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pubmed-text-classification-cased

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RESULTS	Validation tests indicate that the 2-point LSS model developed for the reference formulation predicts accurately ( R2 > 0.90 ) : ( a ) the individual AUC0-72 for the test formulation in the same group of volunteers ; ( b ) the individual AUC0-72 for the same reference formulation in another bioequivalence study in Brazilian volunteers ; ( c ) the average AUC0-72 reported in seven additional international studies performed under protocols similar to the present investigation ; ( d ) the individual AUC0-72 corresponding to concentration data points provided by a first-order compartmental pharmacokinetic model , when the relative values of either the absorption rate ( Kabs ) or the bioavailability ( F ) model parameters were set at 0.85 or 0.6 , of their respective original values .	Validation tests indicate that the 2-point LSS model developed for the reference formulation predicts accurately (R2 > 0. 90) : (a) the individual AUC0-72 for the test formulation in the same group of volunteers ; (b) the individual AUC0-72 for the same reference formulation in another bioequivalence study in Brazilian volunteers ; (c) the average AUC0-72 reported in seven additional international studies performed under protocols similar to the present investigation ; (d) the individual AUC0-72 corresponding to concentration data points provided by a first-order compartmental pharmacokinetic model, when the relative values of either the absorption rate (Kabs) or the bioavailability (F) model parameters were set at 0. 85 or 0. 6, of their respective original values.
CONCLUSIONS	The 2-point LSS models developed in the current study predict accurately the AUC of amlodipine under a variety of experimental conditions and , thus , may be valuable for exploring the relationships between the pharmacokinetics and pharmacodynamics of this calcium antagonist , at reduced costs of sample acquisition and analysis , and avoiding sampling at `` unsociable '' hours .	The 2-point LSS models developed in the current study predict accurately the AUC of amlodipine under a variety of experimental conditions and, thus, may be valuable for exploring the relationships between the pharmacokinetics and pharmacodynamics of this calcium antagonist, at reduced costs of sample acquisition and analysis, and avoiding sampling at '' unsociable '' hours.
BACKGROUND	Few strategies are available for the prevention of cognitive impairment in elderly persons .	Few strategies are available for the prevention of cognitive impairment in elderly persons.
BACKGROUND	Serum lipoprotein levels may be important predictors of cognitive function , and drugs that lower cholesterol may be effective for the prevention of cognitive impairment .	Serum lipoprotein levels may be important predictors of cognitive function, and drugs that lower cholesterol may be effective for the prevention of cognitive impairment.
OBJECTIVE	To determine whether serum lipoprotein levels , the 4-year change in serum lipoprotein levels , and the use of statin drugs are associated with cognition in older women without dementia .	To determine whether serum lipoprotein levels, the 4-year change in serum lipoprotein levels, and the use of statin drugs are associated with cognition in older women without dementia.
METHODS	An observational study of 1037 postmenopausal women with coronary heart disease enrolled in the Heart and Estrogen/progestin Replacement Study ( participants at 10 of 20 centers ) .	An observational study of 1037 postmenopausal women with coronary heart disease enrolled in the Heart and Estrogen/progestin Replacement Study (participants at 10 of 20 centers).
METHODS	The Modified Mini-Mental State Examination was administered at the end of the study after 4 years of follow-up .	The Modified Mini-Mental State Examination was administered at the end of the study after 4 years of follow-up.
METHODS	Women whose score was less than 84 points ( > 1.5 SDs below the mean ) were classified as having cognitive impairment .	Women whose score was less than 84 points (> 1. 5 SDs below the mean) were classified as having cognitive impairment.
METHODS	Lipoprotein levels ( total , high-density lipoprotein , and low-density lipoprotein [ LDL ] cholesterol and triglycerides ) were measured at baseline and at the end of the study ; statin use was documented at each visit .	Lipoprotein levels (total, high-density lipoprotein, and low-density lipoprotein [LDL] cholesterol and triglycerides) were measured at baseline and at the end of the study ; statin use was documented at each visit.
RESULTS	Compared with women in the lower quartiles , women in the highest LDL cholesterol quartile at cognitive testing had worse mean plus minus SD Modified Mini-Mental State Examination scores ( 93.7 plus minus 6.0 vs 91.9 plus minus 7.6 ; P = .002 ) and an increased likelihood of cognitive impairment ( adjusted odds ratio , 1.76 ; 95 % confidence interval , 1.04-2 .97 ) .	Compared with women in the lower quartiles, women in the highest LDL cholesterol quartile at cognitive testing had worse mean plus minus SD Modified Mini-Mental State Examination scores (93. 7 plus minus 6. 0 vs 91. 9 plus minus 7. 6 ; P =. 002) and an increased likelihood of cognitive impairment (adjusted odds ratio, 1. 76 ; 95 % confidence interval, 1. 04-2. 97).
