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[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]
[ "the emergence of hiv as a chronic condition means that people living with hiv are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments .", "this paper describes the design and evaluation of positive outlook , an online program aiming to enhance the self-management skills of gay men living with hiv .", "this study is designed as a randomised controlled trial in which men living with hiv in australia will be assigned to either an intervention group or usual care control group .", "the intervention group will participate in the online group program ` positive outlook ' .", "the program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with hiv in daily life .", "participants will access the program for a minimum of @ minutes per week over seven weeks .", "primary outcomes are domain specific self-efficacy , hiv related quality of life , and outcomes of health education .", "secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to hiv ; and social support .", "data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at @ week follow-up .", "results of the positive outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with hiv .", "actrn@ ." ]
the emergence of hiv as a chronic condition means that people living with hiv are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments . this paper describes the design and evaluation of positive outlook , an online program aiming to enhance the self-management skills of gay men living with hiv . this study is designed as a randomised controlled trial in which men living with hiv in australia will be assigned to either an intervention group or usual care control group . the intervention group will participate in the online group program ` positive outlook ' . the program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with hiv in daily life . participants will access the program for a minimum of @ minutes per week over seven weeks . primary outcomes are domain specific self-efficacy , hiv related quality of life , and outcomes of health education . secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to hiv ; and social support . data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at @ week follow-up . results of the positive outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with hiv . actrn@ .
24,491,034
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to evaluate the efficacy , safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy .", "a total of @ patients suffering from thyroid ophthalmopathy were included in this study .", "patients were randomized into two groups : group i included @ patients treated with oral prednisolone and group ii included @ patients treated with peribulbar triamcinolone orbital injection .", "only @ patients in both groups ( @ female and @ male ) completed the study .", "both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases .", "mean exophthalmometry value before treatment was @ @ mm that decreased to @ @ mm in group i , compared with @ @ mm that decreased to @ @ mm in group ii .", "mean initial clinical activity score was @ @ and @ @ for group i and group ii before treatment , respectively , which dropped to @ @ and @ @ , @ months after treatment , respectively .", "there was no change in the best-corrected visual acuity in both groups .", "there was an increase in body weight , blood sugar , blood pressure and gastritis in group i in @ % , @ % , @ % and @ % , respectively , compared with @ % , @ % , @ % and @ % in group ii .", "no adverse local side effects were observed in group ii .", "orbital steroid injection for thyroid-related ophthalmopathy is effective and safe .", "it eliminates the adverse reactions associated with oral corticosteroid use ." ]
the aim of this study was to evaluate the efficacy , safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy . a total of @ patients suffering from thyroid ophthalmopathy were included in this study . patients were randomized into two groups : group i included @ patients treated with oral prednisolone and group ii included @ patients treated with peribulbar triamcinolone orbital injection . only @ patients in both groups ( @ female and @ male ) completed the study . both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases . mean exophthalmometry value before treatment was @ @ mm that decreased to @ @ mm in group i , compared with @ @ mm that decreased to @ @ mm in group ii . mean initial clinical activity score was @ @ and @ @ for group i and group ii before treatment , respectively , which dropped to @ @ and @ @ , @ months after treatment , respectively . there was no change in the best-corrected visual acuity in both groups . there was an increase in body weight , blood sugar , blood pressure and gastritis in group i in @ % , @ % , @ % and @ % , respectively , compared with @ % , @ % , @ % and @ % in group ii . no adverse local side effects were observed in group ii . orbital steroid injection for thyroid-related ophthalmopathy is effective and safe . it eliminates the adverse reactions associated with oral corticosteroid use .
20,497,432
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain , nausea and vomiting in pediatric ambulatory tonsillectomy .", "families , whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy , were randomly assigned to the study groups ( n = @ ; @ families in each group ) .", "the intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition , and the control group the fasting instructions according to the hospital 's standard procedure .", "the level of postoperative pain and nausea was scored in the postanesthesia care unit ( pacu ) during the first postoperative hour , as well as at @ , @ , @ and @h postoperatively .", "the first scoring in pacu was performed by the attending nurse with a @-@ scale .", "the rest of the estimations were made independently and simultaneously by the children using a vas scale , and by the parents using a @-@ scale .", "the children in the control group were in more pain in the pacu than the children in the intervention group , and the difference between the groups was statistically significant ( p = @ ) .", "all pain scores , according to the children and the parents , increased after the surgery .", "in both groups the highest score values were found at home @h after surgery , and no significant difference was found between the study groups .", "on the first postoperative morning , the children in the control group were in pain ( p = @ ) .", "the children did not have significant nausea in the pacu , but the nausea increased postoperatively .", "four hours after surgery the children were most nauseous according to all estimations ( @ % , n = @ ) .", "more than half of the children vomited and most vomited clotted blood .", "nausea and vomiting decreased during the evening of the surgery , but six children vomited the next morning , four of them vomited blood .", "the incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant .", "however , preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting .", "the preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting ." ]
the aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain , nausea and vomiting in pediatric ambulatory tonsillectomy . families , whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy , were randomly assigned to the study groups ( n = @ ; @ families in each group ) . the intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition , and the control group the fasting instructions according to the hospital 's standard procedure . the level of postoperative pain and nausea was scored in the postanesthesia care unit ( pacu ) during the first postoperative hour , as well as at @ , @ , @ and @h postoperatively . the first scoring in pacu was performed by the attending nurse with a @-@ scale . the rest of the estimations were made independently and simultaneously by the children using a vas scale , and by the parents using a @-@ scale . the children in the control group were in more pain in the pacu than the children in the intervention group , and the difference between the groups was statistically significant ( p = @ ) . all pain scores , according to the children and the parents , increased after the surgery . in both groups the highest score values were found at home @h after surgery , and no significant difference was found between the study groups . on the first postoperative morning , the children in the control group were in pain ( p = @ ) . the children did not have significant nausea in the pacu , but the nausea increased postoperatively . four hours after surgery the children were most nauseous according to all estimations ( @ % , n = @ ) . more than half of the children vomited and most vomited clotted blood . nausea and vomiting decreased during the evening of the surgery , but six children vomited the next morning , four of them vomited blood . the incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant . however , preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting . the preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting .
19,062,107
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to explore the effects of gengnianle ( gnl , also called perimenopausal depression relieving formula ) , a defined formula of chinese medicinal herbs in relieving perimenopausal depression in chinese women .", "between september @ and april @ , @ chinese women were randomized into a gnl group ( n = @ ) and a control group which received tibolone ( n = @ ) using a randomization chart .", "depression was rated with the @-item hamilton depression scale ( hamd ) .", "the serum levels of follicle stimulating hormone ( fsh ) , luteinizing hormone ( lh ) , and estradiol ( e ( @ ) ) were detected before and after the treatment .", "after @ weeks of treatment , hamd scores in both groups decreased significantly ( p < @ ) with no significant difference between the groups ( p > @ ) .", "the levels of fsh decreased significantly and the level of e ( @ ) increased significantly in both groups , and they changed more in the control group .", "no side-effect of treatment was reported in either group during treatment .", "the chinese medicinal formula gnl showed promise in relieving perimenopausal depression and merits further study ." ]
to explore the effects of gengnianle ( gnl , also called perimenopausal depression relieving formula ) , a defined formula of chinese medicinal herbs in relieving perimenopausal depression in chinese women . between september @ and april @ , @ chinese women were randomized into a gnl group ( n = @ ) and a control group which received tibolone ( n = @ ) using a randomization chart . depression was rated with the @-item hamilton depression scale ( hamd ) . the serum levels of follicle stimulating hormone ( fsh ) , luteinizing hormone ( lh ) , and estradiol ( e ( @ ) ) were detected before and after the treatment . after @ weeks of treatment , hamd scores in both groups decreased significantly ( p < @ ) with no significant difference between the groups ( p > @ ) . the levels of fsh decreased significantly and the level of e ( @ ) increased significantly in both groups , and they changed more in the control group . no side-effect of treatment was reported in either group during treatment . the chinese medicinal formula gnl showed promise in relieving perimenopausal depression and merits further study .
19,769,482
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "topical formulations of nonsteroidal anti-inflammatory drugs ( nsaids ) are generally considered to be safer alternatives to oral nsaids due to lower systemic absorption .", "we conducted randomized , crossover studies that compared the pharmacokinetics ( pk ) , bioequivalence and safety of topical diclofenac sodium @ % twice daily ( bid ) , diclofenac sodium @ % four times daily ( qid ) and oral diclofenac sodium in healthy subjects .", "the results of three bioequivalence studies are reviewed .", "healthy adult subjects ( n = @ ) applied topical diclofenac sodium @ % solution ( @ mg/@ ml ) bid ; or @ % solution ( @ mg/@ drops ) qid to each knee for @ consecutive days separated by a washout period .", "subjects ( n = @ ) in one study also received oral diclofenac sodium @ mg bid for @ days .", "plasma diclofenac concentrations were determined from serial blood samples collected on days @ and @ ( steady state ) , and diclofenac pk parameters were estimated by noncompartmental methods .", "the studies demonstrated comparable bioequivalence between the @ % and @ % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately @ % less ) .", "daily systemic exposure was comparable between the two formulations with only a @ % difference in the aucss ( @-@ ) ( p = @ ) .", "furthermore , both topical solutions demonstrated delayed elimination with a t ( @/@ ) of @ - to @-fold longer , as compared to oral diclofenac .", "the @ % solution provided more consistent dosing relative to the @ % solution when comparing aucss ( @-@ ) and cmaxss across studies .", "mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac .", "the steady-state pk profile of topical diclofenac @ % solution administered bid is similar to that of the @ % solution administered qid .", "systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration .", "( study @ was registered with clinicaltrials.gov ; nct@ ; https://clinicaltrials.gov/ct@/results?term=@&search=search ) ." ]
topical formulations of nonsteroidal anti-inflammatory drugs ( nsaids ) are generally considered to be safer alternatives to oral nsaids due to lower systemic absorption . we conducted randomized , crossover studies that compared the pharmacokinetics ( pk ) , bioequivalence and safety of topical diclofenac sodium @ % twice daily ( bid ) , diclofenac sodium @ % four times daily ( qid ) and oral diclofenac sodium in healthy subjects . the results of three bioequivalence studies are reviewed . healthy adult subjects ( n = @ ) applied topical diclofenac sodium @ % solution ( @ mg/@ ml ) bid ; or @ % solution ( @ mg/@ drops ) qid to each knee for @ consecutive days separated by a washout period . subjects ( n = @ ) in one study also received oral diclofenac sodium @ mg bid for @ days . plasma diclofenac concentrations were determined from serial blood samples collected on days @ and @ ( steady state ) , and diclofenac pk parameters were estimated by noncompartmental methods . the studies demonstrated comparable bioequivalence between the @ % and @ % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately @ % less ) . daily systemic exposure was comparable between the two formulations with only a @ % difference in the aucss ( @-@ ) ( p = @ ) . furthermore , both topical solutions demonstrated delayed elimination with a t ( @/@ ) of @ - to @-fold longer , as compared to oral diclofenac . the @ % solution provided more consistent dosing relative to the @ % solution when comparing aucss ( @-@ ) and cmaxss across studies . mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac . the steady-state pk profile of topical diclofenac @ % solution administered bid is similar to that of the @ % solution administered qid . systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration . ( study @ was registered with clinicaltrials.gov ; nct@ ; https://clinicaltrials.gov/ct@/results?term=@&search=search ) .
26,077,436
[ "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "no long-term studies have been reported on the effect of training programs on driving after stroke .", "the authors ' primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at @ years poststroke .", "a second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving .", "in a previously reported randomized controlled trial , @ stroke survivors received @ hours of simulator training ( n = @ ) or cognitive therapy ( n = @ ) .", "in this @-year follow-up study , @ participants were reassessed .", "fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; @ participants ( simulator group , n = @ ; cognitive group , n = @ ) completed all assessments .", "the primary outcome measures were fitness-to-drive decision and current driving status .", "the authors found that @ years after stroke , @ of @ participants ( @ % ) in the simulator group were considered fit to drive , compared with @ of @ ( @ % ) in the cognitive group ( p = @ ) ; @ of @ ( @ % ) participants were driving .", "current drivers were younger ( p = @ ) , had higher barthel scores ( p = @ ) , had less comorbidity ( p = @ ) , and were less severely depressed ( p = @ ) than those who gave up driving .", "the advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at @ months poststroke , had faded @ years later .", "poststroke drivers were younger and less severely affected and depressed than nondrivers ." ]
no long-term studies have been reported on the effect of training programs on driving after stroke . the authors ' primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at @ years poststroke . a second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving . in a previously reported randomized controlled trial , @ stroke survivors received @ hours of simulator training ( n = @ ) or cognitive therapy ( n = @ ) . in this @-year follow-up study , @ participants were reassessed . fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; @ participants ( simulator group , n = @ ; cognitive group , n = @ ) completed all assessments . the primary outcome measures were fitness-to-drive decision and current driving status . the authors found that @ years after stroke , @ of @ participants ( @ % ) in the simulator group were considered fit to drive , compared with @ of @ ( @ % ) in the cognitive group ( p = @ ) ; @ of @ ( @ % ) participants were driving . current drivers were younger ( p = @ ) , had higher barthel scores ( p = @ ) , had less comorbidity ( p = @ ) , and were less severely depressed ( p = @ ) than those who gave up driving . the advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at @ months poststroke , had faded @ years later . poststroke drivers were younger and less severely affected and depressed than nondrivers .
20,656,965
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the potential of insecticide-treated bednets ( itns ) to contribute to child survival has been well documented in randomised controlled trials .", "itn coverage has increased rapidly in kenya from @ % in @ to @ % in @ .", "we aimed to assess the extent to which this investment has led to improvements in child survival .", "a dynamic cohort of about @ children aged @-@ months were enumerated three times at yearly intervals in @ rural clusters located in four districts of kenya .", "the effect of itn use on mortality was assessed with poisson regression to take account of potential effect-modifying and confounding covariates .", "@ children died over @ years .", "overall mortality rates were much the same in the first and second years of the study ( @ per @ person-years in the first year and @ per @ person-years in the second ) .", "after adjustment for age , time period , and a number of other possible confounding variables , itn use was associated with a @ % reduction in mortality ( mortality rate ratio @ , @ % ci @-@ @ ; p = @ ) .", "this level of protection corresponds to about seven deaths averted for every @ itns distributed .", "a combined approach of social marketing followed by mass free distribution of itns translated into child survival effects that are comparable with those seen in previous randomised controlled trials ." ]
the potential of insecticide-treated bednets ( itns ) to contribute to child survival has been well documented in randomised controlled trials . itn coverage has increased rapidly in kenya from @ % in @ to @ % in @ . we aimed to assess the extent to which this investment has led to improvements in child survival . a dynamic cohort of about @ children aged @-@ months were enumerated three times at yearly intervals in @ rural clusters located in four districts of kenya . the effect of itn use on mortality was assessed with poisson regression to take account of potential effect-modifying and confounding covariates . @ children died over @ years . overall mortality rates were much the same in the first and second years of the study ( @ per @ person-years in the first year and @ per @ person-years in the second ) . after adjustment for age , time period , and a number of other possible confounding variables , itn use was associated with a @ % reduction in mortality ( mortality rate ratio @ , @ % ci @-@ @ ; p = @ ) . this level of protection corresponds to about seven deaths averted for every @ itns distributed . a combined approach of social marketing followed by mass free distribution of itns translated into child survival effects that are comparable with those seen in previous randomised controlled trials .
