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METHODS
Adverse events were recorded .
Adverse events were recorded.
RESULTS
rhPTH ( 1-34 ) increased lumbar BMD significantly more than did elcatonin at 3 months and 6 months ( 2.38 % vs 0.59 % , P < 0.05 ; 5.51 % vs 1.55 % , P < 0.01 ) , but there were no significant increases of BMD in these two groups at femoral neck .
rhPTH (1-34) increased lumbar BMD significantly more than did elcatonin at 3 months and 6 months (2. 38 % vs 0. 59 %, P < 0. 05 ; 5. 51 % vs 1. 55 %, P < 0. 01), but there were no significant increases of BMD in these two groups at femoral neck.
RESULTS
There were larger mean increases in bone markers in the rhPTH ( 1-34 ) group than in the elcatonin group at 3 months and 6 months ( serum bone-specific alkaline phosphatase ( BSAP ) 36.79 % vs 0.31 % ; 92.42 % vs -0.17 % ; urinary N-telopeptide/creatinine ( NTX/Cr ) 48.91 % vs -5.32 % ; 68.82 % vs -10.86 % ) .
There were larger mean increases in bone markers in the rhPTH (1-34) group than in the elcatonin group at 3 months and 6 months (serum bone-specific alkaline phosphatase (BSAP) 36. 79 % vs 0. 31 % ; 92. 42 % vs -0. 17 % ; urinary N-telopeptide/creatinine (NTX/Cr) 48. 91 % vs -5. 32 % ; 68. 82 % vs -10. 86 %).
RESULTS
Both treatments were well tolerated and there were no significant differences detected between the two groups in the proportion of any adverse events and any serious adverse events ( 67.0 % vs 59.0 % ; 0 vs 0 ) .
Both treatments were well tolerated and there were no significant differences detected between the two groups in the proportion of any adverse events and any serious adverse events (67. 0 % vs 59. 0 % ; 0 vs 0).
CONCLUSIONS
rhPTH ( 1-34 ) has more positive effects on bone formation , as shown by the larger increments of lumbar BMD and bone formation markers , than elcatonin , with only mild adverse events and no significant change in the liver , kidney or hematological indices .
rhPTH (1-34) has more positive effects on bone formation, as shown by the larger increments of lumbar BMD and bone formation markers, than elcatonin, with only mild adverse events and no significant change in the liver, kidney or hematological indices.
BACKGROUND
Information regarding prognostic factors and survival in elderly women with metastatic breast cancer treated with tamoxifen is limited .
Information regarding prognostic factors and survival in elderly women with metastatic breast cancer treated with tamoxifen is limited.
METHODS
The data from 4 prospective clinical trials were analyzed , including information on 396 postmenopausal women with advanced breast cancer who received tamoxifen as initial therapy for metastatic disease .
The data from 4 prospective clinical trials were analyzed, including information on 396 postmenopausal women with advanced breast cancer who received tamoxifen as initial therapy for metastatic disease.
METHODS
Emphasis was placed on 184 elderly patients ( age greater than 65 years ) to characterize the response to therapy , time to progression TTP ) , overall survival ( OS ) , prognostic factors , and treatment-related toxicity .
Emphasis was placed on 184 elderly patients (age greater than 65 years) to characterize the response to therapy, time to progression TTP), overall survival (OS), prognostic factors, and treatment-related toxicity.
RESULTS
Among 363 patients with measurable or evaluable disease , the objective response rates were higher in the elderly patients ( 46 % versus 33 % , P = 0.06 ) ; but age did not achieve significance in a logistic regression analysis ( P = 0.1 ) .
Among 363 patients with measurable or evaluable disease, the objective response rates were higher in the elderly patients (46 % versus 33 %, P = 0. 06) ; but age did not achieve significance in a logistic regression analysis (P = 0. 1).
RESULTS
The median TTP ( 10.5 months versus 6.2 months , log rank P = 0.002 ) and OS ( 35.7 months versus 28.8 months , log rank P = 0.02 ) were superior in the elderly cohort .