RESULTS	A reduction in the LDL cholesterol level during the 4 years tended to be associated with a lower odds of impairment ( adjusted odds ratio , 0.61 ; 95 % confidence interval , 0.36-1 .03 ) compared with women whose levels increased .	A reduction in the LDL cholesterol level during the 4 years tended to be associated with a lower odds of impairment (adjusted odds ratio, 0. 61 ; 95 % confidence interval, 0. 36-1. 03) compared with women whose levels increased.
RESULTS	Higher total and LDL cholesterol levels , corrected for lipoprotein ( a ) levels , were also associated with a worse Modified Mini-Mental State Examination score and a higher likelihood of impairment , whereas high-density lipoprotein cholesterol and triglyceride levels were not associated with cognition .	Higher total and LDL cholesterol levels, corrected for lipoprotein (a) levels, were also associated with a worse Modified Mini-Mental State Examination score and a higher likelihood of impairment, whereas high-density lipoprotein cholesterol and triglyceride levels were not associated with cognition.
RESULTS	Compared with nonusers , statin users had higher mean plus minus SD Modified Mini-Mental State Examination scores ( 92.7 plus minus 7.1 vs 93.7 plus minus 6.1 ; P = .02 ) and a trend for a lower likelihood of cognitive impairment ( odds ratio , 0.67 ; 95 % confidence interval , 0.42-1 .05 ) , findings that seemed to be independent of lipid levels .	Compared with nonusers, statin users had higher mean plus minus SD Modified Mini-Mental State Examination scores (92. 7 plus minus 7. 1 vs 93. 7 plus minus 6. 1 ; P =. 02) and a trend for a lower likelihood of cognitive impairment (odds ratio, 0. 67 ; 95 % confidence interval, 0. 42-1. 05), findings that seemed to be independent of lipid levels.
CONCLUSIONS	High LDL and total cholesterol levels are associated with cognitive impairment , and lowering these lipoprotein levels may be a strategy for preventing impairment .	High LDL and total cholesterol levels are associated with cognitive impairment, and lowering these lipoprotein levels may be a strategy for preventing impairment.
CONCLUSIONS	The association between statin use and better cognitive function in women without dementia requires further study .	The association between statin use and better cognitive function in women without dementia requires further study.
OBJECTIVE	Analysing and presenting data on different outcomes after sick-leave is challenging .	Analysing and presenting data on different outcomes after sick-leave is challenging.
OBJECTIVE	The use of extended statistical methods supplies additional information and allows further exploitation of data .	The use of extended statistical methods supplies additional information and allows further exploitation of data.
METHODS	Four hundred and fifty-seven patients , sick-listed for 8-12 weeks for low back pain , were randomized to intervention ( n = 237 ) or control ( n = 220 ) .	Four hundred and fifty-seven patients, sick-listed for 8-12 weeks for low back pain, were randomized to intervention (n = 237) or control (n = 220).
METHODS	Outcome was measured as : `` sick-listed '' , `` returned to work '' , or `` disability pension '' .	Outcome was measured as : '' sick-listed '', '' returned to work '', or '' disability pension ''.
METHODS	The individuals shifted between the three states between one and 22 times ( mean 6.4 times ) .	The individuals shifted between the three states between one and 22 times (mean 6. 4 times).
METHODS	In a multi-state model , shifting between the states was set up in a transition intensity matrix .	In a multi-state model, shifting between the states was set up in a transition intensity matrix.
METHODS	The probability of being in any of the states was calculated as a transition probability matrix .	The probability of being in any of the states was calculated as a transition probability matrix.
METHODS	The effects of the intervention were modelled using a non-parametric model .	The effects of the intervention were modelled using a non-parametric model.
RESULTS	There was an effect of the intervention for leaving the state sick-listed and shifting to returned to work ( relative risk ( RR ) = 1.27 , 95 % confidence interval ( CI ) 1.09 - 1.47 ) .	There was an effect of the intervention for leaving the state sick-listed and shifting to returned to work (relative risk (RR) = 1. 27, 95 % confidence interval (CI) 1. 09 - 1. 47).
RESULTS	The nonparametric estimates showed an effect of the intervention for leaving sick-listed and shifting to returned to work in the first 6 months .	The nonparametric estimates showed an effect of the intervention for leaving sick-listed and shifting to returned to work in the first 6 months.
RESULTS	We found a protective effect of the intervention for shifting back to sick-listed between 6 and 18 months .	We found a protective effect of the intervention for shifting back to sick-listed between 6 and 18 months.
RESULTS	The analyses showed that the probability of staying in the state returned to work was not different between the intervention and control groups at the end of the follow-up ( 3 years ) .	The analyses showed that the probability of staying in the state returned to work was not different between the intervention and control groups at the end of the follow-up (3 years).