17,889,242
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cortical stimulation mapping ( csm ) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy .", "visual naming alone may not identify all language sites in resection-prone areas , prompting additional tasks for comprehensive language mapping .", "to demonstrate word-finding distinctions between visual , auditory , and reading modalities during csm and the percentage of modality-specific language sites within dominant hemisphere subregions .", "twenty-eight patients with epilepsy underwent csm by the use of visual , auditory , and sentence-completion tasks .", "hierarchical logistic regression analyzed errors to identify language sites and provide modality-specific percentages within subregions .", "the percentage of sites classified as language sites based on auditory naming was twice as high in anterior temporal regions compared with visual naming , marginally higher in posterior temporal areas , and comparable in parietal regions .", "sentence completion was comparable to visual and auditory naming in parietal regions and lower in most temporal areas .", "of @ sites tested with both visual and auditory naming , @ sites were distinctly auditory , whereas @ sites were distinctly visual .", "the remaining sites overlapped .", "distinct cortical areas were found for distinct input modalities , with language sites in anterior tip regions found most often by using auditory naming .", "the vulnerability of anterior temporal tip regions to resection in this population and distinct sites for each modality suggest that a multimodality approach may be needed to spare crucial language sites , if sparing those sites can be shown to significantly reduce the rate of postoperative language deficits without sacrificing seizure control ." ]
cortical stimulation mapping ( csm ) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy . visual naming alone may not identify all language sites in resection-prone areas , prompting additional tasks for comprehensive language mapping . to demonstrate word-finding distinctions between visual , auditory , and reading modalities during csm and the percentage of modality-specific language sites within dominant hemisphere subregions . twenty-eight patients with epilepsy underwent csm by the use of visual , auditory , and sentence-completion tasks . hierarchical logistic regression analyzed errors to identify language sites and provide modality-specific percentages within subregions . the percentage of sites classified as language sites based on auditory naming was twice as high in anterior temporal regions compared with visual naming , marginally higher in posterior temporal areas , and comparable in parietal regions . sentence completion was comparable to visual and auditory naming in parietal regions and lower in most temporal areas . of @ sites tested with both visual and auditory naming , @ sites were distinctly auditory , whereas @ sites were distinctly visual . the remaining sites overlapped . distinct cortical areas were found for distinct input modalities , with language sites in anterior tip regions found most often by using auditory naming . the vulnerability of anterior temporal tip regions to resection in this population and distinct sites for each modality suggest that a multimodality approach may be needed to spare crucial language sites , if sparing those sites can be shown to significantly reduce the rate of postoperative language deficits without sacrificing seizure control .
23,615,091
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine if suppressive acyclovir therapy given to term gravidas experiencing a first episode of genital herpes simplex virus ( hsv ) - infection during pregnancy decreases the need for cesarean delivery for that indication .", "forty-six pregnant women with first episodes of genital herpes during pregnancy were randomly assigned to receive oral acyclovir @ mg or placebo , three times per day , from @ weeks ' gestation until delivery as part of a prospective , double-blind trial .", "herpes simplex virus cultures were obtained when patients presented for delivery .", "vaginal delivery was permitted if no clinical recurrence was present ; otherwise , a cesarean was performed .", "neonatal hsv cultures were obtained and infants were followed-up clinically .", "none of the @ patients treated with acyclovir and nine of @ ( @ % ) treated with placebo had clinical evidence of recurrent genital herpes at delivery ( odds ratio [ or ] @ , @ % confidence interval [ ci ] @-@ @ ; p = @ ) .", "no woman treated with acyclovir had a cesarean for herpes , compared with nine of @ ( @ % ) of those treated with placebo ( or @ , ci @-@ @ ; p = @ ) .", "no patient in either treatment group experienced asymptomatic genital viral shedding at delivery .", "no neonate had evidence of herpes infection or adverse effects from acyclovir .", "suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital hsv occurred during pregnancy .", "suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus ." ]
to determine if suppressive acyclovir therapy given to term gravidas experiencing a first episode of genital herpes simplex virus ( hsv ) - infection during pregnancy decreases the need for cesarean delivery for that indication . forty-six pregnant women with first episodes of genital herpes during pregnancy were randomly assigned to receive oral acyclovir @ mg or placebo , three times per day , from @ weeks ' gestation until delivery as part of a prospective , double-blind trial . herpes simplex virus cultures were obtained when patients presented for delivery . vaginal delivery was permitted if no clinical recurrence was present ; otherwise , a cesarean was performed . neonatal hsv cultures were obtained and infants were followed-up clinically . none of the @ patients treated with acyclovir and nine of @ ( @ % ) treated with placebo had clinical evidence of recurrent genital herpes at delivery ( odds ratio [ or ] @ , @ % confidence interval [ ci ] @-@ @ ; p = @ ) . no woman treated with acyclovir had a cesarean for herpes , compared with nine of @ ( @ % ) of those treated with placebo ( or @ , ci @-@ @ ; p = @ ) . no patient in either treatment group experienced asymptomatic genital viral shedding at delivery . no neonate had evidence of herpes infection or adverse effects from acyclovir . suppressive acyclovir therapy reduced the need for cesarean for recurrent herpes in women whose first clinical episode of genital hsv occurred during pregnancy . suppressive acyclovir treatment did not increase asymptomatic viral shedding and was not harmful to the term fetus .
8,532,270
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( fungizone ) prepared in a parenteral fat emulsion ( intralipid @ % ) or glucose in hiv patients with candidiasis .", "non-blind randomised controlled trial .", "university hospital ; tertiary clinical care .", "@ hiv positive patients with oral candidiasis .", "amphotericin @ mg/kg/day given on four consecutive days as a one hour infusion dissolved in either @ % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of @ g/l fat emulsion ( amphotericin-fat emulsion ) .", "clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of candidiasis ; and serum concentrations of amphotericin .", "@ patients were enrolled in each group .", "all the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = @ ) or severe chills ( n = @ ) , or both .", "for patients completing the amphotericin-glucose treatment creatine concentration increased by @ mumol/l ; four of seven patients had at least one creatinine value > or = @ mumol/l versus one of @ receiving amphotericin-fat emulsion .", "magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion .", "clinical side effects were noted in @/@ infusions with amphotericin-glucose but @/@ with amphotericin-fat emulsion .", "oral candidiasis score was reduced similarly in both groups .", "serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose .", "clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion .", "preparation is simple and cost effective .", "its efficacy is similar to that of conventional amphotericin ." ]
to compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( fungizone ) prepared in a parenteral fat emulsion ( intralipid @ % ) or glucose in hiv patients with candidiasis . non-blind randomised controlled trial . university hospital ; tertiary clinical care . @ hiv positive patients with oral candidiasis . amphotericin @ mg/kg/day given on four consecutive days as a one hour infusion dissolved in either @ % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of @ g/l fat emulsion ( amphotericin-fat emulsion ) . clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of candidiasis ; and serum concentrations of amphotericin . @ patients were enrolled in each group . all the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = @ ) or severe chills ( n = @ ) , or both . for patients completing the amphotericin-glucose treatment creatine concentration increased by @ mumol/l ; four of seven patients had at least one creatinine value > or = @ mumol/l versus one of @ receiving amphotericin-fat emulsion . magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion . clinical side effects were noted in @/@ infusions with amphotericin-glucose but @/@ with amphotericin-fat emulsion . oral candidiasis score was reduced similarly in both groups . serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose . clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion . preparation is simple and cost effective . its efficacy is similar to that of conventional amphotericin .
1,458,072
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "rate control of atrial fibrillation ( af ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose .", "in this study , we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of n-terminal pro-b-type natriuretic peptide ( nt-probnp ) in patients with permanent af .", "we included @ patients ( mean age @ @ years , @ women ) with permanent af and normal left ventricular function in a randomized , cross-over , investigator-blind study .", "diltiazem @ mg , verapamil @ mg , metoprolol @ mg , and carvedilol @ mg were administered o.d. for @ weeks .", "at baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise .", "the exercise capacity ( peak vo@ ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( p < @ for all ) .", "compared with baseline , treatment with diltiazem and verapamil significantly reduced the nt-probnp levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( p < @ for all ) .", "rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of nt-probnp compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of nt-probnp ." ]
rate control of atrial fibrillation ( af ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose . in this study , we aimed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of n-terminal pro-b-type natriuretic peptide ( nt-probnp ) in patients with permanent af . we included @ patients ( mean age @ @ years , @ women ) with permanent af and normal left ventricular function in a randomized , cross-over , investigator-blind study . diltiazem @ mg , verapamil @ mg , metoprolol @ mg , and carvedilol @ mg were administered o.d. for @ weeks . at baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood samples were obtained at rest and at peak exercise . the exercise capacity ( peak vo@ ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( p < @ for all ) . compared with baseline , treatment with diltiazem and verapamil significantly reduced the nt-probnp levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( p < @ for all ) . rate-reducing treatment with diltiazem or verapamil preserved exercise capacity and reduced levels of nt-probnp compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of nt-probnp .
24,135,831
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive .", "the world health organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries .", "we evaluated these two regimens -- the @-site and the @-site regimens -- in terms of immunogenicity , safety and tolerance in people with category i exposure to rabies .", "eighty-two subjects who had mild category i exposure to rabies were immunized using a purified chick embryo cell vaccine .", "the first regimen given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on days @ , @ and @ and at one site on days @ and @ .", "the second regimen , given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on day @ , at @ sites on day @ and at one site on days @ and @ .", "the mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination .", "the subjects were followed up for @ year .", "both regimens produced adequate neutralizing antibody titres from day @ onwards , though the second regimen produced a more rapid antibody response and significantly higher titres ( p < @ ) on all days tested .", "there were minimal side-effects and both regimens were well tolerated .", "both the @-site and @-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the @-site regimen appears to be more immunogenic .", "the feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in india ." ]
post-exposure prophylaxis for rabies with cell culture vaccines by the conventional intramuscular regimen is very expensive . the world health organization has advocated two cost-effective intradermal regimens with cell culture vaccines for use in developing countries . we evaluated these two regimens -- the @-site and the @-site regimens -- in terms of immunogenicity , safety and tolerance in people with category i exposure to rabies . eighty-two subjects who had mild category i exposure to rabies were immunized using a purified chick embryo cell vaccine . the first regimen given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on days @ , @ and @ and at one site on days @ and @ . the second regimen , given to @ subjects , consisted of intradermal administration of @ ml of vaccine at @ sites on day @ , at @ sites on day @ and at one site on days @ and @ . the mouse neutralization test was used to estimate titres of rabies neutralizing antibody in these subjects on different days after vaccination . the subjects were followed up for @ year . both regimens produced adequate neutralizing antibody titres from day @ onwards , though the second regimen produced a more rapid antibody response and significantly higher titres ( p < @ ) on all days tested . there were minimal side-effects and both regimens were well tolerated . both the @-site and @-site intradermal regimens with purified chick embryo cell vaccine produce adequate levels of neutralizing antibodies but the @-site regimen appears to be more immunogenic . the feasibility of using these cost-effective regimens in routine practice needs to be further evaluated under the field conditions prevalent in india .
11,467,142
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "discrete-choice experiments are based on the premise that any good or service can be described by its characteristics ( or attributes ) , and the extent to which an individual values a good or service depends on the levels of these characteristics .", "little is known about patient preferences for treatment of chronic musculoskeletal pain such as achilles tendinopathy .", "a discrete-choice experiment was conducted in @ adults with a history of achilles tendon pain at the conclusion of a three-arm randomized clinical trial .", "participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions .", "for each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful achilles tendon .", "a mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes .", "a response rate of @ % was achieved .", "a significant positive impact on utility was observed for chance of treatment success .", "a significant negative impact on utility was observed for cost , weeks before exercise can be completed free of pain , chance of side effects ( p = @ ) , and injections as a stand-alone treatment .", "respondents were willing to pay australian dollars ( $ a ) @ ( @ % ci -@ , @ ) for a @ % increase in the chance of treatment success .", "study participants with achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less , has a greater chance of success , has a shorter duration before being able to exercise free of pain , and has less likelihood of side effects .", "on average , participants preferred exercises over injections as a stand-alone treatment .", "further research is required to confirm the findings in patients outside of the trial setting .", "nevertheless , this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to achilles tendinopathy ." ]
discrete-choice experiments are based on the premise that any good or service can be described by its characteristics ( or attributes ) , and the extent to which an individual values a good or service depends on the levels of these characteristics . little is known about patient preferences for treatment of chronic musculoskeletal pain such as achilles tendinopathy . a discrete-choice experiment was conducted in @ adults with a history of achilles tendon pain at the conclusion of a three-arm randomized clinical trial . participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions . for each scenario , participants were asked to choose which option they would prefer if seeking treatment for their painful achilles tendon . a mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes . a response rate of @ % was achieved . a significant positive impact on utility was observed for chance of treatment success . a significant negative impact on utility was observed for cost , weeks before exercise can be completed free of pain , chance of side effects ( p = @ ) , and injections as a stand-alone treatment . respondents were willing to pay australian dollars ( $ a ) @ ( @ % ci -@ , @ ) for a @ % increase in the chance of treatment success . study participants with achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less , has a greater chance of success , has a shorter duration before being able to exercise free of pain , and has less likelihood of side effects . on average , participants preferred exercises over injections as a stand-alone treatment . further research is required to confirm the findings in patients outside of the trial setting . nevertheless , this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to achilles tendinopathy .
21,766,893
[ "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with st-segment elevation myocardial infarction ( stemi ) undergoing primary percutaneous coronary intervention ( pci ) has never been assessed in specifically designed randomized trials .", "the bavarian reperfusion alternatives evaluation ( brave ) @ study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in stemi patients with planned primary pci a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome .", "owing to slow recruitment , the trial was stopped prematurely after enrolment of @ of @ planned patients .", "at @ days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in @ patients ( @ % ) randomized to prasugrel plus bivalirudin and @ patients ( @ % ) randomized to clopidogrel plus heparin [ relative risk , @ ; one-sided @ % confidence interval ( ci ) @-@ @ , p = @ ] .", "the composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) .", "bleeding according to the horizons-ami definition was observed in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) .", "results were consistent across various subgroups of patients .", "in this randomized trial of stemi patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin .", "neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin .", "however , the results must be interpreted in view of the premature termination of the trial .", "unique identifier nct@ ( www.clinicaltrials.gov ) ." ]
whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with st-segment elevation myocardial infarction ( stemi ) undergoing primary percutaneous coronary intervention ( pci ) has never been assessed in specifically designed randomized trials . the bavarian reperfusion alternatives evaluation ( brave ) @ study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in stemi patients with planned primary pci a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome . owing to slow recruitment , the trial was stopped prematurely after enrolment of @ of @ planned patients . at @ days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in @ patients ( @ % ) randomized to prasugrel plus bivalirudin and @ patients ( @ % ) randomized to clopidogrel plus heparin [ relative risk , @ ; one-sided @ % confidence interval ( ci ) @-@ @ , p = @ ] . the composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) . bleeding according to the horizons-ami definition was observed in @ patients ( @ % ) in the prasugrel plus bivalirudin group and @ patients ( @ % ) in the clopidogrel plus heparin group ( relative risk , @ ; @ % ci @-@ @ , p = @ ) . results were consistent across various subgroups of patients . in this randomized trial of stemi patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin . neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin . however , the results must be interpreted in view of the premature termination of the trial . unique identifier nct@ ( www.clinicaltrials.gov ) .
24,816,809
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the long-term recurrence rates and complication of different techniques of cervical ablation .", "a randomized trial of three techniques of conization ( cold knife , laser , and loop electrosurgical excisional procedure ( leep ) ) for cervical intraepithelial neoplasia ( cin ) in which @ patients had been recruited .", "eighty-six patients were followed-up for more than @ years .", "of these @ had been treated with the cold knife , @ with leep and @ by laser .", "five recurrences were observed , one in the cold knife group , two in the leep group and two in the laser group ( p = ns ) .", "the only observed complication was cervical stenosis : zero cases in the laser group , one case in the leep group and four cases in the cold knife group ( laser versus cold knife : p = @ ; leep versus cold knife : p = @ ) .", "fifty pregnancies were observed in @ patients .", "first and second trimester outcomes of pregnancy were without complications .", "one patient treated with the leep presented with a premature rupture of membranes and premature labor at @ weeks .", "a total of nine cesarean sections were performed with two cases for cervical dystocia .", "there is no major difference in obstetrical outcome between the three techniques ." ]
to evaluate the long-term recurrence rates and complication of different techniques of cervical ablation . a randomized trial of three techniques of conization ( cold knife , laser , and loop electrosurgical excisional procedure ( leep ) ) for cervical intraepithelial neoplasia ( cin ) in which @ patients had been recruited . eighty-six patients were followed-up for more than @ years . of these @ had been treated with the cold knife , @ with leep and @ by laser . five recurrences were observed , one in the cold knife group , two in the leep group and two in the laser group ( p = ns ) . the only observed complication was cervical stenosis : zero cases in the laser group , one case in the leep group and four cases in the cold knife group ( laser versus cold knife : p = @ ; leep versus cold knife : p = @ ) . fifty pregnancies were observed in @ patients . first and second trimester outcomes of pregnancy were without complications . one patient treated with the leep presented with a premature rupture of membranes and premature labor at @ weeks . a total of nine cesarean sections were performed with two cases for cervical dystocia . there is no major difference in obstetrical outcome between the three techniques .
