups , respectively ( rr @ , @ % ci @-@ @ ) .", "preconception low-dose aspirin was not significantly associated with the overall rate of preterm birth .", "although the study was underpowered for this secondary analysis , numeric trends in favor of benefit , particularly in the women with a recent , single early pregnancy loss , warrant further investigation .", "clinicaltrials.gov , www.clinicaltrials.gov , nct@ ." ]
to evaluate the association between low-dose aspirin initiated before conception and the risk of preterm birth . this was a secondary analysis of the effects of aspirin in gestation and reproduction trial . women with a history of pregnancy loss ( original stratum : one loss less than @ weeks of gestation during the previous year ; expanded stratum : one or two losses with no restrictions on timing or gestational age of the losses ) were randomized to either daily low-dose aspirin ( @ mg , n = @ ) and folic acid or folic acid alone ( placebo ; n = @ ) . preterm birth was compared between groups using intent-to-treat analysis . preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( relative risk -lsb- rr -rsb- @ , @ % confidence interval -lsb- ci -rsb- @-@ @ ) ; spontaneous preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( rr @ , @ % ci @-@ @ ) ; medically indicated preterm birth rates were @ % ( @/@ low-dose aspirin ) and @ % ( @/@ placebo ) ( rr @ , @ % ci @-@ @ ) . after restriction to confirmed pregnancies using inverse probability weighting , preterm birth rates were @ % and @ % ( rr @ , @ % ci @-@ @ ) and spontaneous preterm birth rates were @ % and @ % ( rr @ , @ % ci @-@ @ ) . in confirmed pregnancies in the original stratum , preterm birth occurred in @ % and @ % of the low-dose aspirin and placebo groups , respectively ( rr @ , @ % ci @-@ @ ) . preconception low-dose aspirin was not significantly associated with the overall rate of preterm birth . although the study was underpowered for this secondary analysis , numeric trends in favor of benefit , particularly in the women with a recent , single early pregnancy loss , warrant further investigation . clinicaltrials.gov , www.clinicaltrials.gov , nct@ .
25,751,215
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "cardiovascular disease is the leading cause of death worldwide .", "higher oxidative stress may contribute to the pathogenesis of coronary artery disease ( cad ) .", "the purpose of this study was to investigate the effect of l-carnitine ( lc , @mg/d ) on the markers of oxidative stress and antioxidant enzymes activities in cad patients .", "we enrolled @ cad patients in the study .", "the cad patients were identified by cardiac catheterization as having at least @ % stenosis of one major coronary artery .", "the subjects were randomly assigned to the placebo ( n = @ ) and lc ( n = @ ) groups .", "the intervention was administered for @weeks .", "the levels of serum lc , plasma malondialdehyde ( mda ) , and erythrocyte antioxidant enzymes activities -lsb- catalase ( cat ) , superoxide dismutase ( sod ) , glutathione peroxidase ( gpx ) -rsb- were measured before and after intervention .", "thirty-nine subjects completed the study ( placebo , n = @ ; lc , n = @ ) .", "after @weeks of lc supplementation , the level of mda was significantly reduced ( @ to @ mol/l , p = @ ) and the level of lc ( @ to @ mol/l , p = @ ) and antioxidant enzymes activities -lsb- cat ( @ to @ u/mg of protein , p = @ ) , sod ( @ to @ u/mg of protein , p < @ ) , and gpx ( @ to @ u/mg of protein , p = @ ) -rsb- were significantly increased .", "the level of lc was significantly positively correlated with the antioxidant enzymes activities ( cat , = @ , p = @ ; sod , = @ , p < @ ) .", "lc supplementation at a dose of @mg/d was associated with a significant reduction in oxidative stress and an increase in antioxidant enzymes activities in cad patients .", "cad patients might benefit from using lc supplements to increase their anti-oxidation capacity .", "clinical trials.gov identifier : nct@ ." ]
cardiovascular disease is the leading cause of death worldwide . higher oxidative stress may contribute to the pathogenesis of coronary artery disease ( cad ) . the purpose of this study was to investigate the effect of l-carnitine ( lc , @mg/d ) on the markers of oxidative stress and antioxidant enzymes activities in cad patients . we enrolled @ cad patients in the study . the cad patients were identified by cardiac catheterization as having at least @ % stenosis of one major coronary artery . the subjects were randomly assigned to the placebo ( n = @ ) and lc ( n = @ ) groups . the intervention was administered for @weeks . the levels of serum lc , plasma malondialdehyde ( mda ) , and erythrocyte antioxidant enzymes activities -lsb- catalase ( cat ) , superoxide dismutase ( sod ) , glutathione peroxidase ( gpx ) -rsb- were measured before and after intervention . thirty-nine subjects completed the study ( placebo , n = @ ; lc , n = @ ) . after @weeks of lc supplementation , the level of mda was significantly reduced ( @ to @ mol/l , p = @ ) and the level of lc ( @ to @ mol/l , p = @ ) and antioxidant enzymes activities -lsb- cat ( @ to @ u/mg of protein , p = @ ) , sod ( @ to @ u/mg of protein , p < @ ) , and gpx ( @ to @ u/mg of protein , p = @ ) -rsb- were significantly increased . the level of lc was significantly positively correlated with the antioxidant enzymes activities ( cat , = @ , p = @ ; sod , = @ , p < @ ) . lc supplementation at a dose of @mg/d was associated with a significant reduction in oxidative stress and an increase in antioxidant enzymes activities in cad patients . cad patients might benefit from using lc supplements to increase their anti-oxidation capacity . clinical trials.gov identifier : nct@ .