The median TTP (10. 5 months versus 6. 2 months, log rank P = 0. 002) and OS (35. 7 months versus 28. 8 months, log rank P = 0. 02) were superior in the elderly cohort.
RESULTS
In multivariate analysis , age at diagnosis approached statistical significance ( P = 0.055 ) for TTP but was not significant for OS ( P = 0.17 ) .
In multivariate analysis, age at diagnosis approached statistical significance (P = 0. 055) for TTP but was not significant for OS (P = 0. 17).
RESULTS
Among elderly patients , disease free interval ( DFI ) ( greater than 5 years ) , dominant disease site ( soft tissue ) , prior adjuvant chemotherapy , positive estrogen/progesterone receptor ( ER/PgR ) and performance status ( PS ) were independent prognostic factors .
Among elderly patients, disease free interval (DFI) (greater than 5 years), dominant disease site (soft tissue), prior adjuvant chemotherapy, positive estrogen/progesterone receptor (ER/PgR) and performance status (PS) were independent prognostic factors.
RESULTS
Hot flashes were common in both younger and older cohorts ( 25 % versus 33 % , P = 0.14 ) , while anorexia ( 14 % versus 22 % , P = 0.04 ) and mood changes ( 2 % versus 6 % , P = 0.03 ) were more common in the elderly patients .
Hot flashes were common in both younger and older cohorts (25 % versus 33 %, P = 0. 14), while anorexia (14 % versus 22 %, P = 0. 04) and mood changes (2 % versus 6 %, P = 0. 03) were more common in the elderly patients.
CONCLUSIONS
There was no indication that elderly women with metastatic breast cancer treated with tamoxifen have a poorer outcome with regard to response rate , TTP or OS ; in fact , they appeared to have a slightly better prognosis although this was not significant after adjustment for other prognostic factors .
There was no indication that elderly women with metastatic breast cancer treated with tamoxifen have a poorer outcome with regard to response rate, TTP or OS ; in fact, they appeared to have a slightly better prognosis although this was not significant after adjustment for other prognostic factors.
CONCLUSIONS
In elderly patients , DFI , PS , positive ER or PGR , and dominant disease site are independent prognostic factors .
In elderly patients, DFI, PS, positive ER or PGR, and dominant disease site are independent prognostic factors.
OBJECTIVE
To evaluate unattended full polysomnography ( PSG ) recorded in the home by the DigiTrace Home Sleep System ( DHSS ) and to assess the ability to acquire , store and analyze polysomnographic data using the DHSS compared to standard paper PSG .
To evaluate unattended full polysomnography (PSG) recorded in the home by the DigiTrace Home Sleep System (DHSS) and to assess the ability to acquire, store and analyze polysomnographic data using the DHSS compared to standard paper PSG.
METHODS
Part 1 used a prospective , cross-over design .
Part 1 used a prospective, cross-over design.
METHODS
Part 2 consisted of a prospective concurrent collection of polysomnographic data .
Part 2 consisted of a prospective concurrent collection of polysomnographic data.
METHODS
Sleep Disorders Center in a university medical center .
Sleep Disorders Center in a university medical center.
METHODS
All adult patients who required standard clinical PSG as part of their clinical evaluation , regardless of suspected diagnosis , except patients requiring video recording for abnormal behaviors .
All adult patients who required standard clinical PSG as part of their clinical evaluation, regardless of suspected diagnosis, except patients requiring video recording for abnormal behaviors.
RESULTS
The DHSS is a digital recording system with miniature preamplifiers and the capacity to record 18 channels of polysomnographic data , including 4 channels of EEG ( C3-A2 , C4-A1 , C3-O1 and C4-O2 ) , right and left EOG , two channels of chin EMG , ECG naso-oral airflow , respiratory effort ( piezo crystal thoracic and abdominal belts and bilateral interacostal EMG ) , snore microphone , bilateral anterior tibialis EMG , and body-position sensor .