12,551,795
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine whether macronutrient composition of a hypocaloric diet can enhance its effectiveness and whether insulin sensitivity ( si ) affects the response to hypocaloric diets .", "obese nondiabetic insulin-sensitive ( fasting insulin < @ microu/ml ; n = @ ) and obese nondiabetic insulin-resistant ( fasting insulin > @ microu/ml ; n = @ ) women ( @ to @ years old ) were randomized to either a high carbohydrate ( cho ) ( hc ) / low fat ( lf ) ( @ % cho , @ % fat ) or low cho ( lc ) / high fat ( hf ) ( @ % cho , @ % fat ) hypocaloric diet .", "primary outcome measures after a @-week dietary intervention were : changes in body weight ( bw ) , si , resting metabolic rate , and fasting lipids .", "insulin-sensitive women on the hc/lf diet lost @ + / - @ % ( p < @ ) of their initial bw , whereas those on the lc/hf diet lost @ + / - @ % ( p < @ ; p < @ between the groups ) .", "in contrast , among the insulin-resistant women , those on the lc/hf diet lost @ + / - @ % ( p < @ ) of their initial bw as compared with @ + / - @ % ( p < @ ) lost by those on the hc/lf diet ( p < @ between two groups ) .", "these differences could not be explained by changes in resting metabolic rate , activity , or intake .", "overall , changes in si were associated with the degree of weight loss ( r = -@ , p < @ ) .", "the state of si determines the effectiveness of macronutrient composition of hypocaloric diets in obese women .", "for maximal benefit , the macronutrient composition of a hypocaloric diet may need to be adjusted to correspond to the state of si ." ]
to determine whether macronutrient composition of a hypocaloric diet can enhance its effectiveness and whether insulin sensitivity ( si ) affects the response to hypocaloric diets . obese nondiabetic insulin-sensitive ( fasting insulin < @ microu/ml ; n = @ ) and obese nondiabetic insulin-resistant ( fasting insulin > @ microu/ml ; n = @ ) women ( @ to @ years old ) were randomized to either a high carbohydrate ( cho ) ( hc ) / low fat ( lf ) ( @ % cho , @ % fat ) or low cho ( lc ) / high fat ( hf ) ( @ % cho , @ % fat ) hypocaloric diet . primary outcome measures after a @-week dietary intervention were : changes in body weight ( bw ) , si , resting metabolic rate , and fasting lipids . insulin-sensitive women on the hc/lf diet lost @ + / - @ % ( p < @ ) of their initial bw , whereas those on the lc/hf diet lost @ + / - @ % ( p < @ ; p < @ between the groups ) . in contrast , among the insulin-resistant women , those on the lc/hf diet lost @ + / - @ % ( p < @ ) of their initial bw as compared with @ + / - @ % ( p < @ ) lost by those on the hc/lf diet ( p < @ between two groups ) . these differences could not be explained by changes in resting metabolic rate , activity , or intake . overall , changes in si were associated with the degree of weight loss ( r = -@ , p < @ ) . the state of si determines the effectiveness of macronutrient composition of hypocaloric diets in obese women . for maximal benefit , the macronutrient composition of a hypocaloric diet may need to be adjusted to correspond to the state of si .
15,897,479
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the effects of dry needling of myofascial trigger points in the neck region to metoprolol in migraine prophylaxis .", "randomized , group comparative study .", "patients , investigator and statistician were blinded as to treatment , the therapist was blinded as to results .", "outpatient pain clinic in the northern copenhagen area .", "patients were referred by general practitioners or respondents to newspaper advertisements .", "included were patients with a history of migraine with or without aura for at least @ years .", "excluded were persons with contraindications against treatment with beta blockers , chronic pain syndromes , pregnancy or previous experience with acupuncture or beta-blocking agents .", "a total of @ patients were included ; @ completed the study .", "after a @-week run-in period , patients were allocated to a @-week regimen either with acupuncture and placebo tablets or to placebo stimulation and metoprolol @ mg daily .", "both groups exhibited significant reduction in attack frequency ( p < @ ) .", "no difference was found between the groups regarding frequency ( p > @ ) or duration ( p > @ ) of attacks , whereas we found a significant difference in global rating of attacks in favour of metoprolol ( p < @ ) .", "trigger point inactivation by dry needling is a valuable supplement to the list of migraine prophylactic tools , being equipotent to metoprolol in the influence on frequency and duration ( but not severity ) of attacks , and superior in terms of negative side-effects ." ]
to compare the effects of dry needling of myofascial trigger points in the neck region to metoprolol in migraine prophylaxis . randomized , group comparative study . patients , investigator and statistician were blinded as to treatment , the therapist was blinded as to results . outpatient pain clinic in the northern copenhagen area . patients were referred by general practitioners or respondents to newspaper advertisements . included were patients with a history of migraine with or without aura for at least @ years . excluded were persons with contraindications against treatment with beta blockers , chronic pain syndromes , pregnancy or previous experience with acupuncture or beta-blocking agents . a total of @ patients were included ; @ completed the study . after a @-week run-in period , patients were allocated to a @-week regimen either with acupuncture and placebo tablets or to placebo stimulation and metoprolol @ mg daily . both groups exhibited significant reduction in attack frequency ( p < @ ) . no difference was found between the groups regarding frequency ( p > @ ) or duration ( p > @ ) of attacks , whereas we found a significant difference in global rating of attacks in favour of metoprolol ( p < @ ) . trigger point inactivation by dry needling is a valuable supplement to the list of migraine prophylactic tools , being equipotent to metoprolol in the influence on frequency and duration ( but not severity ) of attacks , and superior in terms of negative side-effects .
8,182,401
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this study aimed to evaluate the effects of monophasic estrogen-progestogen therapy on the sexuality and climacteric symptoms of postmenopausal women .", "a prospective , randomised , double-blind , crossover , placebo-controlled , single-centre study was carried out over a total of @ consecutive months in @ postmenopausal women with an intact uterus who had no contraindications to hormone therapy .", "patients received @beta-estradiol @mg in combination with norethisterone acetate @mg ( cliane ) daily for @ months or one placebo tablet daily for @ months .", "the tablets were identical in appearance .", "after @ months , the groups were crossed over and the patients were followed up for another @ months .", "the groups were homogenous with respect to age , height , bodyweight , body mass index and race .", "for the statistical analysis , the group receiving hormone therapy was referred to as group a and the placebo group was designated group b , irrespective of the placebo/hormone therapy sequence .", "in group a there were fewer hot flashes ( f = @ , p < @ ) and an improvement in sexual interest ( f = @ , p < @ ) .", "the sequence in which the medication was received resulted in a statistically significant difference with respect to dyspareunia ( f = @ , p < @ ) and satisfaction with the duration of penetration ( f = @ , p < @ ) .", "in the intrapatient analysis of variation with respect to orgasmic capability and the presence of dialogue with partner regarding the couple 's sexual life , whether the placebo was taken prior to or following hormone therapy was significant ( f = @ , p < @ and f = @ , p < @ , respectively ) .", "monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women ." ]
this study aimed to evaluate the effects of monophasic estrogen-progestogen therapy on the sexuality and climacteric symptoms of postmenopausal women . a prospective , randomised , double-blind , crossover , placebo-controlled , single-centre study was carried out over a total of @ consecutive months in @ postmenopausal women with an intact uterus who had no contraindications to hormone therapy . patients received @beta-estradiol @mg in combination with norethisterone acetate @mg ( cliane ) daily for @ months or one placebo tablet daily for @ months . the tablets were identical in appearance . after @ months , the groups were crossed over and the patients were followed up for another @ months . the groups were homogenous with respect to age , height , bodyweight , body mass index and race . for the statistical analysis , the group receiving hormone therapy was referred to as group a and the placebo group was designated group b , irrespective of the placebo/hormone therapy sequence . in group a there were fewer hot flashes ( f = @ , p < @ ) and an improvement in sexual interest ( f = @ , p < @ ) . the sequence in which the medication was received resulted in a statistically significant difference with respect to dyspareunia ( f = @ , p < @ ) and satisfaction with the duration of penetration ( f = @ , p < @ ) . in the intrapatient analysis of variation with respect to orgasmic capability and the presence of dialogue with partner regarding the couple 's sexual life , whether the placebo was taken prior to or following hormone therapy was significant ( f = @ , p < @ and f = @ , p < @ , respectively ) . monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women .
17,217,318
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the clinical effect of the chinese medicinal preparation shengling capsule on patients with oligoasthenospermia .", "a total of @ male patients with infertility induced by oligoasthenospermia were equally divided into a treatment and a control group , the former medicated with shengling capsule at the dose of @ g tid , and the latter given vit e at @ mg tid , both for a course of @ weeks .", "then we analyzed the changes in the patients ` seminal parameters and the pregnancy of their wives .", "after @ weeks of medication , both the seminal parameters of the patients and pregnancy of their wives were remarkably improved , with extremely significant differences from pre-treatment and the control ( p < @ ) .", "shengjing capsule can improve sperm motility and vitality as well as sperm count .", "with few adverse effects , it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia ." ]
to investigate the clinical effect of the chinese medicinal preparation shengling capsule on patients with oligoasthenospermia . a total of @ male patients with infertility induced by oligoasthenospermia were equally divided into a treatment and a control group , the former medicated with shengling capsule at the dose of @ g tid , and the latter given vit e at @ mg tid , both for a course of @ weeks . then we analyzed the changes in the patients ` seminal parameters and the pregnancy of their wives . after @ weeks of medication , both the seminal parameters of the patients and pregnancy of their wives were remarkably improved , with extremely significant differences from pre-treatment and the control ( p < @ ) . shengjing capsule can improve sperm motility and vitality as well as sperm count . with few adverse effects , it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia .
19,852,282
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess the usefulness of helisal in the diagnosis of helicobacter pylori infection by comparing it with elisa , jatrox and histopathologic findings .", "randomized prospective study .", "sixty-one patients , thirty-three males and twenty-eight females , @-@ years old , submitted to esophagogastroduodenoscopy .", "the sensitivity of helisal when compared to elisa test was @ % , the specificity @ % , the positive predictive value @ % , the negative predictive value @ % , and the kappa index @ .", "when compared to histopathologic test : sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ .", "when compared to jatrox , sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ .", "the sensitivity of helisal test is lower than that of other compared tests , and the negative predictive value is very low .", "the specificity and the positive predictive value are higher than the sensitivity .", "the kappa index shows a very low concordance ." ]
to assess the usefulness of helisal in the diagnosis of helicobacter pylori infection by comparing it with elisa , jatrox and histopathologic findings . randomized prospective study . sixty-one patients , thirty-three males and twenty-eight females , @-@ years old , submitted to esophagogastroduodenoscopy . the sensitivity of helisal when compared to elisa test was @ % , the specificity @ % , the positive predictive value @ % , the negative predictive value @ % , and the kappa index @ . when compared to histopathologic test : sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ . when compared to jatrox , sensitivity @ % , specificity @ % , positive predictive value @ % , negative predictive value @ % , kappa @ . the sensitivity of helisal test is lower than that of other compared tests , and the negative predictive value is very low . the specificity and the positive predictive value are higher than the sensitivity . the kappa index shows a very low concordance .
9,072,052
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the effects of simvastatin on serum lipids and insulin sensitivity in type @ diabetic patients with hypercholesterolaemia .", "a double-blind , randomized , placebo-controlled and two-period crossover study .", "after a @-month run-in , @ eligible type @ diabetic patients with hypercholesterolaemia were randomized to receive either simvastatin or placebo for @ months , exchanging their treatment thereafter for another @ months .", "blood samples were taken in month @ and at monthly intervals to measure serum lipids and indices of glycaemic control .", "an euglycaemic insulin clamp was performed in months @ , @ and @ to assess change of insulin sensitivity .", "the amount of glucose infused during @-@ min of the clamp ( m ) , and the mean values of serum insulin during @-@ min ( i ) were measured .", "the m and m/i ratio were used to represent the in vivo insulin sensitivity of the subject .", "simvastatin significantly reduced serum total cholesterol ( tc ) by @ + / -@ % and low density lipoprotein-cholesterol ( ldl-c ) by @ + / -@ % .", "it did not alter glycaemic control .", "the m-values and m/i ratios were similar in both groups in each period and no drug effect on insulin sensitivity could be identified .", "simvastatin significantly reduced the serum tc and ldl-c levels without alteration of insulin sensitivity in type @ diabetic patients with hypercholesterolaemia ." ]
to evaluate the effects of simvastatin on serum lipids and insulin sensitivity in type @ diabetic patients with hypercholesterolaemia . a double-blind , randomized , placebo-controlled and two-period crossover study . after a @-month run-in , @ eligible type @ diabetic patients with hypercholesterolaemia were randomized to receive either simvastatin or placebo for @ months , exchanging their treatment thereafter for another @ months . blood samples were taken in month @ and at monthly intervals to measure serum lipids and indices of glycaemic control . an euglycaemic insulin clamp was performed in months @ , @ and @ to assess change of insulin sensitivity . the amount of glucose infused during @-@ min of the clamp ( m ) , and the mean values of serum insulin during @-@ min ( i ) were measured . the m and m/i ratio were used to represent the in vivo insulin sensitivity of the subject . simvastatin significantly reduced serum total cholesterol ( tc ) by @ + / -@ % and low density lipoprotein-cholesterol ( ldl-c ) by @ + / -@ % . it did not alter glycaemic control . the m-values and m/i ratios were similar in both groups in each period and no drug effect on insulin sensitivity could be identified . simvastatin significantly reduced the serum tc and ldl-c levels without alteration of insulin sensitivity in type @ diabetic patients with hypercholesterolaemia .
10,510,951
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "premenopausal african american women have a @-@ times greater incidence of coronary heart disease ( chd ) than do white women .", "the plasma lipid responsiveness to dietary fat , which may be associated with chd , has not been adequately studied in premenopausal african american or white women .", "the objective of our study was to compare the effect of diet on fasting plasma lipids and lipoproteins and postprandial lipemia in premenopausal african american and white women .", "thirteen african american and @ white healthy premenopausal women were fed a low-fat , high-fiber diet and a high-fat , low-fiber diet for @ wk each in a randomized crossover design .", "fasting plasma lipid and lipoprotein concentrations and the @-h plasma triacylglycerol response to a standard fatty test meal were measured at the end of each dietary period .", "plasma total and ldl-cholesterol concentrations were higher after the high-fat , low-fiber diet in both white and african american women ( p < @ ) .", "the @-h area under the plasma triacylglycerol curve after the test meal was lower after the low-fat diet than after the high-fat diet ( p < @ ) .", "african american and white women had lower fasting plasma total and ldl-cholesterol concentrations and less postprandial lipemia after the low-fat than the high-fat diet .", "diets low in total and saturated fat and cholesterol and high in fiber may reduce the risk of chd by lowering fasting plasma total and ldl-cholesterol concentrations and by reducing the lipemic response to fatty meals ." ]
premenopausal african american women have a @-@ times greater incidence of coronary heart disease ( chd ) than do white women . the plasma lipid responsiveness to dietary fat , which may be associated with chd , has not been adequately studied in premenopausal african american or white women . the objective of our study was to compare the effect of diet on fasting plasma lipids and lipoproteins and postprandial lipemia in premenopausal african american and white women . thirteen african american and @ white healthy premenopausal women were fed a low-fat , high-fiber diet and a high-fat , low-fiber diet for @ wk each in a randomized crossover design . fasting plasma lipid and lipoprotein concentrations and the @-h plasma triacylglycerol response to a standard fatty test meal were measured at the end of each dietary period . plasma total and ldl-cholesterol concentrations were higher after the high-fat , low-fiber diet in both white and african american women ( p < @ ) . the @-h area under the plasma triacylglycerol curve after the test meal was lower after the low-fat diet than after the high-fat diet ( p < @ ) . african american and white women had lower fasting plasma total and ldl-cholesterol concentrations and less postprandial lipemia after the low-fat than the high-fat diet . diets low in total and saturated fat and cholesterol and high in fiber may reduce the risk of chd by lowering fasting plasma total and ldl-cholesterol concentrations and by reducing the lipemic response to fatty meals .