25,092,108
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "patients with recurrent or metastatic squamous-cell carcinoma of the head and neck ( hnscc ) progressing after first-line platinum regimens have a poor prognosis and few treatment options .", "afatinib , an irreversible erbb family blocker , has shown efficacy in a phase @ study in this setting .", "we aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic hnscc progressing on or after platinum-based therapy .", "in this open-label , phase @ , randomised controlled trial conducted in @ centres in @ countries , we enrolled patients aged @ years or older with histologically or cytologically confirmed hnscc that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an eastern cooperative oncology group ( ecog ) performance status of @ or @ .", "previous treatment with more than one systemic regimen in this setting was not allowed ; previous treatment with egfr-targeted antibody therapy ( but not egfr-targeted tyrosine-kinase inhibitors ) was allowed .", "we randomly assigned eligible patients in a @:@ ratio to receive oral afatinib ( @ mg/day ) or intravenous methotrexate ( @ mg/m ( @ ) per week ) , stratified by ecog performance status and previous egfr-targeted antibody therapy for recurrent or metastatic disease .", "randomisation was done centrally with an interactive voice or web-based response system .", "clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner .", "the primary endpoint was progression-free survival as assessed by an independent , central imaging review committee .", "efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug .", "this ongoing study is registered with clinicaltrials.gov , number nct@ .", "between jan @ , @ , and dec @ , @ , we enrolled @ patients and randomly assigned @ to afatinib and @ to methotrexate .", "after a median follow-up of @ months ( iqr @-@ ) , progression-free survival was longer in the afatinib group than in the methotrexate group ( median @ months -lsb- @ % ci @-@ -rsb- for the afatinib group vs @ months -lsb- @-@ -rsb- for the methotrexate group ; hazard ratio -lsb- hr -rsb- @ -lsb- @ % ci @-@ -rsb- , p = @ ) .", "the most frequent grade @ or @ drug-related adverse events were rash or acne ( @ -lsb- @ % -rsb- of @ patients in the afatinib group vs none of @ patients in the methotrexate group ) , diarrhoea ( @ -lsb- @ % -rsb- vs three -lsb- @ % -rsb- ) , stomatitis ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) , fatigue ( @ -lsb- @ % -rsb- vs five -lsb- @ % -rsb- ) , and neutropenia ( @ -lsb- < @ % -rsb- vs @ -lsb- @ % -rsb- ) ; serious adverse events occurred in @ ( @ % ) of afatinib-treated patients and @ ( @ % ) of methotrexate-treated patients .", "afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile .", "these findings provide important new insights into the treatment of this patient population and support further investigations with irreversible erbb family blockers in hnscc .", "boehringer ingelheim ." ]
patients with recurrent or metastatic squamous-cell carcinoma of the head and neck ( hnscc ) progressing after first-line platinum regimens have a poor prognosis and few treatment options . afatinib , an irreversible erbb family blocker , has shown efficacy in a phase @ study in this setting . we aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic hnscc progressing on or after platinum-based therapy . in this open-label , phase @ , randomised controlled trial conducted in @ centres in @ countries , we enrolled patients aged @ years or older with histologically or cytologically confirmed hnscc that was recurrent , metastatic , or both who had progressed on or after first-line platinum-based therapy , were not amenable for salvage surgery or radiotherapy , and who had an eastern cooperative oncology group ( ecog ) performance status of @ or @ . previous treatment with more than one systemic regimen in this setting was not allowed ; previous treatment with egfr-targeted antibody therapy ( but not egfr-targeted tyrosine-kinase inhibitors ) was allowed . we randomly assigned eligible patients in a @:@ ratio to receive oral afatinib ( @ mg/day ) or intravenous methotrexate ( @ mg/m ( @ ) per week ) , stratified by ecog performance status and previous egfr-targeted antibody therapy for recurrent or metastatic disease . randomisation was done centrally with an interactive voice or web-based response system . clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner . the primary endpoint was progression-free survival as assessed by an independent , central imaging review committee . efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug . this ongoing study is registered with clinicaltrials.gov , number nct@ . between jan @ , @ , and dec @ , @ , we enrolled @ patients and randomly assigned @ to afatinib and @ to methotrexate . after a median follow-up of @ months ( iqr @-@ ) , progression-free survival was longer in the afatinib group than in the methotrexate group ( median @ months -lsb- @ % ci @-@ -rsb- for the afatinib group vs @ months -lsb- @-@ -rsb- for the methotrexate group ; hazard ratio -lsb- hr -rsb- @ -lsb- @ % ci @-@ -rsb- , p = @ ) . the most frequent grade @ or @ drug-related adverse events were rash or acne ( @ -lsb- @ % -rsb- of @ patients in the afatinib group vs none of @ patients in the methotrexate group ) , diarrhoea ( @ -lsb- @ % -rsb- vs three -lsb- @ % -rsb- ) , stomatitis ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) , fatigue ( @ -lsb- @ % -rsb- vs five -lsb- @ % -rsb- ) , and neutropenia ( @ -lsb- < @ % -rsb- vs @ -lsb- @ % -rsb- ) ; serious adverse events occurred in @ ( @ % ) of afatinib-treated patients and @ ( @ % ) of methotrexate-treated patients . afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile . these findings provide important new insights into the treatment of this patient population and support further investigations with irreversible erbb family blockers in hnscc . boehringer ingelheim .