The DHSS is a digital recording system with miniature preamplifiers and the capacity to record 18 channels of polysomnographic data, including 4 channels of EEG (C3-A2, C4-A1, C3-O1 and C4-O2), right and left EOG, two channels of chin EMG, ECG naso-oral airflow, respiratory effort (piezo crystal thoracic and abdominal belts and bilateral interacostal EMG), snore microphone, bilateral anterior tibialis EMG, and body-position sensor.
RESULTS
In part 1,77 DHSS home recordings were evaluated .
In part 1, 77 DHSS home recordings were evaluated.
RESULTS
No recordings were lost due to equipment failure and each parameter was scorable in greater than 95 % of all epochs .
No recordings were lost due to equipment failure and each parameter was scorable in greater than 95 % of all epochs.
RESULTS
Most of the subjective assessments by questionnaire following each study revealed no difference between the two testing situations .
Most of the subjective assessments by questionnaire following each study revealed no difference between the two testing situations.
RESULTS
However , patients reported more sleep time and a better overall test experience in the lab .
However, patients reported more sleep time and a better overall test experience in the lab.
RESULTS
Assessments of sleep quality and morning alertness compared to usual were rated higher in the lab .
Assessments of sleep quality and morning alertness compared to usual were rated higher in the lab.
RESULTS
After completing both studies , more patients preferred the lab study ( p < .01 ) , mostly because of minor inconveniences and apprehension regarding acquisition of data during the home study .
After completing both studies, more patients preferred the lab study (p <. 01), mostly because of minor inconveniences and apprehension regarding acquisition of data during the home study.
RESULTS
There was no difference in the assessment of which test most accurately represented their sleep .
There was no difference in the assessment of which test most accurately represented their sleep.
RESULTS
In Part 2 , the DHSS recorded concurrently with paper PSG in the laboratory in 16 patients .
In Part 2, the DHSS recorded concurrently with paper PSG in the laboratory in 16 patients.
RESULTS
The results show no significant differences for any parameter and strong positive correlations for all parameters .
The results show no significant differences for any parameter and strong positive correlations for all parameters.
CONCLUSIONS
Using the DHSS , unattended full PSG can be performed in the home with reliable and high quality recordings .
Using the DHSS, unattended full PSG can be performed in the home with reliable and high quality recordings.
CONCLUSIONS
Full PSG can be extended to a larger patient population , because it is no longer limited by the number of beds , and there is a reduction in cost due to elimination of overnight staff and facility cost .
Full PSG can be extended to a larger patient population, because it is no longer limited by the number of beds, and there is a reduction in cost due to elimination of overnight staff and facility cost.
BACKGROUND
PPIs are widely used in peptic diseases , and this paper is to investigate the kinetic characteristics of a new PPI ilaprazole in Chinese healthy subjects and the association with CYP3A5 and CYP2C19 polymorphisms .
PPIs are widely used in peptic diseases, and this paper is to investigate the kinetic characteristics of a new PPI ilaprazole in Chinese healthy subjects and the association with CYP3A5 and CYP2C19 polymorphisms.
METHODS
21 subjects were selected and treated with 10mg ilaprazole according to their CYP3A5 * 3 genotypes ( including 7 of CYP3A5 * 1 / * 1 , 7 of * 1 / * 3 , and 7 of * 3 / * 3 ) .
21 subjects were selected and treated with 10mg ilaprazole according to their CYP3A5 * 3 genotypes (including 7 of CYP3A5 * 1 / * 1, 7 of * 1 / * 3, and 7 of * 3 / * 3).
METHODS
The plasma concentrations of ilaprazole and its metabolites were monitored by LC-MS/MS method .
The plasma concentrations of ilaprazole and its metabolites were monitored by LC-MS/MS method.