10,871,561
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "mirabegron is a @-adrenoceptor agonist used for the treatment of overactive bladder .", "mirabegron is formulated as an extended-release tablet using oral controlled-absorption system ( ocas ) technology .", "this study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron ocas in accordance with regulatory requirements to support dosing recommendations .", "in this single-dose , randomized , open-label , @-period , parallel-dose-group , crossover study , mirabegron ocas @ or @ mg was administered orally to healthy adult subjects in the fasted state or after a high - or low-fat breakfast .", "dose administrations were separated by a washout period of at least @ days .", "blood samples were drawn up to @ hours after dosing , and plasma concentrations of mirabegron were analyzed by lc/ms-ms .", "pk properties were determined using noncompartmental methods .", "primary end points for the assessment of food effects were cmax and auc@ - .", "for tolerability assessment , adverse events ( aes ) were monitored using investigators ' questionnaires and subjects ' spontaneous reports , vital sign measurements , hematology , clinical chemistry , and ecg .", "thirty-eight subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) were enrolled in the @-mg dose group and @ subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) in the @-mg dose group .", "with either fed condition or dose , the @ % cis for the fed/fasted ratios of both cmax and auc@ - of mirabegron fell below the predetermined range for bioequivalence ( @ % -@ % ) , suggesting that food had no effect on exposure to mirabegron ocas .", "with the @-mg dose , mirabegron cmax was reduced by @ % with a high-fat breakfast compared with fasted conditions ( geometric mean ratio [ gmr ] , @ % [ @ % ci , @ % -@ % ] ) and auc@ - , by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) .", "with the @-mg dose , mirabegron cmax and auc@ - were reduced by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and @ % ( @ % [ @ % -@ % ] ) , respectively , after a high-fat breakfast .", "with the @-mg dose , mirabegron cmax was decreased by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and auc@ - by @ % ( @ % [ @ % -@ % ] ) after a low-fat breakfast .", "corresponding reductions with the @-mg dose were @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for cmax and @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for auc@ - .", "the fed/fasted ratios for mirabegron cmax and auc@ - were in general independent of dose or sex .", "food delayed tmax compared with the fasted state , with similar increases with the high - and low-fat meals ( @ hours with @ mg and @-@ @ hours with @ mg ) .", "mirabegron was generally well tolerated , with no apparent difference in ae frequency between the fasted and fed states .", "mirabegron ocas tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose ( @ or @ mg ) or gender but dependent on meal composition .", "a greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast .", "based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice .", "clinicaltrials.gov identifier : nct@ ." ]
mirabegron is a @-adrenoceptor agonist used for the treatment of overactive bladder . mirabegron is formulated as an extended-release tablet using oral controlled-absorption system ( ocas ) technology . this study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron ocas in accordance with regulatory requirements to support dosing recommendations . in this single-dose , randomized , open-label , @-period , parallel-dose-group , crossover study , mirabegron ocas @ or @ mg was administered orally to healthy adult subjects in the fasted state or after a high - or low-fat breakfast . dose administrations were separated by a washout period of at least @ days . blood samples were drawn up to @ hours after dosing , and plasma concentrations of mirabegron were analyzed by lc/ms-ms . pk properties were determined using noncompartmental methods . primary end points for the assessment of food effects were cmax and auc@ - . for tolerability assessment , adverse events ( aes ) were monitored using investigators ' questionnaires and subjects ' spontaneous reports , vital sign measurements , hematology , clinical chemistry , and ecg . thirty-eight subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) were enrolled in the @-mg dose group and @ subjects ( male , @ % ; mean age , @ years ; mean weight , @ kg ; race , @ % white ) in the @-mg dose group . with either fed condition or dose , the @ % cis for the fed/fasted ratios of both cmax and auc@ - of mirabegron fell below the predetermined range for bioequivalence ( @ % -@ % ) , suggesting that food had no effect on exposure to mirabegron ocas . with the @-mg dose , mirabegron cmax was reduced by @ % with a high-fat breakfast compared with fasted conditions ( geometric mean ratio [ gmr ] , @ % [ @ % ci , @ % -@ % ] ) and auc@ - , by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) . with the @-mg dose , mirabegron cmax and auc@ - were reduced by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and @ % ( @ % [ @ % -@ % ] ) , respectively , after a high-fat breakfast . with the @-mg dose , mirabegron cmax was decreased by @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) and auc@ - by @ % ( @ % [ @ % -@ % ] ) after a low-fat breakfast . corresponding reductions with the @-mg dose were @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for cmax and @ % ( gmr , @ % [ @ % ci , @ % -@ % ] ) for auc@ - . the fed/fasted ratios for mirabegron cmax and auc@ - were in general independent of dose or sex . food delayed tmax compared with the fasted state , with similar increases with the high - and low-fat meals ( @ hours with @ mg and @-@ @ hours with @ mg ) . mirabegron was generally well tolerated , with no apparent difference in ae frequency between the fasted and fed states . mirabegron ocas tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose ( @ or @ mg ) or gender but dependent on meal composition . a greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast . based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice . clinicaltrials.gov identifier : nct@ .
23,497,763
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women .", "seventy-one nonobese postmenopausal women were assigned randomly to receive hormone replacement therapy ( conjugated estrogens , @ mg , plus medroxyprogesterone acetate , @ mg ) or placebo daily for @ year ( @ women received hormone replacement therapy , and @ women received placebo ) .", "at baseline and @ months , the women received a computed tomography scan at the l@-l@ vertebral disk space , a dual x-ray absorptiometry scan , a euglycemic hyperinsulinemic clamp to measure insulin sensitivity , and a lipid profile .", "declining insulin sensitivity was defined as the largest quartile change in insulin sensitivity in the women who received the placebo ( -@ mg/min/kg lean body mass ) .", "by univariate analysis , we found that significant predictors of worsening insulin sensitivity were the use of hormone replacement therapy , baseline insulin sensitivity , a younger age , and < @ years since menopause .", "by logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity .", "the use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women ." ]
the purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women . seventy-one nonobese postmenopausal women were assigned randomly to receive hormone replacement therapy ( conjugated estrogens , @ mg , plus medroxyprogesterone acetate , @ mg ) or placebo daily for @ year ( @ women received hormone replacement therapy , and @ women received placebo ) . at baseline and @ months , the women received a computed tomography scan at the l@-l@ vertebral disk space , a dual x-ray absorptiometry scan , a euglycemic hyperinsulinemic clamp to measure insulin sensitivity , and a lipid profile . declining insulin sensitivity was defined as the largest quartile change in insulin sensitivity in the women who received the placebo ( -@ mg/min/kg lean body mass ) . by univariate analysis , we found that significant predictors of worsening insulin sensitivity were the use of hormone replacement therapy , baseline insulin sensitivity , a younger age , and < @ years since menopause . by logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity . the use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women .
16,458,629
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility .", "the aim of the present study was the assessment of selected parameters of speech with and without resection prostheses .", "the speech sounds of @ patients suffering from maxillary and mandibular defects were recorded using a digital audio tape ( dat ) recorder with and without resection prostheses .", "evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by @ experienced speech therapists .", "additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment .", "after prosthesis supply , the number of patients with rhinophonia aperta decreased from @ to @ while the number of patients with intelligible speech increased from @ to @ .", "correct production of the sounds / s / , / sch / , and / ch / increased from @ to @ patients .", "a significant improvement of the evaluated parameters could be observed only in patients with maxillary defects .", "the linguistic self-assessment showed a higher satisfaction in patients with maxillary defects .", "in patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses ." ]
ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility . the aim of the present study was the assessment of selected parameters of speech with and without resection prostheses . the speech sounds of @ patients suffering from maxillary and mandibular defects were recorded using a digital audio tape ( dat ) recorder with and without resection prostheses . evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by @ experienced speech therapists . additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment . after prosthesis supply , the number of patients with rhinophonia aperta decreased from @ to @ while the number of patients with intelligible speech increased from @ to @ . correct production of the sounds / s / , / sch / , and / ch / increased from @ to @ patients . a significant improvement of the evaluated parameters could be observed only in patients with maxillary defects . the linguistic self-assessment showed a higher satisfaction in patients with maxillary defects . in patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses .
24,107,907
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration .", "to compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion .", "a randomised comparative trial where @ women at @-@ weeks gestation , requiring medical abortion , were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of @ microg three-hourly , up to a maximum five doses over @ h.", "the same doses were repeated for another @ h in non-responders .", "primary outcome measure was complete abortion rate at @ and @ h , and the secondary outcome measures were induction-abortion interval , failure rate , side-effects and patients ' preference to the route .", "no statistically significant differences in the complete abortion rates were observed at @ h ( @ % vs @ % , p = @ ) and at @ h ( @ % vs @ % , p = @ ) when sublingual and vaginal groups were compared .", "mean induction-abortion intervals in sublingual and vaginal groups were @ and @ h , respectively ( p = @ ) .", "other outcome measures were also more or less similar in both groups .", "differences in the incidence of side-effects were also statistically insignificant when both groups were compared .", "sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( p < @ ) .", "both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients ." ]
misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration . to compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion . a randomised comparative trial where @ women at @-@ weeks gestation , requiring medical abortion , were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of @ microg three-hourly , up to a maximum five doses over @ h. the same doses were repeated for another @ h in non-responders . primary outcome measure was complete abortion rate at @ and @ h , and the secondary outcome measures were induction-abortion interval , failure rate , side-effects and patients ' preference to the route . no statistically significant differences in the complete abortion rates were observed at @ h ( @ % vs @ % , p = @ ) and at @ h ( @ % vs @ % , p = @ ) when sublingual and vaginal groups were compared . mean induction-abortion intervals in sublingual and vaginal groups were @ and @ h , respectively ( p = @ ) . other outcome measures were also more or less similar in both groups . differences in the incidence of side-effects were also statistically insignificant when both groups were compared . sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( p < @ ) . both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients .
18,366,490
[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to test the hypothesis that a garlic supplement alters plasma lipoproteins , postprandial lipemia , low-density lipoprotein ( ldl ) size and high-density lipoprotein ( hdl ) subclass distribution differently in @ moderately hypercholesterolemic subjects classified as ldl subclass pattern a or b.", "garlic has been variably reported to reduce or not affect plasma cholesterol values .", "low-density lipoprotein pattern b is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with ldl pattern a individuals .", "a double blind , randomized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean ldl cholesterol = @ + / - @ mg/dl ) classified as ldl subclass pattern a ( predominantly large ldl , n = @ ) or b ( predominantly small ldl , n = @ ) .", "following a two-month stabilization period , subjects were randomly assigned to a placebo or @ mg three times a day of a standardized garlic tablet for three months .", "for all subjects , ldl pattern a and b subjects combined , garlic treatment for three months resulted in no significant change in total cholesterol , ldl cholesterol , hdl cholesterol , hdl subclass distribution , postprandial triglycerides , apolipoprotein b , lipoprotein ( a ) ( lp [ a ] ) , ldl peak particle diameter or ldl subclass distribution .", "there was no significant difference in response for the same parameters among subjects classified as ldl pattern a or b with the exception of significantly greater ( p = @ ) reduction in mean peak particle diameter in pattern a subjects treated with either garlic or placebo .", "there was no significant change in ldl subclass distribution .", "this investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on hdl subclasses , lp ( a ) , apolipoprotein b , postprandial triglycerides or ldl subclass distribution .", "garlic may have a greater effect on ldl particle diameter in ldl pattern a compared with pattern b subjects .", "this difference was not reflected in other plasma lipid measurements ." ]
to test the hypothesis that a garlic supplement alters plasma lipoproteins , postprandial lipemia , low-density lipoprotein ( ldl ) size and high-density lipoprotein ( hdl ) subclass distribution differently in @ moderately hypercholesterolemic subjects classified as ldl subclass pattern a or b. garlic has been variably reported to reduce or not affect plasma cholesterol values . low-density lipoprotein pattern b is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with ldl pattern a individuals . a double blind , randomized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean ldl cholesterol = @ + / - @ mg/dl ) classified as ldl subclass pattern a ( predominantly large ldl , n = @ ) or b ( predominantly small ldl , n = @ ) . following a two-month stabilization period , subjects were randomly assigned to a placebo or @ mg three times a day of a standardized garlic tablet for three months . for all subjects , ldl pattern a and b subjects combined , garlic treatment for three months resulted in no significant change in total cholesterol , ldl cholesterol , hdl cholesterol , hdl subclass distribution , postprandial triglycerides , apolipoprotein b , lipoprotein ( a ) ( lp [ a ] ) , ldl peak particle diameter or ldl subclass distribution . there was no significant difference in response for the same parameters among subjects classified as ldl pattern a or b with the exception of significantly greater ( p = @ ) reduction in mean peak particle diameter in pattern a subjects treated with either garlic or placebo . there was no significant change in ldl subclass distribution . this investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on hdl subclasses , lp ( a ) , apolipoprotein b , postprandial triglycerides or ldl subclass distribution . garlic may have a greater effect on ldl particle diameter in ldl pattern a compared with pattern b subjects . this difference was not reflected in other plasma lipid measurements .
10,676,676
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in @ % of colonoscopy activity , and the need for training is undefined .", "to assess the learning curve and skill-keeping line of ileoscopy .", "prospective randomized study .", "single gi endoscopy unit .", "adult outpatients referred for colonoscopy .", "patient randomization to ileocolonoscopy by trainees and seniors .", "ileoscopy skill was divided into the following : ileocecal valve ( icv ) intubation ( success rate , time ) and ileal exploration ( length , time ) .", "consecutive blocks of @ procedures were used to calculate the learning curve and the skill-keeping line .", "variables considered to influence icv intubation were the following : endoscopist experience , icv morphology , patient age , gender , body mass index , diverticular disease , and preceding abdominal/pelvic surgery .", "learning curve showed that competency in icv intubation ( @ % success rate ) and ileal exploration ( @ cm ) was achieved after @ procedures .", "the skill-keeping line showed that ileoscopy was easy ( @ % success rate ) , fast ( @ minute ) , and well accepted up to @ cm of the ileum .", "thin-lipped and volcanic icv are the most difficult and easiest to intubate , respectively .", "crohn 's disease and adenomas of the proximal edge of icv were diagnosed in @ % .", "training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing icv intubation to maintain and increase their skill .", "ileoscopy can be difficult when the icv is thin lipped or single bulged , and easy when it has a volcanic morphology ." ]
ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in @ % of colonoscopy activity , and the need for training is undefined . to assess the learning curve and skill-keeping line of ileoscopy . prospective randomized study . single gi endoscopy unit . adult outpatients referred for colonoscopy . patient randomization to ileocolonoscopy by trainees and seniors . ileoscopy skill was divided into the following : ileocecal valve ( icv ) intubation ( success rate , time ) and ileal exploration ( length , time ) . consecutive blocks of @ procedures were used to calculate the learning curve and the skill-keeping line . variables considered to influence icv intubation were the following : endoscopist experience , icv morphology , patient age , gender , body mass index , diverticular disease , and preceding abdominal/pelvic surgery . learning curve showed that competency in icv intubation ( @ % success rate ) and ileal exploration ( @ cm ) was achieved after @ procedures . the skill-keeping line showed that ileoscopy was easy ( @ % success rate ) , fast ( @ minute ) , and well accepted up to @ cm of the ileum . thin-lipped and volcanic icv are the most difficult and easiest to intubate , respectively . crohn 's disease and adenomas of the proximal edge of icv were diagnosed in @ % . training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing icv intubation to maintain and increase their skill . ileoscopy can be difficult when the icv is thin lipped or single bulged , and easy when it has a volcanic morphology .