25,892,145
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population .", "we evaluated the immunogenicity and safety of a @-dose infant/toddler regimen of menacwy-crm given at @ , @ , @ , and @ months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-hemophilus influenzae type b-inactivated poliovirus-combination vaccine ( dtap-ipv/hib ) , hepatitis b vaccine ( hbv ) , @ - or @-valent conjugate pneumococcal vaccine ( pcv ) , and measles , mumps , and rubella vaccine ( mmr ) .", "four doses of menacwy-crm induced hsba titers @ in @ % , @ % , @ % , and @ % of participants against serogroups a , c , w-@ , and y , respectively .", "hsba titers @ were present in @-@ % of participants after the first @ doses .", "a categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with menacwy-crm were non-inferior to routine vaccines alone , except for seroresponse to the pertussis antigen fimbriae .", "the reactogenicity profile was not affected when menacwy-crm was administered concomitantly with routine vaccines .", "menacwy-crm administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations .", "healthy @ month old infants were randomized to receive menacwy-crm with routine vaccines ( n = @ ) or routine vaccines alone ( n = @ ) .", "immunogenicity was assessed by serum bactericidal assay using human complement ( hsba ) .", "medically attended adverse events ( aes ) , serious aes ( saes ) and aes leading to study withdrawal were collected throughout the study period ." ]
infants are at the highest risk for meningococcal disease and a broadly protective and safe vaccine is an unmet need in this youngest population . we evaluated the immunogenicity and safety of a @-dose infant/toddler regimen of menacwy-crm given at @ , @ , @ , and @ months of age concomitantly with pentavalent diphtheria-tetanus-acellular pertussis-hemophilus influenzae type b-inactivated poliovirus-combination vaccine ( dtap-ipv/hib ) , hepatitis b vaccine ( hbv ) , @ - or @-valent conjugate pneumococcal vaccine ( pcv ) , and measles , mumps , and rubella vaccine ( mmr ) . four doses of menacwy-crm induced hsba titers @ in @ % , @ % , @ % , and @ % of participants against serogroups a , c , w-@ , and y , respectively . hsba titers @ were present in @-@ % of participants after the first @ doses . a categorical linear analysis incorporating vaccine group and study center showed responses to routine vaccines administered with menacwy-crm were non-inferior to routine vaccines alone , except for seroresponse to the pertussis antigen fimbriae . the reactogenicity profile was not affected when menacwy-crm was administered concomitantly with routine vaccines . menacwy-crm administered with routine concomitant vaccinations in young infants was well tolerated and induced highly immunogenic responses against each of the serogroups without significant interference with the immune responses to routine infant vaccinations . healthy @ month old infants were randomized to receive menacwy-crm with routine vaccines ( n = @ ) or routine vaccines alone ( n = @ ) . immunogenicity was assessed by serum bactericidal assay using human complement ( hsba ) . medically attended adverse events ( aes ) , serious aes ( saes ) and aes leading to study withdrawal were collected throughout the study period .
24,220,326
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS", "METHODS", "METHODS" ]
[ "to compare the efficacy on acute pain treated under the different time of needle retention so as to provide the scientific evidence for the optimization of needle retention time for acupuncture analgesia .", "eighty cases of acute pain ( acute lumbar sprain , stiffness of neck ) were randomized into @ groups .", "acupuncture was applied to all the patients .", "after the arrival of needling sensation , the needles were retained for @ min , @ min , @ min and @ min in different groups separately .", "for acute lumbar sprain , ashi ( extra ) , houxi ( si @ ) and weizhong ( bl @ ) were the main points .", "for stiffness of neck , ashi ( extra ) , fengchi ( gb @ ) and lieque ( lu @ ) were the main points .", "mcgill pain scale , the internationally recognized pain description and measurement was adopted to observe the indexes and record the score changes of each item of pain symptoms before and @ months after treatment .", "the immediate analgesic efficacy under different time of needle retention and the longterm efficacy in follow-up visit @ months after treatment were compared and assessed among the groups .", "the scores of visual analogue scale ( vas ) and present pain intensity ( ppi ) after treatment were all improved significantly as compared with those before treatment in the @ groups ( all p < @ ) , and the result in the @ min group was superior to the other @ groups ( vas : @ + / -@ vs @ + / -@ , @ + / -@ , @ + / -@ ; ppi : @ + / -@ vs @ + / -@ , @ + / -@ , @ + / -@ , all p < @ ) .", "the total effective rate of the immediate analgesia was @ % ( @/@ ) in the @ min group , which was better than that in each of the other @ groups .", "the @ min of needle retention achieves the best efficacy of acupuncture analgesia in treatment of acute pain ." ]
to compare the efficacy on acute pain treated under the different time of needle retention so as to provide the scientific evidence for the optimization of needle retention time for acupuncture analgesia . eighty cases of acute pain ( acute lumbar sprain , stiffness of neck ) were randomized into @ groups . acupuncture was applied to all the patients . after the arrival of needling sensation , the needles were retained for @ min , @ min , @ min and @ min in different groups separately . for acute lumbar sprain , ashi ( extra ) , houxi ( si @ ) and weizhong ( bl @ ) were the main points . for stiffness of neck , ashi ( extra ) , fengchi ( gb @ ) and lieque ( lu @ ) were the main points . mcgill pain scale , the internationally recognized pain description and measurement was adopted to observe the indexes and record the score changes of each item of pain symptoms before and @ months after treatment . the immediate analgesic efficacy under different time of needle retention and the longterm efficacy in follow-up visit @ months after treatment were compared and assessed among the groups . the scores of visual analogue scale ( vas ) and present pain intensity ( ppi ) after treatment were all improved significantly as compared with those before treatment in the @ groups ( all p < @ ) , and the result in the @ min group was superior to the other @ groups ( vas : @ + / -@ vs @ + / -@ , @ + / -@ , @ + / -@ ; ppi : @ + / -@ vs @ + / -@ , @ + / -@ , @ + / -@ , all p < @ ) . the total effective rate of the immediate analgesia was @ % ( @/@ ) in the @ min group , which was better than that in each of the other @ groups . the @ min of needle retention achieves the best efficacy of acupuncture analgesia in treatment of acute pain .