RESULTS
The C ( max ) , AUC ( ( 0-6 ) ) , AUC ( ( 0-48 ) ) and AUC ( ( 0-infinity ) ) of ilaprazole were all significantly different across the 3 CYP3A5 genotypes ( including 4 of CYP3A5 * 1 / * 1 , 4 of * 1 / * 3 , 3 of * 3 / * 3 ; P < 0.05 ) in CYP2C19 wild-type subjects ( CYP2C19 wt/wts ) , similar variety of C ( max ) and AUC ( ( 0-6 ) ) among CYP3A5 genotypes ( including 3 of CYP3A5 * 1 / * 1 , 3 of * 1 / * 3 , 4 of * 3 / * 3 ; P < 0.05 ) were also observed in CYP2C19 heterozygous subjects ( CYP2C19 wt/mts ) .
The C (max), AUC ((0-6)), AUC ((0-48)) and AUC ((0-infinity)) of ilaprazole were all significantly different across the 3 CYP3A5 genotypes (including 4 of CYP3A5 * 1 / * 1, 4 of * 1 / * 3, 3 of * 3 / * 3 ; P < 0. 05) in CYP2C19 wild-type subjects (CYP2C19 wt/wts), similar variety of C (max) and AUC ((0-6)) among CYP3A5 genotypes (including 3 of CYP3A5 * 1 / * 1, 3 of * 1 / * 3, 4 of * 3 / * 3 ; P < 0. 05) were also observed in CYP2C19 heterozygous subjects (CYP2C19 wt/mts).
RESULTS
The sulfoxidation metabolic index ( measure of collective CYP3A activity ) indicates that the CYP3A5 * 1 / * 1 , ( high-expressers ) , * 1 / * 3 , ( low-expressers ) , and * 3 / * 3 ( no-expressers ) groups have medium , lowest and highest activities on ilaprazole metabolism , inconsistent with genotype-based CYP3A5 enzymatic activity .
The sulfoxidation metabolic index (measure of collective CYP3A activity) indicates that the CYP3A5 * 1 / * 1, (high-expressers), * 1 / * 3, (low-expressers), and * 3 / * 3 (no-expressers) groups have medium, lowest and highest activities on ilaprazole metabolism, inconsistent with genotype-based CYP3A5 enzymatic activity.
RESULTS
Further analysis showed no correlation between ilaprazole metabolism and CYP2C19 genotypes , evidenced by that the AUC ( ( 0-infinity ) ) of ilaprazole from either CYP3A5 * 1 / * 1 or CYP3A5 * 1 / * 3 groups was much higher in CYP2C19 wt/wts ( n = 4 ) than that in CYP2C19 wt/mts ( n = 3 ) ( P < 0.001 ) , but the C ( max ) and AUC ( ( 0-6 ) ) of ilaprazole from CYP3A5 * 3 / * 3 groups , were significantly lower in CYP2C19 wt/wts ( n = 3 ) compared to CYP2C19 wt/mts ( n = 4 ) ( P < 0.01 ) .
Further analysis showed no correlation between ilaprazole metabolism and CYP2C19 genotypes, evidenced by that the AUC ((0-infinity)) of ilaprazole from either CYP3A5 * 1 / * 1 or CYP3A5 * 1 / * 3 groups was much higher in CYP2C19 wt/wts (n = 4) than that in CYP2C19 wt/mts (n = 3) (P < 0. 001), but the C (max) and AUC ((0-6)) of ilaprazole from CYP3A5 * 3 / * 3 groups, were significantly lower in CYP2C19 wt/wts (n = 3) compared to CYP2C19 wt/mts (n = 4) (P < 0. 01).
CONCLUSIONS
There was no demonstrated relationship between ilaprazole metabolism and CYP3A5 polymorphisms .
There was no demonstrated relationship between ilaprazole metabolism and CYP3A5 polymorphisms.
OBJECTIVE
Gd-DTPA is a well-characterized , safe contrast agent frequently used in magnetic resonance imaging ( MRI ) of the central nervous system .
Gd-DTPA is a well-characterized, safe contrast agent frequently used in magnetic resonance imaging (MRI) of the central nervous system.
OBJECTIVE
The purpose of this double-blind , comparative MRI study of brain , spine , trunk , and limbs was to evaluate the safety and efficacy of Gd-DOTA versus Gd-DTPA in a large number of patients ( n = 1038 ) .