16,427,930
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to estimate minimally important differences ( mids ) in scores for the modified rodnan skin score ( mrss ) and health assessment questionnaire-disability index ( haq-di ) in a clinical trial on diffuse systemic sclerosis ( ssc ) .", "@ people participated in a @-year , double-blind , randomised clinical trial comparing efficacy of low-dose and high-dose d-penicillamine in diffuse ssc .", "at @ , @ , @ and @ months , the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened , moderately worsened , slightly worsened , unchanged , slightly improved , moderately improved or markedly improved .", "patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved .", "the mid estimates for the mrss improvement ranged from @ to @ ( @-@ @ effect size ) and for the haq-di from @ to @ ( @-@ @ effect size ) .", "patients who were rated to improve more than slightly were found to improve by @-@ @ ( @-@ @ effect size ) on the mrss and @-@ @ ( @-@ @ effect size ) on the haq-di score .", "mid estimates are provided for improvement in the mrss and haq-di scores , which can help in interpreting clinical trials on patients with ssc and be used for sample size calculation for future clinical trials on diffuse ssc ." ]
to estimate minimally important differences ( mids ) in scores for the modified rodnan skin score ( mrss ) and health assessment questionnaire-disability index ( haq-di ) in a clinical trial on diffuse systemic sclerosis ( ssc ) . @ people participated in a @-year , double-blind , randomised clinical trial comparing efficacy of low-dose and high-dose d-penicillamine in diffuse ssc . at @ , @ , @ and @ months , the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened , moderately worsened , slightly worsened , unchanged , slightly improved , moderately improved or markedly improved . patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved . the mid estimates for the mrss improvement ranged from @ to @ ( @-@ @ effect size ) and for the haq-di from @ to @ ( @-@ @ effect size ) . patients who were rated to improve more than slightly were found to improve by @-@ @ ( @-@ @ effect size ) on the mrss and @-@ @ ( @-@ @ effect size ) on the haq-di score . mid estimates are provided for improvement in the mrss and haq-di scores , which can help in interpreting clinical trials on patients with ssc and be used for sample size calculation for future clinical trials on diffuse ssc .
16,540,546
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "long-term pharmacological glucocorticoid ( gc ) therapy leads to skeletal muscle atrophy and weakness .", "the objective of this study was to investigate whether short-term treatment with gh and testosterone ( t ) can increase lean mass without major impairment of glucose homoeostasis in patients on gc therapy .", "this was a prospective , open-label , randomised , crossover study .", "twelve men ( age @ years ) on chronic gc treatment participated .", "the effects of @ weeks ' treatment with gh , testosterone and the combination of both on lean body mass ( lbm ) , appendicular skeletal muscle mass ( asmm ) , extracellular water ( ecw ) , body cell mass ( bcm ) and plasma glucose concentrations were investigated .", "lbm increased significantly after gh ( @ kg ; p = @ ) and gh + testosterone ( @ kg ; p = @ ) , but not testosterone alone .", "asmm increased after all three treatment periods ; by @ kg after gh ( p = @ ) , @ kg after gh + testosterone ( p = @ ) and @ kg after testosterone ( p = @ ) .", "the increase in asmm was larger with combined treatment than either gh or testosterone alone ( p < @ ) .", "ecw increased significantly after gh + testosterone by @ l ( p = @ ) but not after gh or testosterone alone .", "bcm increased slightly after single and combined treatments , but the changes were not significant .", "fasting glucose increased significantly after gh ( @ mmol/l , p = @ ) while both fasting ( @ mmol/l , p = @ ) and post glucose-load ( @ mmol/l , p = @ ) plasma glucose concentrations increased after gh + testosterone .", "gh and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose gc treatment .", "in the doses used , combination therapy increases fasting and postprandial glucose concentration ." ]
long-term pharmacological glucocorticoid ( gc ) therapy leads to skeletal muscle atrophy and weakness . the objective of this study was to investigate whether short-term treatment with gh and testosterone ( t ) can increase lean mass without major impairment of glucose homoeostasis in patients on gc therapy . this was a prospective , open-label , randomised , crossover study . twelve men ( age @ years ) on chronic gc treatment participated . the effects of @ weeks ' treatment with gh , testosterone and the combination of both on lean body mass ( lbm ) , appendicular skeletal muscle mass ( asmm ) , extracellular water ( ecw ) , body cell mass ( bcm ) and plasma glucose concentrations were investigated . lbm increased significantly after gh ( @ kg ; p = @ ) and gh + testosterone ( @ kg ; p = @ ) , but not testosterone alone . asmm increased after all three treatment periods ; by @ kg after gh ( p = @ ) , @ kg after gh + testosterone ( p = @ ) and @ kg after testosterone ( p = @ ) . the increase in asmm was larger with combined treatment than either gh or testosterone alone ( p < @ ) . ecw increased significantly after gh + testosterone by @ l ( p = @ ) but not after gh or testosterone alone . bcm increased slightly after single and combined treatments , but the changes were not significant . fasting glucose increased significantly after gh ( @ mmol/l , p = @ ) while both fasting ( @ mmol/l , p = @ ) and post glucose-load ( @ mmol/l , p = @ ) plasma glucose concentrations increased after gh + testosterone . gh and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose gc treatment . in the doses used , combination therapy increases fasting and postprandial glucose concentration .
23,169,695
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "utilization rates ( urs ) for implantable cardioverter-defibrillators ( icds ) for primary prevention of sudden cardiac death ( ppscd ) are lacking in the community .", "the purpose of this study was to establish the icd ur in central indiana .", "a query run on @ hospitals in a health information exchange database in indianapolis identified patients between @ and @ with left ventricular ejection fraction ( ef ) @ .", "icd eligibility and utilization were determined from chart review .", "we identified @ patients with at least @ low ef study .", "two cohorts were analyzed : @ patients without and @ patients with international classification of diseases , ninth revision , clinical modification procedure code @ for icd placement .", "we manually reviewed a stratified ( by hospital ) random sample of @ patients from the no-icd procedure code cohort and found that @ ( @ % ) had no icd but had class i indications for icd .", "eight of @ ( @ % ) actually had icd implantation for ppscd .", "review of all @ patients in the icd procedure code cohort identified @ with icd implantation for ppscd .", "the icd ur ( ratio between patients with icd for ppscd and all with indication ) was @ % overall ( @ % confidence interval [ ci ] @ % -@ % ) .", "urs were @ % for males ( @ % ci @ % -@ % ) , @ % for females ( @ % ci @ % -@ % , p = @ vs males ) , @ % for whites ( @ % ci @ % -@ % ) , and @ % for blacks ( @ % ci @ % -@ % , p = @ vs whites ) .", "icd ur is @ % among patients meeting class i indications , suggesting further opportunities for improving guideline compliance .", "this study also illustrates limitations in calculating icd ur using large electronic repositories without hands-on chart review ." ]
utilization rates ( urs ) for implantable cardioverter-defibrillators ( icds ) for primary prevention of sudden cardiac death ( ppscd ) are lacking in the community . the purpose of this study was to establish the icd ur in central indiana . a query run on @ hospitals in a health information exchange database in indianapolis identified patients between @ and @ with left ventricular ejection fraction ( ef ) @ . icd eligibility and utilization were determined from chart review . we identified @ patients with at least @ low ef study . two cohorts were analyzed : @ patients without and @ patients with international classification of diseases , ninth revision , clinical modification procedure code @ for icd placement . we manually reviewed a stratified ( by hospital ) random sample of @ patients from the no-icd procedure code cohort and found that @ ( @ % ) had no icd but had class i indications for icd . eight of @ ( @ % ) actually had icd implantation for ppscd . review of all @ patients in the icd procedure code cohort identified @ with icd implantation for ppscd . the icd ur ( ratio between patients with icd for ppscd and all with indication ) was @ % overall ( @ % confidence interval [ ci ] @ % -@ % ) . urs were @ % for males ( @ % ci @ % -@ % ) , @ % for females ( @ % ci @ % -@ % , p = @ vs males ) , @ % for whites ( @ % ci @ % -@ % ) , and @ % for blacks ( @ % ci @ % -@ % , p = @ vs whites ) . icd ur is @ % among patients meeting class i indications , suggesting further opportunities for improving guideline compliance . this study also illustrates limitations in calculating icd ur using large electronic repositories without hands-on chart review .
24,566,233
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved , mild , and moderate to severe reduction of left ventricular ejection fraction ( lvef ) .", "ninety-eight patients with moderate to severe ( n = @ ) , mild ( n = @ ) , and preserved ( n = @ ) lvef were randomly assigned to exercise training plus usual care ( n = @ ) or usual care alone ( n = @ ) in a randomization ratio of @:@ .", "left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention .", "exercise tolerance and lvef increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone .", "exercise training increased the mean ratio of early to late mitral inflow velocities ( e/a ratio ) and decreased deceleration time ( dt ) of early filling in patients with mild and preserved lvef .", "in patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction ( dt < @ ms ) , exercise training decreased e/a ratio and increased dt , both of which were unchanged after usual care alone .", "in the remaining patients ( dt > @ ms ) , exercise training also improved mitral inflow patterns .", "exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of lvef but not in patients with preserved lvef .", "these results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction ." ]
the study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved , mild , and moderate to severe reduction of left ventricular ejection fraction ( lvef ) . ninety-eight patients with moderate to severe ( n = @ ) , mild ( n = @ ) , and preserved ( n = @ ) lvef were randomly assigned to exercise training plus usual care ( n = @ ) or usual care alone ( n = @ ) in a randomization ratio of @:@ . left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention . exercise tolerance and lvef increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone . exercise training increased the mean ratio of early to late mitral inflow velocities ( e/a ratio ) and decreased deceleration time ( dt ) of early filling in patients with mild and preserved lvef . in patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction ( dt < @ ms ) , exercise training decreased e/a ratio and increased dt , both of which were unchanged after usual care alone . in the remaining patients ( dt > @ ms ) , exercise training also improved mitral inflow patterns . exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of lvef but not in patients with preserved lvef . these results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction .
22,005,747
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the feasibility of implementing a sleep education program ( sep ) for improving sleep in adult family home ( afh ) residents with dementia , and the relative efficacy of sep compared with usual care control in a pilot randomized controlled trial .", "thirty-seven afh staff-caregivers and @ residents with comorbid dementia and sleep disturbances .", "sep consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans .", "treatment fidelity to the sep was assessed following the national institutes of health ( nih ) behavior change consortium model utilizing trainer observations and staff-caregiver reports .", "resident sleep was assessed by wrist actigraphy at baseline , @-month posttreatment , and @-month follow-up .", "caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected .", "each key area of treatment fidelity ( sep delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes .", "staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors .", "sep decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the @-month follow-up period compared with the control condition .", "results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with afh residents with dementia ." ]
to investigate the feasibility of implementing a sleep education program ( sep ) for improving sleep in adult family home ( afh ) residents with dementia , and the relative efficacy of sep compared with usual care control in a pilot randomized controlled trial . thirty-seven afh staff-caregivers and @ residents with comorbid dementia and sleep disturbances . sep consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans . treatment fidelity to the sep was assessed following the national institutes of health ( nih ) behavior change consortium model utilizing trainer observations and staff-caregiver reports . resident sleep was assessed by wrist actigraphy at baseline , @-month posttreatment , and @-month follow-up . caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected . each key area of treatment fidelity ( sep delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes . staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors . sep decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the @-month follow-up period compared with the control condition . results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with afh residents with dementia .
22,367,233
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type @ diabetes .", "this was an open-label , randomized , parallel , three-arm multicenter trial in patients with type @ diabetes starting insulin treatment .", "patients ( n = @ ) were randomly assigned to @-week treatment with @x daily insulin lispro , @x daily lispro mid mixture ( midmix ; @ % lispro , @ % protaminated lispro ) , or @x daily insulin glargine ; oral antihyperglycemic agents were discontinued .", "primary end point was the postprandial glucose excursion @ h after breakfast at the end of study .", "secondary outcomes included hba@c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction .", "at the end of study , glucose excursions @ h after breakfast were significantly lower with lispro and midmix than with glargine ( p < @ for each vs. glargine ) : lispro , -@ + / -@ mmol/l ; midmix , +@ + / -@ mmol/l ; glargine , +@ + / -@ mmol/l .", "fasting glucose decreases were significantly greater with glargine ( -@ + / -@ mmol/l ) than with lispro or midmix ( -@ + / -@ mmol/l ; +@ + / -@ mmol/l ) .", "nevertheless , hba@c decreased by @ % ( lispro ) and @ % ( midmix ) , vs. @ % with glargine .", "hypoglycemic episodes were rare with @-@ @ self-reported episodes per @ patient-days .", "in patients with type @ diabetes starting insulin , @x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine , in spite suboptimal fasting glucose levels , which targets fasting glucose values .", "these results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving hba@c targets ." ]
to compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type @ diabetes . this was an open-label , randomized , parallel , three-arm multicenter trial in patients with type @ diabetes starting insulin treatment . patients ( n = @ ) were randomly assigned to @-week treatment with @x daily insulin lispro , @x daily lispro mid mixture ( midmix ; @ % lispro , @ % protaminated lispro ) , or @x daily insulin glargine ; oral antihyperglycemic agents were discontinued . primary end point was the postprandial glucose excursion @ h after breakfast at the end of study . secondary outcomes included hba@c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction . at the end of study , glucose excursions @ h after breakfast were significantly lower with lispro and midmix than with glargine ( p < @ for each vs. glargine ) : lispro , -@ + / -@ mmol/l ; midmix , +@ + / -@ mmol/l ; glargine , +@ + / -@ mmol/l . fasting glucose decreases were significantly greater with glargine ( -@ + / -@ mmol/l ) than with lispro or midmix ( -@ + / -@ mmol/l ; +@ + / -@ mmol/l ) . nevertheless , hba@c decreased by @ % ( lispro ) and @ % ( midmix ) , vs. @ % with glargine . hypoglycemic episodes were rare with @-@ @ self-reported episodes per @ patient-days . in patients with type @ diabetes starting insulin , @x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine , in spite suboptimal fasting glucose levels , which targets fasting glucose values . these results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving hba@c targets .
16,632,233
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "female sex workers who inject drugs ( fsw-idus ) are at risk of acquiring hiv , sexually transmitted infections ( sti ) and blood-borne infections through unprotected sex and sharing injection equipment .", "we conducted a @ factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among fsw-idus in tijuana and ciudad juarez , mexico .", "fsw-idus @ years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule , blinding interviewer/counselors to assignment .", "due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information .", "all women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role .", "each condition was a single @-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention .", "women underwent interviewer-administered surveys and testing for hiv , syphilis , gonorrhea , chlamydia , and trichomonas at baseline and quarterly for @ months .", "combined hiv/sti incidence will be the primary outcome .", "secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients .", "of @,@ women , @ ( @ % ) were excluded ( @ % were ineligible ; @ % refused to participate or did not return ) ; @ eligible women enrolled ( @ in tijuana ; @ in ciudad juarez ) .", "all @ participants completed the baseline interview , provided biological samples and were randomized to one of the four groups .", "during follow-up , @ participants ( @ % ) were lost to follow-up , of whom @ ( @ % ) had died , leaving @ participants for analysis .", "this study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among fsw-idus .", "the factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks , which will have direct , tangible policy implications for mexico and potentially other resource-poor countries .", "nct@ ." ]
female sex workers who inject drugs ( fsw-idus ) are at risk of acquiring hiv , sexually transmitted infections ( sti ) and blood-borne infections through unprotected sex and sharing injection equipment . we conducted a @ factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among fsw-idus in tijuana and ciudad juarez , mexico . fsw-idus @ years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule , blinding interviewer/counselors to assignment . due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information . all women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role . each condition was a single @-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention . women underwent interviewer-administered surveys and testing for hiv , syphilis , gonorrhea , chlamydia , and trichomonas at baseline and quarterly for @ months . combined hiv/sti incidence will be the primary outcome . secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients . of @,@ women , @ ( @ % ) were excluded ( @ % were ineligible ; @ % refused to participate or did not return ) ; @ eligible women enrolled ( @ in tijuana ; @ in ciudad juarez ) . all @ participants completed the baseline interview , provided biological samples and were randomized to one of the four groups . during follow-up , @ participants ( @ % ) were lost to follow-up , of whom @ ( @ % ) had died , leaving @ participants for analysis . this study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among fsw-idus . the factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks , which will have direct , tangible policy implications for mexico and potentially other resource-poor countries . nct@ .