24,494,283
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of the study was to determine whether experimental manipulation of sense of control would change moderate drinkers ' ( n = @ ) task-specific motivational structure and explicit and implicit determinants of their urge to drink alcohol .", "the effects of various levels of information-enhancement and goal-setting on participants ' performance on experimental tasks were assessed .", "participants were randomly assigned to a high-sense-of-control , low-sense-of-control , or no-intervention group .", "dependent measures were indices derived from a task-specific version of the personal concerns inventory and the shapiro control inventory , alcohol urge questionnaire , and alcohol stroop test .", "at baseline , there were no differences among the groups on any of the measures ; however , post-experimentally , induced sense of control had led to increases in adaptive motivation and decreases in explicit and implicit measures of the urge to drink .", "the results show that sense of control can be experimentally induced .", "this finding has important clinical implications ." ]
the aim of the study was to determine whether experimental manipulation of sense of control would change moderate drinkers ' ( n = @ ) task-specific motivational structure and explicit and implicit determinants of their urge to drink alcohol . the effects of various levels of information-enhancement and goal-setting on participants ' performance on experimental tasks were assessed . participants were randomly assigned to a high-sense-of-control , low-sense-of-control , or no-intervention group . dependent measures were indices derived from a task-specific version of the personal concerns inventory and the shapiro control inventory , alcohol urge questionnaire , and alcohol stroop test . at baseline , there were no differences among the groups on any of the measures ; however , post-experimentally , induced sense of control had led to increases in adaptive motivation and decreases in explicit and implicit measures of the urge to drink . the results show that sense of control can be experimentally induced . this finding has important clinical implications .
24,751,369
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to estimate contraceptive efficacy , safety , acceptability , and fit of a single-size diaphragm used with contraceptive gel .", "we conducted a multicenter trial in which @ couples used the single-size diaphragm , @ randomized to acid-buffering gel and @ to nonoxynol-@ , for at least @ days and six menstrual cycles .", "visits were at enrollment and after menstrual cycles @ , @ , and @ .", "study outcomes included pregnancy probability , safety , acceptability , and fit .", "pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels .", "most ( @/@ -lsb- @ % -rsb- ) women could be fitted with the single-size diaphragm .", "a total of @ of @ ( @ % ) provided follow-up .", "the @ study pregnancies yielded @-month kaplan-meier cumulative typical use pregnancy probabilities per @ women with @ % confidence intervals ( cis ) of @ ( @-@ @ ) for all users and @ ( @-@ @ ) and @ ( @-@ @ ) with acid-buffering gel and nonoxynol-@ , respectively .", "historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of @ compared with @ per @ women for the standard diaphragm ( -lsb- rounded -rsb- difference @ , @ % ci -@ to @ ) .", "approximately half ( @ % ) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis .", "most ( @/@ -lsb- @ % -rsb- ) liked the diaphragm .", "results suggest that if provided by a clinician , @ % ( @ % ci @-@ % ) could insert , correctly position , and remove the diaphragm .", "the single-size diaphragm was safe , as effective as a standard diaphragm , and acceptable when used with contraceptive gel .", "clinicaltrials.gov , www.clinicaltrials.gov , nct@ ." ]
to estimate contraceptive efficacy , safety , acceptability , and fit of a single-size diaphragm used with contraceptive gel . we conducted a multicenter trial in which @ couples used the single-size diaphragm , @ randomized to acid-buffering gel and @ to nonoxynol-@ , for at least @ days and six menstrual cycles . visits were at enrollment and after menstrual cycles @ , @ , and @ . study outcomes included pregnancy probability , safety , acceptability , and fit . pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels . most ( @/@ -lsb- @ % -rsb- ) women could be fitted with the single-size diaphragm . a total of @ of @ ( @ % ) provided follow-up . the @ study pregnancies yielded @-month kaplan-meier cumulative typical use pregnancy probabilities per @ women with @ % confidence intervals ( cis ) of @ ( @-@ @ ) for all users and @ ( @-@ @ ) and @ ( @-@ @ ) with acid-buffering gel and nonoxynol-@ , respectively . historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of @ compared with @ per @ women for the standard diaphragm ( -lsb- rounded -rsb- difference @ , @ % ci -@ to @ ) . approximately half ( @ % ) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis . most ( @/@ -lsb- @ % -rsb- ) liked the diaphragm . results suggest that if provided by a clinician , @ % ( @ % ci @-@ % ) could insert , correctly position , and remove the diaphragm . the single-size diaphragm was safe , as effective as a standard diaphragm , and acceptable when used with contraceptive gel . clinicaltrials.gov , www.clinicaltrials.gov , nct@ .