CONCLUSIONS	We demonstrate that these alternative analyses give additional results and increase the strength of the analyses .	We demonstrate that these alternative analyses give additional results and increase the strength of the analyses.
CONCLUSIONS	The simple intervention did not decrease the probability of being on sick-leave in the long term ; however , it decreased the time that individuals were on sick-leave .	The simple intervention did not decrease the probability of being on sick-leave in the long term ; however, it decreased the time that individuals were on sick-leave.
OBJECTIVE	The purpose of this study was to compare the cost of percutaneous coronary intervention ( PCI ) using bivalirudin with provisional platelet glycoprotein ( GP ) IIb/IIIa inhibition with that of heparin + routine GP IIb/IIIa inhibition .	The purpose of this study was to compare the cost of percutaneous coronary intervention (PCI) using bivalirudin with provisional platelet glycoprotein (GP) IIb/IIIa inhibition with that of heparin + routine GP IIb/IIIa inhibition.
BACKGROUND	Although GP IIb/IIIa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoing PCI , many patients currently do not receive such therapy because of concerns about bleeding complications or cost .	Although GP IIb/IIIa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoing PCI, many patients currently do not receive such therapy because of concerns about bleeding complications or cost.
BACKGROUND	Recently , bivalirudin with provisional GP IIb/IIIa inhibition has been validated as an alternative to heparin + routine GP IIb/IIIa inhibition for patients undergoing PCI .	Recently, bivalirudin with provisional GP IIb/IIIa inhibition has been validated as an alternative to heparin + routine GP IIb/IIIa inhibition for patients undergoing PCI.
BACKGROUND	However , the cost-effectiveness of this novel strategy is unknown .	However, the cost-effectiveness of this novel strategy is unknown.
METHODS	In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events ( REPLACE ) -2 trial , 4,651 U.S. patients undergoing non-emergent PCI were randomized to receive bivalirudin with provisional GP IIb/IIIa ( n = 2,319 ) versus heparin + routine GP IIb/IIIa ( n = 2,332 ) .	In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE) -2 trial, 4, 651 U. S. patients undergoing non-emergent PCI were randomized to receive bivalirudin with provisional GP IIb/IIIa (n = 2, 319) versus heparin + routine GP IIb/IIIa (n = 2, 332).
METHODS	Resource utilization data were collected prospectively through 30-day follow-up on all U.S. patients .	Resource utilization data were collected prospectively through 30-day follow-up on all U. S. patients.
METHODS	Medical care costs were estimated using standard methods including bottom-up accounting ( for procedural costs ) , the Medicare fee schedule ( for physician services ) , hospital billing data ( for 2,821 of 4,862 admissions ) , and regression-based approaches for the remaining hospitalizations .	Medical care costs were estimated using standard methods including bottom-up accounting (for procedural costs), the Medicare fee schedule (for physician services), hospital billing data (for 2, 821 of 4, 862 admissions), and regression-based approaches for the remaining hospitalizations.
RESULTS	Among the bivalirudin group , 7.7 % required provisional GP IIb/IIIa .	Among the bivalirudin group, 7. 7 % required provisional GP IIb/IIIa.
RESULTS	Thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and GP IIb/IIIa groups , but bivalirudin resulted in lower rates of major bleeding ( 2.8 % vs. 4.5 % , p = 0.002 ) and minor bleeding ( 15.1 % vs. 28.1 % , p < 0.001 ) .	Thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and GP IIb/IIIa groups, but bivalirudin resulted in lower rates of major bleeding (2. 8 % vs. 4. 5 %, p = 0. 002) and minor bleeding (15. 1 % vs. 28. 1 %, p < 0. 001).
RESULTS	Compared with routine GP IIb/IIIa , in-hospital and 30-day costs were reduced by $ 405 ( 95 % confidence interval [ CI ] $ 37 to $ 773 ) and $ 374 ( 95 % CI $ 61 to $ 688 ) per patient with bivalirudin ( p < 0.001 for both ) .	Compared with routine GP IIb/IIIa, in-hospital and 30-day costs were reduced by $ 405 (95 % confidence interval [CI] $ 37 to $ 773) and $ 374 (95 % CI $ 61 to $ 688) per patient with bivalirudin (p < 0. 001 for both).
RESULTS	Regression modeling demonstrated that , in addition to the costs of the anticoagulants themselves , hospital savings were due primarily to reductions in major bleeding ( cost savings = $ 107/patient ) , minor bleeding ( $ 52/patient ) , and thrombocytopenia ( $ 47/patient ) .	Regression modeling demonstrated that, in addition to the costs of the anticoagulants themselves, hospital savings were due primarily to reductions in major bleeding (cost savings = $ 107/patient), minor bleeding ($ 52/patient), and thrombocytopenia ($ 47/patient).