22,891,807
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare oral risperidone and intramuscular ( im ) haloperidol , both in combination with im lorazepam , in the management of acute agitation and psychosis in the medical emergency department .", "in this prospective , randomized , placebo-controlled , double-blind study of @ patients presenting to the emergency department with acute agitation and/or psychosis , three groups of @ patients received oral and im medications : @ ) @ mg oral risperidone and @ mg im lorazepam ; @ ) @ mg oral haloperidol and @ mg im lorazepam ; @ ) oral placebo and @ mg im lorazepam .", "each treatment group received both an injection and a tablet to reduce treatment group variability .", "patients were evaluated using the brief psychiatric rating scale ( bprs ) and the positive and negative syndrome scale ( panss ) before receiving medication and at @ and @ minutes after medication was administered .", "the intergroup mean percent reductions in rating scale scores were compared using anova , chi-square , and kruskal-wallis tests .", "there were no statistically significant differences among the groups at any point .", "the two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone , although this trend was not statistically significant .", "lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial .", "while not statistically significant , a trend toward better outcomes with combined treatment warrants further study ." ]
to compare oral risperidone and intramuscular ( im ) haloperidol , both in combination with im lorazepam , in the management of acute agitation and psychosis in the medical emergency department . in this prospective , randomized , placebo-controlled , double-blind study of @ patients presenting to the emergency department with acute agitation and/or psychosis , three groups of @ patients received oral and im medications : @ ) @ mg oral risperidone and @ mg im lorazepam ; @ ) @ mg oral haloperidol and @ mg im lorazepam ; @ ) oral placebo and @ mg im lorazepam . each treatment group received both an injection and a tablet to reduce treatment group variability . patients were evaluated using the brief psychiatric rating scale ( bprs ) and the positive and negative syndrome scale ( panss ) before receiving medication and at @ and @ minutes after medication was administered . the intergroup mean percent reductions in rating scale scores were compared using anova , chi-square , and kruskal-wallis tests . there were no statistically significant differences among the groups at any point . the two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone , although this trend was not statistically significant . lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial . while not statistically significant , a trend toward better outcomes with combined treatment warrants further study .
16,728,906
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to prospectively evaluate the efficacy of routine ultrasound-guided fine-needle aspiration cytology ( fnac ) of thyroid nodules in an endemic area and to analyze the factors influencing it .", "patients with thyroid nodules were randomly subjected to either conventional palpation-guided fine-needle aspiration cytology ( pfnac ) or ultrasound-guided fine-needle aspiration cytology ( usfnac ) .", "the results of cytology were compared with the final histopathologic diagnosis in @ patients who had undergone surgery .", "the performance of both methods was individually analyzed in solid nodules , cystic nodules , and solitary and multinodular goitres .", "overall , usfnac showed a significantly higher sensitivity ( @ % vs @ % , p < @ ) , positive predictive value ( @ % vs @ % , p < @ ) , and greater diagnostic accuracy ( @ % vs @ % , p = @ ) compared with pfnac .", "the sensitivity of usfnac was significantly higher compared with that of pfnac in cystic and complex nodules ( @ % vs @ % , p < @ ) but not in solid nodules ( @ % vs @ % , p > @ ) .", "usfnac was more sensitive and more accurate than pfnac for detection of malignancy in multinodular goitres ( @ % vs @ % , p < @ ; @ % vs @ % , p < @ , respectively ) .", "the superiority of `` routine '' usfnac over pfnac is mainly due to its better performance in cystic nodules and multinodular goitres .", "hence , routine usfnac can be recommended in areas where such lesions constitute the majority of thyroid nodules ." ]
to prospectively evaluate the efficacy of routine ultrasound-guided fine-needle aspiration cytology ( fnac ) of thyroid nodules in an endemic area and to analyze the factors influencing it . patients with thyroid nodules were randomly subjected to either conventional palpation-guided fine-needle aspiration cytology ( pfnac ) or ultrasound-guided fine-needle aspiration cytology ( usfnac ) . the results of cytology were compared with the final histopathologic diagnosis in @ patients who had undergone surgery . the performance of both methods was individually analyzed in solid nodules , cystic nodules , and solitary and multinodular goitres . overall , usfnac showed a significantly higher sensitivity ( @ % vs @ % , p < @ ) , positive predictive value ( @ % vs @ % , p < @ ) , and greater diagnostic accuracy ( @ % vs @ % , p = @ ) compared with pfnac . the sensitivity of usfnac was significantly higher compared with that of pfnac in cystic and complex nodules ( @ % vs @ % , p < @ ) but not in solid nodules ( @ % vs @ % , p > @ ) . usfnac was more sensitive and more accurate than pfnac for detection of malignancy in multinodular goitres ( @ % vs @ % , p < @ ; @ % vs @ % , p < @ , respectively ) . the superiority of `` routine '' usfnac over pfnac is mainly due to its better performance in cystic nodules and multinodular goitres . hence , routine usfnac can be recommended in areas where such lesions constitute the majority of thyroid nodules .
19,442,372
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "dalcetrapib modulates cholesteryl ester transfer protein ( cetp ) activity to raise high-density lipoprotein cholesterol ( hdl-c ) .", "after the failure of torcetrapib it was unknown if hdl produced by interaction with cetp had pro-atherogenic or pro-inflammatory properties .", "dal-plaque is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints .", "in this phase @b , double-blind , multicentre trial , patients ( aged @-@ years ) with , or with high risk of , coronary heart disease were randomly assigned ( @:@ ) to dalcetrapib @ mg/day or placebo for @ months .", "randomisation was done with a computer-generated randomisation code and was stratified by centre .", "patients and investigators were masked to treatment .", "coprimary endpoints were mri-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after @ months and ( @ ) f-fluorodeoxyglucose ( ( @ ) f-fdg ) pet/ct assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after @ months , with no-harm boundaries established before unblinding of the trial .", "analysis was by intention to treat .", "this trial is registered at clinicaltrials.gov , nct@ .", "@ patients were screened and @ randomly assigned to placebo ( @ patients ) or dalcetrapib ( @ patients ) .", "for the coprimary mri and pet/ct endpoints , cis were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group .", "mri-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after @ months ; absolute change from baseline relative to placebo was -@ mm ( @ ) ( @ % ci -@ to -@ ; nominal p = @ ) .", "the pet/ct measure of index vessel most-diseased-segment target-to-background ratio ( tbr ) was not different between groups , but carotid artery analysis showed a @ % reduction in most-diseased-segment tbr in the dalcetrapib group compared with the placebo group ( -@ [ @ % ci -@ to -@ ] ; nominal p = @ ) .", "dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups .", "dalcetrapib showed no evidence of a pathological effect related to the arterial wall over @ months .", "moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over @ months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed .", "f hoffmann-la roche ltd. ." ]
dalcetrapib modulates cholesteryl ester transfer protein ( cetp ) activity to raise high-density lipoprotein cholesterol ( hdl-c ) . after the failure of torcetrapib it was unknown if hdl produced by interaction with cetp had pro-atherogenic or pro-inflammatory properties . dal-plaque is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints . in this phase @b , double-blind , multicentre trial , patients ( aged @-@ years ) with , or with high risk of , coronary heart disease were randomly assigned ( @:@ ) to dalcetrapib @ mg/day or placebo for @ months . randomisation was done with a computer-generated randomisation code and was stratified by centre . patients and investigators were masked to treatment . coprimary endpoints were mri-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after @ months and ( @ ) f-fluorodeoxyglucose ( ( @ ) f-fdg ) pet/ct assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after @ months , with no-harm boundaries established before unblinding of the trial . analysis was by intention to treat . this trial is registered at clinicaltrials.gov , nct@ . @ patients were screened and @ randomly assigned to placebo ( @ patients ) or dalcetrapib ( @ patients ) . for the coprimary mri and pet/ct endpoints , cis were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group . mri-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after @ months ; absolute change from baseline relative to placebo was -@ mm ( @ ) ( @ % ci -@ to -@ ; nominal p = @ ) . the pet/ct measure of index vessel most-diseased-segment target-to-background ratio ( tbr ) was not different between groups , but carotid artery analysis showed a @ % reduction in most-diseased-segment tbr in the dalcetrapib group compared with the placebo group ( -@ [ @ % ci -@ to -@ ] ; nominal p = @ ) . dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups . dalcetrapib showed no evidence of a pathological effect related to the arterial wall over @ months . moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over @ months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed . f hoffmann-la roche ltd. .
21,908,036
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data .", "the purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture .", "in four dutch hospitals , children aged @ years with a both-bone forearm fracture were prospectively followed up consecutive children for @-@ months .", "at the final follow-up , pronation/supination and angular malunion on radiographs were determined .", "between january @ and august @ , a total of @ children were prospectively followed up , of which @ children were included for analysis in this study .", "the mean age of the children was @ ( @ ) years , of which @ % were male and @ % fractured their dominant arm .", "the mean time to final examination was @ ( @ ) days .", "children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of @ had a @-@ % chance of developing a clinically relevant limitation ( i.e. , < @ of pronation and/or supination ) , while children with an angular malalignment of @ had a @ % chance .", "children with diaphyseal both-bone forearm fractures with @ of angular malalignment had a @ % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment .", "children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment ." ]
although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data . the purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture . in four dutch hospitals , children aged @ years with a both-bone forearm fracture were prospectively followed up consecutive children for @-@ months . at the final follow-up , pronation/supination and angular malunion on radiographs were determined . between january @ and august @ , a total of @ children were prospectively followed up , of which @ children were included for analysis in this study . the mean age of the children was @ ( @ ) years , of which @ % were male and @ % fractured their dominant arm . the mean time to final examination was @ ( @ ) days . children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of @ had a @-@ % chance of developing a clinically relevant limitation ( i.e. , < @ of pronation and/or supination ) , while children with an angular malalignment of @ had a @ % chance . children with diaphyseal both-bone forearm fractures with @ of angular malalignment had a @ % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment . children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment .
24,629,703
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "laparoscopic nissen fundoplication ( lnf ) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease ( gerd ) .", "postoperative paraesophageal herniation has an incidence range up to @ % in the immediate postoperative period .", "a prospective randomized trial was scheduled to study the role of posterior gastropexy , in combination with lnf , in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of gerd .", "eighty-two patients with gerd were randomized to lnf combined with ( group a , n = @ ) or without ( group b , n = @ ) posterior gastropexy .", "subjective evaluation using disease-specific and generic questionnaires and structured interviews , and objective evaluation by endoscopy , esophageal manometry , and @-h ph monitoring , were performed before operation , at @ and @ months after surgery , and then every year .", "crura approximation was performed by stitches if the diameter was less than @ cm , or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus .", "posterior gastropexy ( group a ) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament .", "sixteen patients of group a and @ patients of group b with concomitant abdominal diseases had simultaneous procedures [ cholecystectomy @ , vagotomy @ , ventral hernia repair @ , gastric polypectomy @ , gastric fundus diverticulectomy @ , gastrointestinal stromal tumor ( gist ) wedge resection @ ] .", "in mean follow-up of @ + / - @ months ( range @-@ months ) , one patient of group b presented with paraesophageal herniation in the first postoperative month ( reoperation ) , while recurrent gastroesophageal reflux ( visick iii or iv ) , successfully treated by medication , was noted in three patients of group b and in one patient of group a. only mild dysphagia , during the first two postoperative months , was noted in nine patients of group a and eight patients of group b. six patients of each group with barrett 's esophagus had endoscopic improvement after the second postoperative month .", "visick score in groups a/b was i in @/@ ( p < @ ) , ii in @/@ ( p = @ ) , iii in @/@ ( not significant , ns ) , and iv in @/@ .", "generally , visick score was i or ii in @/@ in groups a/b ( @ % / @ % , ns ) and iii or iv in @/@ ( @ % / @ % , p < @ ) .", "lnf combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of gerd , providing better early and long-term postoperative results .", "( registered clinical trial number : nct@ .", "www.clinicaltrials.gov . )" ]
laparoscopic nissen fundoplication ( lnf ) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease ( gerd ) . postoperative paraesophageal herniation has an incidence range up to @ % in the immediate postoperative period . a prospective randomized trial was scheduled to study the role of posterior gastropexy , in combination with lnf , in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of gerd . eighty-two patients with gerd were randomized to lnf combined with ( group a , n = @ ) or without ( group b , n = @ ) posterior gastropexy . subjective evaluation using disease-specific and generic questionnaires and structured interviews , and objective evaluation by endoscopy , esophageal manometry , and @-h ph monitoring , were performed before operation , at @ and @ months after surgery , and then every year . crura approximation was performed by stitches if the diameter was less than @ cm , or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus . posterior gastropexy ( group a ) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament . sixteen patients of group a and @ patients of group b with concomitant abdominal diseases had simultaneous procedures [ cholecystectomy @ , vagotomy @ , ventral hernia repair @ , gastric polypectomy @ , gastric fundus diverticulectomy @ , gastrointestinal stromal tumor ( gist ) wedge resection @ ] . in mean follow-up of @ + / - @ months ( range @-@ months ) , one patient of group b presented with paraesophageal herniation in the first postoperative month ( reoperation ) , while recurrent gastroesophageal reflux ( visick iii or iv ) , successfully treated by medication , was noted in three patients of group b and in one patient of group a. only mild dysphagia , during the first two postoperative months , was noted in nine patients of group a and eight patients of group b. six patients of each group with barrett 's esophagus had endoscopic improvement after the second postoperative month . visick score in groups a/b was i in @/@ ( p < @ ) , ii in @/@ ( p = @ ) , iii in @/@ ( not significant , ns ) , and iv in @/@ . generally , visick score was i or ii in @/@ in groups a/b ( @ % / @ % , ns ) and iii or iv in @/@ ( @ % / @ % , p < @ ) . lnf combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of gerd , providing better early and long-term postoperative results . ( registered clinical trial number : nct@ . www.clinicaltrials.gov . )
19,960,205
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "vitamin d deficiency is common in the general public and athletic populations and may impair skeletal muscle function .", "we therefore assessed the effects of vitamin d@ supplementation on serum @ [ oh ] d concentrations and physical performance .", "@ club-level athletes were block randomised ( using baseline @ [ oh ] d concentrations ) into one of three groups receiving either a placebo ( plb ) , @ @ or @ @ iu/week oral vitamin d@ for @ weeks .", "serum @ [ oh ] d and muscle function ( @-rm bench press and leg press and vertical jump height ) were measured presupplementation , @ and @ weeks postsupplementation .", "vitamin d deficiency was defined in accordance with the us institute of medicine guideline ( < @ nmol/l ) .", "@ % of the subject population were vitamin d deficient at baseline ( meansd value @ nmol/l ) .", "following @ and @ weeks supplementation with @ @ iu ( @ and @ nmol/l , respectively ) or @ @ iu vitamin d@ ( @ and @ nmol/l , respectively ) , serum vitamin d concentrations increased in all participants , with every individual achieving concentrations greater than @ nmol/l .", "in contrast , vitamin d concentration in the plb group decreased at @ and @ weeks ( @ and @ nmol/l , respectively ) .", "increasing serum @ [ oh ] d had no significant effect on any physical performance parameter ( p > @ ) .", "both @ @ and @ @ iu vitamin d@ supplementation over a @-week period elevates serum @ [ oh ] d concentrations above @ nmol/l , but neither dose given for @ weeks improved our chosen measures of physical performance ." ]
vitamin d deficiency is common in the general public and athletic populations and may impair skeletal muscle function . we therefore assessed the effects of vitamin d@ supplementation on serum @ [ oh ] d concentrations and physical performance . @ club-level athletes were block randomised ( using baseline @ [ oh ] d concentrations ) into one of three groups receiving either a placebo ( plb ) , @ @ or @ @ iu/week oral vitamin d@ for @ weeks . serum @ [ oh ] d and muscle function ( @-rm bench press and leg press and vertical jump height ) were measured presupplementation , @ and @ weeks postsupplementation . vitamin d deficiency was defined in accordance with the us institute of medicine guideline ( < @ nmol/l ) . @ % of the subject population were vitamin d deficient at baseline ( meansd value @ nmol/l ) . following @ and @ weeks supplementation with @ @ iu ( @ and @ nmol/l , respectively ) or @ @ iu vitamin d@ ( @ and @ nmol/l , respectively ) , serum vitamin d concentrations increased in all participants , with every individual achieving concentrations greater than @ nmol/l . in contrast , vitamin d concentration in the plb group decreased at @ and @ weeks ( @ and @ nmol/l , respectively ) . increasing serum @ [ oh ] d had no significant effect on any physical performance parameter ( p > @ ) . both @ @ and @ @ iu vitamin d@ supplementation over a @-week period elevates serum @ [ oh ] d concentrations above @ nmol/l , but neither dose given for @ weeks improved our chosen measures of physical performance .