25,751,199
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "the present study investigated the effectiveness of a newly developed @-week self-compassion group intervention for enhancing resilience and well-being among female college students .", "fifty-two students were randomly assigned to either an intervention designed to teach skills of self-compassion ( n = @ ) or an active control group intervention in which general time management skills were taught ( n = @ ) .", "both interventions comprised @ group meetings held over @ weeks .", "to measure resilience and well-being gains , participants filled out a number of questionnaires before and after the intervention .", "results showed that the self-compassion intervention led to significantly greater increases in self-compassion , mindfulness , optimism , and self-efficacy , as well as significantly greater decreases in rumination in comparison to the active control intervention .", "whereas both interventions increased life satisfaction and connectedness , no differences were found for worry and mood .", "these findings suggest that a brief self-compassion intervention has potential for improving student resilience and well-being ." ]
the present study investigated the effectiveness of a newly developed @-week self-compassion group intervention for enhancing resilience and well-being among female college students . fifty-two students were randomly assigned to either an intervention designed to teach skills of self-compassion ( n = @ ) or an active control group intervention in which general time management skills were taught ( n = @ ) . both interventions comprised @ group meetings held over @ weeks . to measure resilience and well-being gains , participants filled out a number of questionnaires before and after the intervention . results showed that the self-compassion intervention led to significantly greater increases in self-compassion , mindfulness , optimism , and self-efficacy , as well as significantly greater decreases in rumination in comparison to the active control intervention . whereas both interventions increased life satisfaction and connectedness , no differences were found for worry and mood . these findings suggest that a brief self-compassion intervention has potential for improving student resilience and well-being .
24,691,680
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "gram-negative organisms are a major health care concern with increasing prevalence of infection and community spread .", "our primary aim was to characterize the transmission dynamics of frequently encountered gram-negative bacteria in the anesthesia work area environment ( awe ) .", "our secondary aim was to examine links between these transmission events and @-day postoperative health care-associated infections ( hcais ) .", "gram-negative isolates obtained from the awe ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at @ major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .", "the top @ frequently encountered genera were subjected to antibiotic disk diffusion sensitivity to identify epidemiologically related transmission events .", "complete multivariable logistic regression analysis and binomial tests of proportion were then used to examine the relative contributions of reservoirs of origin and within - and between-case modes of transmission , respectively , to epidemiologically related transmission events .", "analyses were conducted with and without the inclusion of duplicate transmission events of the same genera occurring in a given study unit ( first and second case of the day in each operating room observed ) to examine the potential effect of statistical dependency .", "transmitted isolates were compared by pulsed-field gel electrophoresis to disease-causing bacteria for @-day postoperative hcais .", "the top @ frequently encountered gram-negative genera included acinetobacter , pseudomonas , brevundimonas , enterobacter , and moraxella that together accounted for @ % ( @/@ ) of possible transmission events .", "for all isolates , @ % ( @/@ ) of possible transmission events were identified by antibiotic susceptibility patterns as epidemiologically related and underwent further study of transmission dynamics .", "there were @ duplicates involving within - and between-case transmission events .", "thus , approximately @ % ( @/@ ) of isolates excluding duplicates were considered epidemiologically related .", "contaminated provider hand reservoirs were less likely ( all isolates , odds ratio @ , @ % confidence interval @-@ @ , p = @ ; without duplicate events , odds ratio @ , @ % confidence interval @-@ @ , p = @ ) than contaminated patient or environmental sites to serve as the reservoir of origin for epidemiologically related transmission events .", "within - and between-case modes of gram-negative bacilli transmission occurred at similar rates ( all isolates , @ % between-case , @ % within-case , binomial p value @ ; without duplicates , @ % between-case , @ % within-case , binomial p value @ ) .", "overall , @ % ( @/@ ) of patients suffered from hcais and had an intraoperative exposure to gram-negative isolates .", "in @ % ( @/@ ) of those patients , gram-negative bacteria were linked by pulsed-field gel electrophoresis to the causative organism of infection .", "patient and provider hands were identified as the reservoirs of origin and the environment confirmed as a vehicle for between-case transmission events linked to hcais .", "between - and within-case awe gram-negative bacterial transmission occurs frequently and is linked by pulsed-field gel electrophoresis to @-day postoperative infections .", "provider hands are less likely than contaminated environmental or patient skin surfaces to serve as the reservoir of origin for transmission events ." ]