23,410,885
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to probe into the clinical therapeutic effect of acupuncture on coronary heart disease complicated by type @ diabetes mellitus ( cdm ) and the mechanism .", "using multi-central , randomized , controlled and blind methods , @ cases of cdm were divided into an observation group and a control group , @ cases in each group .", "they were treated by routine therapy for diabetes mellitus , and in the observation group , acupuncture at quchi ( li @ ) , hegu ( li @ ) , xuehai ( sp @ ) , zusanli ( st @ ) , yinlingquan ( sp @ ) , fenglong ( st @ ) .", "diji ( sp @ ) , sanyinjiao ( sp @ ) , etc. were added with the needling method for regulating spleen-stomach ; while in the control group , acupuncture was given at weiwanxiashu ( ex-b @ ) , feishu ( bl @ ) , pishu ( bl @ ) , shenshu ( bl @ ) , yanglingquan ( gb @ ) , etc. .", "the treatment was given twice a day in the two groups .", "clinical therapeutic effects were assessed according to clinical symptoms and signs , frequency and lasting time of angina pectoris , quantity of taking glycerol trinitrate , blood sugar , blood lipids , urinary albumin excretion rate , urinary beta@-microglobulin , urinary monocyte chemotactic protein-@ ( mcp-@ ) , ecg , heart color doppler , etc. .", "the needling method for regulating spleen-stomach not only could improve the symptoms and signs of the patient , but also could improve the degree of st segment moving down and the function of left artrium relaxation , and had benign regulative effect on glycometabolism , lipids metabolism and urinary albumin level , with significant differences as compared with the control group ( p < @ or p < @ ) .", "the markedly effective rate for improvement of ecg was @ % in the observation group and @ % in the control group .", "the needling method for regulating spleen-stomach can improve the damage of heart and blood vessels induced by abnormal sugar and lipids , decrease the level of urinary protein , inhibit mcp-@ excessive expression , relieve myocardial load and raise cardiac output in the patient of coronary heart disease complicated by type @ diabetes mellitus ." ]
to probe into the clinical therapeutic effect of acupuncture on coronary heart disease complicated by type @ diabetes mellitus ( cdm ) and the mechanism . using multi-central , randomized , controlled and blind methods , @ cases of cdm were divided into an observation group and a control group , @ cases in each group . they were treated by routine therapy for diabetes mellitus , and in the observation group , acupuncture at quchi ( li @ ) , hegu ( li @ ) , xuehai ( sp @ ) , zusanli ( st @ ) , yinlingquan ( sp @ ) , fenglong ( st @ ) . diji ( sp @ ) , sanyinjiao ( sp @ ) , etc. were added with the needling method for regulating spleen-stomach ; while in the control group , acupuncture was given at weiwanxiashu ( ex-b @ ) , feishu ( bl @ ) , pishu ( bl @ ) , shenshu ( bl @ ) , yanglingquan ( gb @ ) , etc. . the treatment was given twice a day in the two groups . clinical therapeutic effects were assessed according to clinical symptoms and signs , frequency and lasting time of angina pectoris , quantity of taking glycerol trinitrate , blood sugar , blood lipids , urinary albumin excretion rate , urinary beta@-microglobulin , urinary monocyte chemotactic protein-@ ( mcp-@ ) , ecg , heart color doppler , etc. . the needling method for regulating spleen-stomach not only could improve the symptoms and signs of the patient , but also could improve the degree of st segment moving down and the function of left artrium relaxation , and had benign regulative effect on glycometabolism , lipids metabolism and urinary albumin level , with significant differences as compared with the control group ( p < @ or p < @ ) . the markedly effective rate for improvement of ecg was @ % in the observation group and @ % in the control group . the needling method for regulating spleen-stomach can improve the damage of heart and blood vessels induced by abnormal sugar and lipids , decrease the level of urinary protein , inhibit mcp-@ excessive expression , relieve myocardial load and raise cardiac output in the patient of coronary heart disease complicated by type @ diabetes mellitus .
18,822,974
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "use of blue dye alone as a marker for sentinel lymph node ( sln ) biopsy is effective , but combining it with isotope marking can improve the success rate .", "use of the isotope adds extra cost and there are potential radiation hazards .", "the two techniques were compared in a randomized trial .", "women with early breast cancer ( less than @ cm ) and no palpable axillary nodes were recruited .", "women older than @ years with multicentric cancers or previous surgery to the breast or axilla were excluded .", "patients were randomized to either blue dye alone or combined mapping for sln biopsy .", "all women had a level i and ii axillary dissection after the sln biopsy .", "a total of @ patients were recruited , of whom five were excluded from analysis .", "blue dye alone was used in @ women and @ had combined mapping .", "baseline demographic data were similar in the two cohorts .", "the success rate of sln biopsy was higher with combined mapping than with blue dye alone ( @ versus @ per cent ; p = @ ) .", "the accuracy and false-negative rate were similar ( accuracy @ per cent for combined mapping versus @ per cent for blue dye ; false-negative rate @ versus @ per cent ) .", "combined mapping was superior to blue dye alone in identification of the sln , but accuracy and false-negative rates were similar ." ]
use of blue dye alone as a marker for sentinel lymph node ( sln ) biopsy is effective , but combining it with isotope marking can improve the success rate . use of the isotope adds extra cost and there are potential radiation hazards . the two techniques were compared in a randomized trial . women with early breast cancer ( less than @ cm ) and no palpable axillary nodes were recruited . women older than @ years with multicentric cancers or previous surgery to the breast or axilla were excluded . patients were randomized to either blue dye alone or combined mapping for sln biopsy . all women had a level i and ii axillary dissection after the sln biopsy . a total of @ patients were recruited , of whom five were excluded from analysis . blue dye alone was used in @ women and @ had combined mapping . baseline demographic data were similar in the two cohorts . the success rate of sln biopsy was higher with combined mapping than with blue dye alone ( @ versus @ per cent ; p = @ ) . the accuracy and false-negative rate were similar ( accuracy @ per cent for combined mapping versus @ per cent for blue dye ; false-negative rate @ versus @ per cent ) . combined mapping was superior to blue dye alone in identification of the sln , but accuracy and false-negative rates were similar .
16,308,853
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "knowledge translation ( kt ) research in long-term care ( ltc ) is still in its early stages .", "this protocol describes the evaluation of a multifaceted , interdisciplinary kt intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into ltc care processes .", "the vitamin d and osteoporosis study ( vidos ) is underway in @ ltc homes ( n = @ intervention , n = @ control ) across ontario , canada .", "the primary objectives of this study are to assess the feasibility of delivering the kt intervention , and clinically , to increase the percent of ltc residents prescribed @ iu of vitamin d daily .", "eligibility criteria are ltc homes that are serviced by our partner pharmacy provider and have more than one prescribing physician .", "the target audience within each ltc home is the professional advisory committee ( pac ) , an interdisciplinary team who meets quarterly .", "the key elements of the intervention are three interactive educational sessions led by an expert opinion leader , action planning using a quality improvement cycle , audit and feedback reports , nominated internal champions , and reminders/point-of-care tools .", "control homes do not receive any intervention , however both intervention and control homes received educational materials as part of the ontario osteoporosis strategy .", "primary outcomes are feasibility measures ( recruitment , retention , attendance at educational sessions , action plan items identified and initiated , internal champions identified , performance reports provided and reviewed ) , and vitamin d ( @ iu/daily ) prescribing at @ and @ months .", "secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures .", "qualitative methods will examine the experience of the ltc team with the kt intervention .", "homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence .", "randomization is stratified by home size and profit/nonprofit status .", "prescribing data retrieval and analysis are performed by blinded personnel .", "our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to ltc practitioners .", "lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in ltc ." ]
knowledge translation ( kt ) research in long-term care ( ltc ) is still in its early stages . this protocol describes the evaluation of a multifaceted , interdisciplinary kt intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into ltc care processes . the vitamin d and osteoporosis study ( vidos ) is underway in @ ltc homes ( n = @ intervention , n = @ control ) across ontario , canada . the primary objectives of this study are to assess the feasibility of delivering the kt intervention , and clinically , to increase the percent of ltc residents prescribed @ iu of vitamin d daily . eligibility criteria are ltc homes that are serviced by our partner pharmacy provider and have more than one prescribing physician . the target audience within each ltc home is the professional advisory committee ( pac ) , an interdisciplinary team who meets quarterly . the key elements of the intervention are three interactive educational sessions led by an expert opinion leader , action planning using a quality improvement cycle , audit and feedback reports , nominated internal champions , and reminders/point-of-care tools . control homes do not receive any intervention , however both intervention and control homes received educational materials as part of the ontario osteoporosis strategy . primary outcomes are feasibility measures ( recruitment , retention , attendance at educational sessions , action plan items identified and initiated , internal champions identified , performance reports provided and reviewed ) , and vitamin d ( @ iu/daily ) prescribing at @ and @ months . secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures . qualitative methods will examine the experience of the ltc team with the kt intervention . homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence . randomization is stratified by home size and profit/nonprofit status . prescribing data retrieval and analysis are performed by blinded personnel . our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to ltc practitioners . lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in ltc .
22,624,776
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to describe the psychometric properties and identify the minimally important difference ( mid ) of the hepatitis c virus patient-reported outcomes ( hcv-pro ) instrument .", "chronic hcv infection and associated treatments negatively affect pros of function and well-being .", "in a phase @ trial , hcv-infected patients received direct-acting antivirals ( daas ) for @weeks with peg-interferon/ribavirin ( peg-ifn/rbv ) for @weeks , or placebo plus peg-ifn/rbv .", "the hcv-pro total score , sf-@ pcs and mcs scores , eq-@d-@l , and eq vas were measured at baseline , week @ , end of daa treatment ( eodt ) , end of peg-ifn/rbv treatment ( eot ) , and posttreatment week @ ( svr@ ) .", "convergent validity of the hcv-pro was assessed by pearson 's correlation coefficients .", "discriminant validity was assessed by analyzing mean hcv-pro total scores by eq-@d anxiety/depression and pain/discomfort domain scores ( none vs. some ) and presence/absence of depression or fatigue adverse events .", "mid was identified through effect size ( es ) and receiver-operating characteristic ( roc ) curve analyses ( hcv-pro response vs. sf-@ pcs/mcs and eq vas mid thresholds ) .", "in @ patients ( @ % female ; @ % white ; @ % @years ) , correlations ( @-@ @ ) between hcv-pro total scores , sf-@ pcs/mcs scores , and eq vas scores at all time points supported convergent validity .", "hcv-pro total scores were reduced to @-@ points in patients impaired by depression , pain , or fatigue symptoms .", "impact of peg-ifn/rbv regimen on hcv-pro es increased over time ( eodt -@ ; eot -@ ) .", "es and roc curve analyses indicated an mid of -@ points .", "the hcv-pro was valid and responsive in the population studied .", "an mid of -@ points represented a threshold of clinical significance for the hcv-pro ." ]
to describe the psychometric properties and identify the minimally important difference ( mid ) of the hepatitis c virus patient-reported outcomes ( hcv-pro ) instrument . chronic hcv infection and associated treatments negatively affect pros of function and well-being . in a phase @ trial , hcv-infected patients received direct-acting antivirals ( daas ) for @weeks with peg-interferon/ribavirin ( peg-ifn/rbv ) for @weeks , or placebo plus peg-ifn/rbv . the hcv-pro total score , sf-@ pcs and mcs scores , eq-@d-@l , and eq vas were measured at baseline , week @ , end of daa treatment ( eodt ) , end of peg-ifn/rbv treatment ( eot ) , and posttreatment week @ ( svr@ ) . convergent validity of the hcv-pro was assessed by pearson 's correlation coefficients . discriminant validity was assessed by analyzing mean hcv-pro total scores by eq-@d anxiety/depression and pain/discomfort domain scores ( none vs. some ) and presence/absence of depression or fatigue adverse events . mid was identified through effect size ( es ) and receiver-operating characteristic ( roc ) curve analyses ( hcv-pro response vs. sf-@ pcs/mcs and eq vas mid thresholds ) . in @ patients ( @ % female ; @ % white ; @ % @years ) , correlations ( @-@ @ ) between hcv-pro total scores , sf-@ pcs/mcs scores , and eq vas scores at all time points supported convergent validity . hcv-pro total scores were reduced to @-@ points in patients impaired by depression , pain , or fatigue symptoms . impact of peg-ifn/rbv regimen on hcv-pro es increased over time ( eodt -@ ; eot -@ ) . es and roc curve analyses indicated an mid of -@ points . the hcv-pro was valid and responsive in the population studied . an mid of -@ points represented a threshold of clinical significance for the hcv-pro .
24,036,634
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician .", "a series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life .", "we have performed a prospective , randomized , controlled trial to evaluate the effect of placement of an artificial bowel sphincter ( acticon neosphincter ) on continence and quality of life in a group of severely incontinent adults .", "fourteen adults ( male : female , @:@ ; age range , @-@ years ) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study .", "the principal outcome measure was the level of continence , measured with the cleveland continence score , which provides a scale from @ to @ , representing perfect control through to total incontinence .", "secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group , and the changes in quality of life in both groups .", "in the control group , the cleveland continence score was not significantly altered , with an initial value of @ + / - @ and a final value of @ + / - @ at six months .", "the artificial bowel sphincter group showed a highly significant improvement , changing from @ + / - @ before placement to @ + / - @ at six months after placement .", "one patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device ( @ percent explantation rate ) .", "there were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another .", "there were major improvements in the quality of life for all measures in the artificial bowel sphincter group .", "there was significant improvement in all eight subscales of the medical outcome study short form-@ measures .", "the american medical systems quality of life score was raised from @ + / - @ to @ + / - @ and the beck depression inventory showed reduction from a level of mild depression ( @ + / - @ ) to a normal value ( @ + / - @ ) .", "no significant changes in any of the quality of life measures occurred for the control group .", "through a prospective , randomized trial format , we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone .", "perioperative and late problems are likely to continue to occur and between @ percent and @ percent of patients may require permanent explantation .", "for the remainder , the device is easy and discrete to use , highly effective in achieving continence , and able to generate a major improvement in the quality of life ." ]
severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician . a series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life . we have performed a prospective , randomized , controlled trial to evaluate the effect of placement of an artificial bowel sphincter ( acticon neosphincter ) on continence and quality of life in a group of severely incontinent adults . fourteen adults ( male : female , @:@ ; age range , @-@ years ) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study . the principal outcome measure was the level of continence , measured with the cleveland continence score , which provides a scale from @ to @ , representing perfect control through to total incontinence . secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group , and the changes in quality of life in both groups . in the control group , the cleveland continence score was not significantly altered , with an initial value of @ + / - @ and a final value of @ + / - @ at six months . the artificial bowel sphincter group showed a highly significant improvement , changing from @ + / - @ before placement to @ + / - @ at six months after placement . one patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device ( @ percent explantation rate ) . there were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another . there were major improvements in the quality of life for all measures in the artificial bowel sphincter group . there was significant improvement in all eight subscales of the medical outcome study short form-@ measures . the american medical systems quality of life score was raised from @ + / - @ to @ + / - @ and the beck depression inventory showed reduction from a level of mild depression ( @ + / - @ ) to a normal value ( @ + / - @ ) . no significant changes in any of the quality of life measures occurred for the control group . through a prospective , randomized trial format , we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone . perioperative and late problems are likely to continue to occur and between @ percent and @ percent of patients may require permanent explantation . for the remainder , the device is easy and discrete to use , highly effective in achieving continence , and able to generate a major improvement in the quality of life .