gram-negative organisms are a major health care concern with increasing prevalence of infection and community spread . our primary aim was to characterize the transmission dynamics of frequently encountered gram-negative bacteria in the anesthesia work area environment ( awe ) . our secondary aim was to examine links between these transmission events and @-day postoperative health care-associated infections ( hcais ) . gram-negative isolates obtained from the awe ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at @ major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) . the top @ frequently encountered genera were subjected to antibiotic disk diffusion sensitivity to identify epidemiologically related transmission events . complete multivariable logistic regression analysis and binomial tests of proportion were then used to examine the relative contributions of reservoirs of origin and within - and between-case modes of transmission , respectively , to epidemiologically related transmission events . analyses were conducted with and without the inclusion of duplicate transmission events of the same genera occurring in a given study unit ( first and second case of the day in each operating room observed ) to examine the potential effect of statistical dependency . transmitted isolates were compared by pulsed-field gel electrophoresis to disease-causing bacteria for @-day postoperative hcais . the top @ frequently encountered gram-negative genera included acinetobacter , pseudomonas , brevundimonas , enterobacter , and moraxella that together accounted for @ % ( @/@ ) of possible transmission events . for all isolates , @ % ( @/@ ) of possible transmission events were identified by antibiotic susceptibility patterns as epidemiologically related and underwent further study of transmission dynamics . there were @ duplicates involving within - and between-case transmission events . thus , approximately @ % ( @/@ ) of isolates excluding duplicates were considered epidemiologically related . contaminated provider hand reservoirs were less likely ( all isolates , odds ratio @ , @ % confidence interval @-@ @ , p = @ ; without duplicate events , odds ratio @ , @ % confidence interval @-@ @ , p = @ ) than contaminated patient or environmental sites to serve as the reservoir of origin for epidemiologically related transmission events . within - and between-case modes of gram-negative bacilli transmission occurred at similar rates ( all isolates , @ % between-case , @ % within-case , binomial p value @ ; without duplicates , @ % between-case , @ % within-case , binomial p value @ ) . overall , @ % ( @/@ ) of patients suffered from hcais and had an intraoperative exposure to gram-negative isolates . in @ % ( @/@ ) of those patients , gram-negative bacteria were linked by pulsed-field gel electrophoresis to the causative organism of infection . patient and provider hands were identified as the reservoirs of origin and the environment confirmed as a vehicle for between-case transmission events linked to hcais . between - and within-case awe gram-negative bacterial transmission occurs frequently and is linked by pulsed-field gel electrophoresis to @-day postoperative infections . provider hands are less likely than contaminated environmental or patient skin surfaces to serve as the reservoir of origin for transmission events .
25,790,209
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "health-related quality of life ( hrqol ) is an important indicator of well-being in patients with epilepsy .", "when assessing changes in hrqol over time , some of the changes observed may be due to the patients ' change in the internal standards , value , or meaning that they attribute to the hrqol domain being measured , rather than actual change , a phenomenon known as response shift .", "response shifts are increasingly recognized as an important explanation for the seemingly paradoxical or counterintuitive hrqol results often observed in chronic conditions .", "we investigated the presence of changing values ( reprioritization response shift ) in data from a surgical randomized controlled trial of patients with temporal lobe epilepsy ( tle ) .", "eighty patients with tle , who were randomized to surgical and medical treatment , provided data on the epilepsy-specific @-item quality of life in epilepsy ( qolie-@ ) questionnaire at baseline and @ year after randomization .", "reprioritization response shift among the seven qolie-@ domains was assessed using changes in the relative importance weights derived from logistic regression and discriminant analysis .", "the relative importance analysis showed a statistically significant increase over time in the importance of social function , but a significant decrease in the relative importance of seizure worry .", "there were no significant changes in the relative importance of the remaining five domains in distinguishing between surgical and medical group over time .", "patients that receive surgical treatment are more likely to experience a decrease in the valuation of seizure worry and an increase in the value of social function as compared to patients who are medically treated .", "changes in expectation about seizure freedom and social function may confound the assessment of longitudinal change on these outcomes , and highlight the importance of assessing response shift and the limitations of assessing hrqol at a single point in time or without a control group .", "a powerpoint slide summarizing this article is available for download in the supporting information section here ." ]
health-related quality of life ( hrqol ) is an important indicator of well-being in patients with epilepsy . when assessing changes in hrqol over time , some of the changes observed may be due to the patients ' change in the internal standards , value , or meaning that they attribute to the hrqol domain being measured , rather than actual change , a phenomenon known as response shift . response shifts are increasingly recognized as an important explanation for the seemingly paradoxical or counterintuitive hrqol results often observed in chronic conditions . we investigated the presence of changing values ( reprioritization response shift ) in data from a surgical randomized controlled trial of patients with temporal lobe epilepsy ( tle ) . eighty patients with tle , who were randomized to surgical and medical treatment , provided data on the epilepsy-specific @-item quality of life in epilepsy ( qolie-@ ) questionnaire at baseline and @ year after randomization . reprioritization response shift among the seven qolie-@ domains was assessed using changes in the relative importance weights derived from logistic regression and discriminant analysis . the relative importance analysis showed a statistically significant increase over time in the importance of social function , but a significant decrease in the relative importance of seizure worry . there were no significant changes in the relative importance of the remaining five domains in distinguishing between surgical and medical group over time . patients that receive surgical treatment are more likely to experience a decrease in the valuation of seizure worry and an increase in the value of social function as compared to patients who are medically treated . changes in expectation about seizure freedom and social function may confound the assessment of longitudinal change on these outcomes , and highlight the importance of assessing response shift and the limitations of assessing hrqol at a single point in time or without a control group . a powerpoint slide summarizing this article is available for download in the supporting information section here .