15,622,577
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "statins are known to reduce plasma c-reactive protein ( crp ) concentrations .", "our goal was to define the mechanisms by which crp was reduced by maximal dose atorvastatin .", "eight subjects with combined hyperlipidemia ( @ men and @ postmenopausal women ) were enrolled in a randomized , placebo-controlled double-blind , cross over study .", "subjects underwent a @-h primed-constant infusion with deuterated leucine after @ weeks of placebo and @mg/day of atorvastatin .", "crp was isolated from lipoprotein deficient plasma , ( density > @ g/ml ) by affinity chromatography .", "isotopic enrichment was determined by gas chromatography/mass spectrometry .", "kinetic parameters were determined using compartmental modeling .", "paired t test and wilcoxon signed ranks test were used to compare differences between placebo and atorvastatin .", "compared with placebo , atorvastatin decreased median crp pool size by @ % ( @ vs @ mg ; p = @ ) , associated with a median crp fractional catabolic rate increase of @ % ( @ vs @ pools/day ; p = @ ) , with no significant effect on median crp production rate ( @ vs @ mg/kg/day ; p = @ ) .", "our data indicate that maximal doses of atorvastatin lower plasma crp levels by substantially decreasing the median crp plasma residence time from @ days to @ days , with no significant effect on the median crp production rate ." ]
statins are known to reduce plasma c-reactive protein ( crp ) concentrations . our goal was to define the mechanisms by which crp was reduced by maximal dose atorvastatin . eight subjects with combined hyperlipidemia ( @ men and @ postmenopausal women ) were enrolled in a randomized , placebo-controlled double-blind , cross over study . subjects underwent a @-h primed-constant infusion with deuterated leucine after @ weeks of placebo and @mg/day of atorvastatin . crp was isolated from lipoprotein deficient plasma , ( density > @ g/ml ) by affinity chromatography . isotopic enrichment was determined by gas chromatography/mass spectrometry . kinetic parameters were determined using compartmental modeling . paired t test and wilcoxon signed ranks test were used to compare differences between placebo and atorvastatin . compared with placebo , atorvastatin decreased median crp pool size by @ % ( @ vs @ mg ; p = @ ) , associated with a median crp fractional catabolic rate increase of @ % ( @ vs @ pools/day ; p = @ ) , with no significant effect on median crp production rate ( @ vs @ mg/kg/day ; p = @ ) . our data indicate that maximal doses of atorvastatin lower plasma crp levels by substantially decreasing the median crp plasma residence time from @ days to @ days , with no significant effect on the median crp production rate .
23,218,801
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , high-carbohydrate diet in @ niddm subjects .", "a crossover design with diet interventions and wash-out periods of @ wk was applied .", "the patients were randomly assigned to a @-wk treatment with a high-carbohydrate diet containing @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) or an isocaloric diet with @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) .", "on the last day of the two diets , @-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates .", "the diet rich in monounsaturated fat reduced daytime systolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and @-h systolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as well as daytime diastolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and diurnal diastolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as compared with the high-carbohydrate diet .", "evidence of lowered blood glucose levels on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( @ + / - @ vs. @ + / - @ mm , p < @ ) , lower average blood glucose levels ( @ + / - @ vs. @ + / - @ mm , p < @ ) , and peak blood glucose responses ( @ + / - @ vs. @ + / - @ mm , p < @ ) .", "the two diets had the same impact on lipid levels .", "a diet rich in monounsaturated fat has beneficial effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in niddm subjects is detected ." ]
to compare the influence on blood pressure , glucose , and lipid levels of a diet rich in monounsaturated fatty acids with an isocaloric , high-carbohydrate diet in @ niddm subjects . a crossover design with diet interventions and wash-out periods of @ wk was applied . the patients were randomly assigned to a @-wk treatment with a high-carbohydrate diet containing @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) or an isocaloric diet with @ % of energy as carbohydrate and @ % of energy as fat ( @ % of energy as monounsaturated fatty acids ) . on the last day of the two diets , @-h ambulatory blood pressure was measured and day profiles of glucose , hormones , and lipids were performed to a test menu rich in carbohydrates . the diet rich in monounsaturated fat reduced daytime systolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and @-h systolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as well as daytime diastolic ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) and diurnal diastolic blood pressure ( @ + / - @ vs. @ + / - @ mmhg , p < @ ) as compared with the high-carbohydrate diet . evidence of lowered blood glucose levels on the high-monounsaturated diet compared with the high-carbohydrate diet were found with lower fasting blood glucose ( @ + / - @ vs. @ + / - @ mm , p < @ ) , lower average blood glucose levels ( @ + / - @ vs. @ + / - @ mm , p < @ ) , and peak blood glucose responses ( @ + / - @ vs. @ + / - @ mm , p < @ ) . the two diets had the same impact on lipid levels . a diet rich in monounsaturated fat has beneficial effects on blood pressure and glucose metabolism , whereas no adverse effects on lipid composition in niddm subjects is detected .
8,117,360
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the injection of stem cells in the context of acute myocardial infarction ( ami ) has been tested almost exclusively by anterograde intra-arterial coronary ( iac ) delivery .", "the retrograde intravenous coronary ( ivc ) delivery may be an additional route .", "to compare the cell distribution and retention pattern in the anterograde and retrograde routes .", "to investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells ( bmmc ) in ami .", "this was a prospective , open label , randomized study .", "patients with ami who presented : ( @ ) successful chemical or mechanical reperfusion within @ hours of symptom onset and ( @ ) infarction involving more than @ % of the left ventricle ( lv ) at the myocardial scintigraphy were included in the study .", "one hundred million bmmc were injected into the infarction-related artery through iac route , or vein through the ivc route .", "one percent of the injected cells were labeled with @mtc-hexamethyl-propylene-amine-oxime ( @mtc-hmpao ) .", "cell distribution was evaluated at @ and @ hours after the myocardial scintigraphy injection .", "cardiac magnetic resonance imaging was performed before cell injection .", "thirty patients were randomized into three groups .", "there were no serious adverse events related to the procedure .", "the early and late retention of labeled cells was higher in the iac group than in ivc group , regardless of the presence of microcirculation obstruction .", "the injection using the retrograde approach was feasible and safe .", "cell retention by cardiac tissue was higher using the anterograde approach .", "more studies are needed to confirm these findings ." ]
the injection of stem cells in the context of acute myocardial infarction ( ami ) has been tested almost exclusively by anterograde intra-arterial coronary ( iac ) delivery . the retrograde intravenous coronary ( ivc ) delivery may be an additional route . to compare the cell distribution and retention pattern in the anterograde and retrograde routes . to investigate the role of microvascular obstruction by magnetic resonance imaging in cell retention by cardiac tissue after the injection of bone marrow mononuclear cells ( bmmc ) in ami . this was a prospective , open label , randomized study . patients with ami who presented : ( @ ) successful chemical or mechanical reperfusion within @ hours of symptom onset and ( @ ) infarction involving more than @ % of the left ventricle ( lv ) at the myocardial scintigraphy were included in the study . one hundred million bmmc were injected into the infarction-related artery through iac route , or vein through the ivc route . one percent of the injected cells were labeled with @mtc-hexamethyl-propylene-amine-oxime ( @mtc-hmpao ) . cell distribution was evaluated at @ and @ hours after the myocardial scintigraphy injection . cardiac magnetic resonance imaging was performed before cell injection . thirty patients were randomized into three groups . there were no serious adverse events related to the procedure . the early and late retention of labeled cells was higher in the iac group than in ivc group , regardless of the presence of microcirculation obstruction . the injection using the retrograde approach was feasible and safe . cell retention by cardiac tissue was higher using the anterograde approach . more studies are needed to confirm these findings .
22,193,396
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "maximal consumption of oxygen ( vo ( @ ) max ) during exercise is used in patients with chronic obstructive pulmonary disease ( copd ) to stratify perioperative risk .", "however , the impact of therapeutic hyperoxia ( i.e. , use of supplemental oxygen to prevent hypoxemia during exercise ) on ( vo ( @ ) max and other ventilatory parameters during maximal exercise in the resting normoxic copd population is poorly defined .", "a randomized , double-blind crossover study was performed in which resting normoxic subjects ( n = @ ) with copd underwent two standard symptom-limited , ramped-protocol bicycle ergometry cardiopulmonary exercise tests > @ days apart with fio ( @ ) of @ ( control ) and ~ @ ( therapeutic hyperoxia ) .", "vo ( @ ) max and other ventilatory parameters were compared using a paired two-sample t-test .", "therapeutic hyperoxia significantly increased vo ( @ ) max ( @ @ vs. @ @ ml/kg/min , p = @ ) , partial pressure of end-tidal carbon dioxide , and oxygen saturation and significantly decreased ve-vco ( @ ) slope , but it did not affect exercise time , maximum watts achieved , maximum minute ventilation , or change in end-expiratory lung volume .", "three of four subjects with vo ( @ ) max < @ ml/kg/min without supplemental oxygen increased vo ( @ ) max to @ ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category .", "therapeutic hyperoxia in a resting normoxic copd population significantly improves vo ( @ ) max and may change perioperative risk stratification by conventional criteria .", "further studies are needed to determine if this change in stratification is appropriate ." ]
maximal consumption of oxygen ( vo ( @ ) max ) during exercise is used in patients with chronic obstructive pulmonary disease ( copd ) to stratify perioperative risk . however , the impact of therapeutic hyperoxia ( i.e. , use of supplemental oxygen to prevent hypoxemia during exercise ) on ( vo ( @ ) max and other ventilatory parameters during maximal exercise in the resting normoxic copd population is poorly defined . a randomized , double-blind crossover study was performed in which resting normoxic subjects ( n = @ ) with copd underwent two standard symptom-limited , ramped-protocol bicycle ergometry cardiopulmonary exercise tests > @ days apart with fio ( @ ) of @ ( control ) and ~ @ ( therapeutic hyperoxia ) . vo ( @ ) max and other ventilatory parameters were compared using a paired two-sample t-test . therapeutic hyperoxia significantly increased vo ( @ ) max ( @ @ vs. @ @ ml/kg/min , p = @ ) , partial pressure of end-tidal carbon dioxide , and oxygen saturation and significantly decreased ve-vco ( @ ) slope , but it did not affect exercise time , maximum watts achieved , maximum minute ventilation , or change in end-expiratory lung volume . three of four subjects with vo ( @ ) max < @ ml/kg/min without supplemental oxygen increased vo ( @ ) max to @ ml/kg/min on therapeutic hyperoxia and potentially changed perioperative risk category . therapeutic hyperoxia in a resting normoxic copd population significantly improves vo ( @ ) max and may change perioperative risk stratification by conventional criteria . further studies are needed to determine if this change in stratification is appropriate .
22,249,909
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "survivors of advanced hodgkin disease , who were assigned randomly to treatment by mechlorethamine , vincristine , procarbazine , and prednisone ( mopp ) ; doxorubicin , bleomycin , vinblastine , and dacarbazine ( abvd ) ; or mopp alternating with abvd in a clinical trial of the cancer and leukemia group b ( protocol @ ) , were compared in terms of their psychosocial adaptation and psychosexual function an average of @ years after completion of treatment ( range , @-@ years ) .", "the study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens .", "ninety-three disease-free survivors of advanced hodgkin disease ( @ men and @ women ) were studied ( a minimum of @ year after completion of treatment ) by an interview conducted over the telephone .", "standardized measures were used to assess their psychologic , sexual , family , and vocational functioning , including the following tests : the psychosocial adjustment to illness scale -- self report , the brief symptom inventory , the profile of mood states , and the impact of event scale .", "contrary to expectation , no statistically significant differences in survivors ' psychosocial adaptation or psychosexual function were found by treatment arm .", "infertility ( based on survivors ' reports of medical test results and perceptions ) and lower income @ year before the diagnosis of cancer were significant predictors of poorer adjustment .", "most survivors reported a range of problems that they attributed to having had cancer : @ % , proven or perceived infertility ; @ % , sexual problems ; @ % , health and life insurance problems ; @ % , a negative socioeconomic effect ; and @ % , conditioned nausea , associated with visual or olfactory reminders of chemotherapy .", "no significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of hodgkin disease treated by the less gonadally toxic abvd regimen @ to @ years after completion of treatment ." ]
survivors of advanced hodgkin disease , who were assigned randomly to treatment by mechlorethamine , vincristine , procarbazine , and prednisone ( mopp ) ; doxorubicin , bleomycin , vinblastine , and dacarbazine ( abvd ) ; or mopp alternating with abvd in a clinical trial of the cancer and leukemia group b ( protocol @ ) , were compared in terms of their psychosocial adaptation and psychosexual function an average of @ years after completion of treatment ( range , @-@ years ) . the study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens . ninety-three disease-free survivors of advanced hodgkin disease ( @ men and @ women ) were studied ( a minimum of @ year after completion of treatment ) by an interview conducted over the telephone . standardized measures were used to assess their psychologic , sexual , family , and vocational functioning , including the following tests : the psychosocial adjustment to illness scale -- self report , the brief symptom inventory , the profile of mood states , and the impact of event scale . contrary to expectation , no statistically significant differences in survivors ' psychosocial adaptation or psychosexual function were found by treatment arm . infertility ( based on survivors ' reports of medical test results and perceptions ) and lower income @ year before the diagnosis of cancer were significant predictors of poorer adjustment . most survivors reported a range of problems that they attributed to having had cancer : @ % , proven or perceived infertility ; @ % , sexual problems ; @ % , health and life insurance problems ; @ % , a negative socioeconomic effect ; and @ % , conditioned nausea , associated with visual or olfactory reminders of chemotherapy . no significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of hodgkin disease treated by the less gonadally toxic abvd regimen @ to @ years after completion of treatment .
1,384,949
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "calcitonin gene-related peptide is a pleiotropic neuropeptide with potent vasodilatory properties , which interferes with renin release and might participate in cardiovascular homeostasis .", "we studied the influence of salt intake on the plasma concentration of calcitonin gene-related peptide , parathyroid hormone and on the renin-aldosterone system in @ patients with mild hypertension .", "each participant was studied after @ week of high salt intake ( @ mmol/day ) and after @ week of low salt intake ( @ mmol/day ) .", "the order of the two diet periods was randomized and crossover .", "plasma calcitonin gene-related peptide concentration was measured by radioimmunoassay after pre-extraction by reverse chromatography .", "seven patients were classified as salt-sensitive and eight as salt-resistant .", "in the whole group the low salt intake caused a significant decrease in arterial pressure and the expected increase in plasma renin activity and in plasma aldosterone concentration .", "such changes were accompanied by a significant increase in plasma calcitonin gene-related peptide .", "in salt-resistant patients in the sodium-replete state calcitonin gene-related peptide levels tended to be reduced in comparison with salt-sensitive patients .", "sodium depletion , however , caused a more pronounced rise in plasma calcitonin gene-related peptide in salt-resistant hypertensives , who attained levels close to those in salt-sensitive hypertensives .", "interestingly , in salt-resistant hypertensives changes in plasma calcitonin gene-related peptide were closely related to plasma renin activity ( r = @ , p = @ ) , whereas no such correlation was found in salt-sensitive patients .", "parathyroid hormone was not influenced by changes in salt intake .", "in subjects with mild hypertension calcitonin gene-related peptide is sensitive to changes in salt intake in the physiological range .", "such a response seems to be linked to the individual arterial pressure response to salt , because salt-resistant patients showed reduced calcitonin gene-related peptide levels in the sodium-replete state and a more pronounced calcitonin gene-related peptide increase , closely related to plasma renin activity , during sodium deprivation ." ]
calcitonin gene-related peptide is a pleiotropic neuropeptide with potent vasodilatory properties , which interferes with renin release and might participate in cardiovascular homeostasis . we studied the influence of salt intake on the plasma concentration of calcitonin gene-related peptide , parathyroid hormone and on the renin-aldosterone system in @ patients with mild hypertension . each participant was studied after @ week of high salt intake ( @ mmol/day ) and after @ week of low salt intake ( @ mmol/day ) . the order of the two diet periods was randomized and crossover . plasma calcitonin gene-related peptide concentration was measured by radioimmunoassay after pre-extraction by reverse chromatography . seven patients were classified as salt-sensitive and eight as salt-resistant . in the whole group the low salt intake caused a significant decrease in arterial pressure and the expected increase in plasma renin activity and in plasma aldosterone concentration . such changes were accompanied by a significant increase in plasma calcitonin gene-related peptide . in salt-resistant patients in the sodium-replete state calcitonin gene-related peptide levels tended to be reduced in comparison with salt-sensitive patients . sodium depletion , however , caused a more pronounced rise in plasma calcitonin gene-related peptide in salt-resistant hypertensives , who attained levels close to those in salt-sensitive hypertensives . interestingly , in salt-resistant hypertensives changes in plasma calcitonin gene-related peptide were closely related to plasma renin activity ( r = @ , p = @ ) , whereas no such correlation was found in salt-sensitive patients . parathyroid hormone was not influenced by changes in salt intake . in subjects with mild hypertension calcitonin gene-related peptide is sensitive to changes in salt intake in the physiological range . such a response seems to be linked to the individual arterial pressure response to salt , because salt-resistant patients showed reduced calcitonin gene-related peptide levels in the sodium-replete state and a more pronounced calcitonin gene-related peptide increase , closely related to plasma renin activity , during sodium deprivation .
7,868,872
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