24,965,190
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "longevity results in changes to patterns of health , with an increased prevalence of chronic diseases .", "parkinson 's disease ( pd ) is described as a progressive neurodegenerative disease related to age that influences quality of life ( qol ) and leads to depression .", "the study intended to assess changes in qol and depression in older adults with pd through use of feldenkrais method-based exercise .", "the study was a controlled , blinded , and randomized clinical trial .", "the study occurred at the university hospital of the federal university of sergipe in aracaju , sergipe , brazil .", "participants were @ patients , aged between @ and @ y , with idiopathic pd , who signed an informed consent form and were randomly assigned to @ groups : treatment and control .", "the treatment group underwent @ sessions of an exercise program based on the feldenkrais method .", "the control group received educational lectures during this period .", "the treatment group 's @ sessions , given @ / wk on alternate days and lasting @ min , were conducted in an appropriate room at the hospital .", "two surveys , the parkinson 's disease quality of life ( pdql ) questionnaire and the beck depression inventory ( bdi ) , were administered before and after the sessions for both groups .", "after the exercises based on the feldenkrais method , the treated group showed improvement in qol scores ( p = @ ) as well as a reduction in the level of depression ( p = @ ) compared with the control group .", "the findings in the current study indicate that it is likely that the practice of a program based on the feldenkrais method can contribute greatly to the qol of patients with pd , suggesting the importance of interventions that promote wellness for this population ." ]
longevity results in changes to patterns of health , with an increased prevalence of chronic diseases . parkinson 's disease ( pd ) is described as a progressive neurodegenerative disease related to age that influences quality of life ( qol ) and leads to depression . the study intended to assess changes in qol and depression in older adults with pd through use of feldenkrais method-based exercise . the study was a controlled , blinded , and randomized clinical trial . the study occurred at the university hospital of the federal university of sergipe in aracaju , sergipe , brazil . participants were @ patients , aged between @ and @ y , with idiopathic pd , who signed an informed consent form and were randomly assigned to @ groups : treatment and control . the treatment group underwent @ sessions of an exercise program based on the feldenkrais method . the control group received educational lectures during this period . the treatment group 's @ sessions , given @ / wk on alternate days and lasting @ min , were conducted in an appropriate room at the hospital . two surveys , the parkinson 's disease quality of life ( pdql ) questionnaire and the beck depression inventory ( bdi ) , were administered before and after the sessions for both groups . after the exercises based on the feldenkrais method , the treated group showed improvement in qol scores ( p = @ ) as well as a reduction in the level of depression ( p = @ ) compared with the control group . the findings in the current study indicate that it is likely that the practice of a program based on the feldenkrais method can contribute greatly to the qol of patients with pd , suggesting the importance of interventions that promote wellness for this population .
25,599,428
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , is being developed as an adjunct for surgical hemostasis .", "safety and efficacy of fibrocaps applied directly or by spray device , in combination with gelatin sponge , was compared with that of gelatin sponge-alone in two randomized , single-blind controlled trials : fc-@ us ( united states ) and fc-@ nl ( the netherlands ) .", "a total of @ adult patients were randomized ( fibrocaps : n = @ -lsb- fc-@ us -rsb- , n = @ -lsb- fc-@ nl -rsb- ; gelatin sponge alone : n = @ -lsb- fc-@ us -rsb- , n = @ -lsb- fc-@ nl ) .", "one bleeding site was treated during a surgical procedure ( n = @ ) .", "time to hemostasis ( primary end point ) was measured , with a @-d safety follow-up .", "four surgical indications included hepatic resection ( n = @ ) , spinal procedures ( n = @ ) , peripheral vascular procedures ( n = @ ) , and soft tissue dissection ( n = @ ) .", "mean ( standard deviation ) time to hemostasis was significantly shorter after fibrocaps treatment than after gelatin sponge alone ( fc-@ us : @ -lsb- @ -rsb- versus @ min -lsb- @ -rsb- , p < @ ; fc-@ nl : @ -lsb- @ -rsb- versus @ min -lsb- @ -rsb- , p = @ ) .", "the incidence of hemostasis was greater after fibrocaps compared with that of gelatin sponge alone within @min ( fc-@ us : @ % versus @ % , p < @ ; fc-@ nl : @ % versus @ % , p = @ ) , @min ( @ % versus @ % , p = @ ; @ % versus @ % , p = @ ) , and @min ( @ % versus @ % , p = @ ; @ % versus @ % , p = @ ) .", "adverse events were consistent with surgical procedures performed and patients ' underlying diseases and generally similar between treatment arms ; most were mild or moderate in severity .", "non-neutralizing antithrombin antibodies were detected in @ % of fibrocaps-treated patients on day@ .", "fibrocaps had good safety and efficacy profiles , supporting continuing clinical development as a novel fibrin sealant ." ]
fibrocaps , a ready-to-use , dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen , is being developed as an adjunct for surgical hemostasis . safety and efficacy of fibrocaps applied directly or by spray device , in combination with gelatin sponge , was compared with that of gelatin sponge-alone in two randomized , single-blind controlled trials : fc-@ us ( united states ) and fc-@ nl ( the netherlands ) . a total of @ adult patients were randomized ( fibrocaps : n = @ -lsb- fc-@ us -rsb- , n = @ -lsb- fc-@ nl -rsb- ; gelatin sponge alone : n = @ -lsb- fc-@ us -rsb- , n = @ -lsb- fc-@ nl ) . one bleeding site was treated during a surgical procedure ( n = @ ) . time to hemostasis ( primary end point ) was measured , with a @-d safety follow-up . four surgical indications included hepatic resection ( n = @ ) , spinal procedures ( n = @ ) , peripheral vascular procedures ( n = @ ) , and soft tissue dissection ( n = @ ) . mean ( standard deviation ) time to hemostasis was significantly shorter after fibrocaps treatment than after gelatin sponge alone ( fc-@ us : @ -lsb- @ -rsb- versus @ min -lsb- @ -rsb- , p < @ ; fc-@ nl : @ -lsb- @ -rsb- versus @ min -lsb- @ -rsb- , p = @ ) . the incidence of hemostasis was greater after fibrocaps compared with that of gelatin sponge alone within @min ( fc-@ us : @ % versus @ % , p < @ ; fc-@ nl : @ % versus @ % , p = @ ) , @min ( @ % versus @ % , p = @ ; @ % versus @ % , p = @ ) , and @min ( @ % versus @ % , p = @ ; @ % versus @ % , p = @ ) . adverse events were consistent with surgical procedures performed and patients ' underlying diseases and generally similar between treatment arms ; most were mild or moderate in severity . non-neutralizing antithrombin antibodies were detected in @ % of fibrocaps-treated patients on day@ . fibrocaps had good safety and efficacy profiles , supporting continuing clinical development as a novel fibrin sealant .
25,586,331
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "refraining from breastfeeding to prevent hiv transmission has been associated with increased morbidity and mortality in hiv-exposed african infants .", "the objective was to assess risks of common and serious infectious morbidity by feeding mode in hiv-exposed , uninfected infants @ mo of age with special attention to the issue of reverse causality .", "hiv-infected pregnant women from @ sites in burkina faso , kenya , and south africa were enrolled in the prevention of mother-to-child transmission kesho bora trial and counseled to either breastfeed exclusively and cease by @ mo postpartum or formula feed exclusively .", "maternal-reported morbidity ( fever , diarrhea , and vomiting ) and serious infectious events ( sies ) ( gastroenteritis and lower respiratory tract infections ) were investigated for @ infants for @ age periods ( @-@ @ and @-@ mo ) by using generalized linear mixed models with breastfeeding as a time-dependent variable and adjustment for study site , maternal education , economic level , and cotrimoxazole prophylaxis .", "reported morbidity was not significantly higher in nonbreastfed compared with breastfed infants -lsb- or : @ ( @ % ci : @ , @ ) and @ ( @ , @ ) at @-@ @ and @-@ mo of age , respectively -rsb- .", "between @ and @ mo of age , never-breastfed infants had increased risks of morbidity compared with those of infants who were exclusively breastfed ( or : @ ; @ % ci : @ , @ ; p = @ ) .", "the adjusted excess risk of sies in nonbreastfed infants was large between @ and @ mo ( or : @ ; @ % ci : @ , @ ; p = @ ) .", "between @ and @ mo , the or for sies was sensitive to the timing of breastfeeding status , i.e. , @ ( @ % ci : @ , @ ; p = @ ) when defined at end of monthly intervals and @ ( @ % ci : @ , @ ; p = @ ) when defined at the beginning of intervals .", "of @ sies , @ mothers reported changes in feeding mode during the sie although none of the mothers ceased breastfeeding completely .", "not breastfeeding was associated with increased risk of serious infections especially between @ and @ mo of age .", "the randomized controlled trial component of the kesho bora study was registered at current controlled trials ( www.controlled-trials.com ) as isrctn@ ." ]
refraining from breastfeeding to prevent hiv transmission has been associated with increased morbidity and mortality in hiv-exposed african infants . the objective was to assess risks of common and serious infectious morbidity by feeding mode in hiv-exposed , uninfected infants @ mo of age with special attention to the issue of reverse causality . hiv-infected pregnant women from @ sites in burkina faso , kenya , and south africa were enrolled in the prevention of mother-to-child transmission kesho bora trial and counseled to either breastfeed exclusively and cease by @ mo postpartum or formula feed exclusively . maternal-reported morbidity ( fever , diarrhea , and vomiting ) and serious infectious events ( sies ) ( gastroenteritis and lower respiratory tract infections ) were investigated for @ infants for @ age periods ( @-@ @ and @-@ mo ) by using generalized linear mixed models with breastfeeding as a time-dependent variable and adjustment for study site , maternal education , economic level , and cotrimoxazole prophylaxis . reported morbidity was not significantly higher in nonbreastfed compared with breastfed infants -lsb- or : @ ( @ % ci : @ , @ ) and @ ( @ , @ ) at @-@ @ and @-@ mo of age , respectively -rsb- . between @ and @ mo of age , never-breastfed infants had increased risks of morbidity compared with those of infants who were exclusively breastfed ( or : @ ; @ % ci : @ , @ ; p = @ ) . the adjusted excess risk of sies in nonbreastfed infants was large between @ and @ mo ( or : @ ; @ % ci : @ , @ ; p = @ ) . between @ and @ mo , the or for sies was sensitive to the timing of breastfeeding status , i.e. , @ ( @ % ci : @ , @ ; p = @ ) when defined at end of monthly intervals and @ ( @ % ci : @ , @ ; p = @ ) when defined at the beginning of intervals . of @ sies , @ mothers reported changes in feeding mode during the sie although none of the mothers ceased breastfeeding completely . not breastfeeding was associated with increased risk of serious infections especially between @ and @ mo of age . the randomized controlled trial component of the kesho bora study was registered at current controlled trials ( www.controlled-trials.com ) as isrctn@ .
25,411,291
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]