The purpose of this double-blind, comparative MRI study of brain, spine, trunk, and limbs was to evaluate the safety and efficacy of Gd-DOTA versus Gd-DTPA in a large number of patients (n = 1038).
METHODS
T1-weighted MRI was performed before contrast and after the administration of Gd-DOTA or Gd-DTPA ( 0.1 mmol/kg ) .
T1-weighted MRI was performed before contrast and after the administration of Gd-DOTA or Gd-DTPA (0. 1 mmol/kg).
METHODS
The MR images were scored for image quality , and the diagnostic efficacy also was assessed .
The MR images were scored for image quality, and the diagnostic efficacy also was assessed.
METHODS
Patients were questioned 1 hour after injection , and adverse reactions were recorded .
Patients were questioned 1 hour after injection, and adverse reactions were recorded.
RESULTS
Image quality of the T1-weighted MR images without contrast was good or excellent in 89.7 % and 91.7 % of the Gd-DOTA and Gd-DTPA groups , respectively ( P > 0.2 ) .
Image quality of the T1-weighted MR images without contrast was good or excellent in 89. 7 % and 91. 7 % of the Gd-DOTA and Gd-DTPA groups, respectively (P > 0. 2).
RESULTS
After contrast , 85.8 % ( Gd-DOTA ) and 88.2 % ( Gd-DTPA ) of the T1-weighted MR images were of good to excellent image quality ( P > 0.2 ) , significantly less than before contrast ( P < 0.001 , both groups ) .
After contrast, 85. 8 % (Gd-DOTA) and 88. 2 % (Gd-DTPA) of the T1-weighted MR images were of good to excellent image quality (P > 0. 2), significantly less than before contrast (P < 0. 001, both groups).
RESULTS
In 82.3 % of the Gd-DOTA group and 83.5 % of the Gd-DTPA group ( P > 0.2 ) , the information obtained was more accurate with the administration of contrast agents .
In 82. 3 % of the Gd-DOTA group and 83. 5 % of the Gd-DTPA group (P > 0. 2), the information obtained was more accurate with the administration of contrast agents.
RESULTS
In 82.4 % ( Gd-DTPA ) and 81.9 % ( Gd-DOTA ) of patients , confirmation was obtained of diagnosis without contrast , whereas in 17.0 % and 17.3 % of patients , therapy was modified as a result of the use of contrast ( P > 0.2 , both groups ) .
In 82. 4 % (Gd-DTPA) and 81. 9 % (Gd-DOTA) of patients, confirmation was obtained of diagnosis without contrast, whereas in 17. 0 % and 17. 3 % of patients, therapy was modified as a result of the use of contrast (P > 0. 2, both groups).
RESULTS
The MRI investigation was reported as abnormal in 58.3 % ( Gd-DOTA ) and 59.6 % of patients ( Gd-DTPA ) , indicating a similar prevalence of disease in each group .
The MRI investigation was reported as abnormal in 58. 3 % (Gd-DOTA) and 59. 6 % of patients (Gd-DTPA), indicating a similar prevalence of disease in each group.
RESULTS
Patients responded that 97.8 % ( Gd-DOTA ) and 98.5 % ( Gd-DTPA ) of the investigations went well and adverse reactions , none of them serious , were encountered in 0.97 % of Gd-DOTA and 0.77 % of Gd-DTPA groups ( P > 0.2 , both groups ) .
Patients responded that 97. 8 % (Gd-DOTA) and 98. 5 % (Gd-DTPA) of the investigations went well and adverse reactions, none of them serious, were encountered in 0. 97 % of Gd-DOTA and 0. 77 % of Gd-DTPA groups (P > 0. 2, both groups).
CONCLUSIONS
This double-blind , randomized , clinical trial comparing Gd-DTPA and Gd-DOTA revealed no serious adverse reactions , whereas minor adverse reactions were encountered in fewer than 1 % of patients .
This double-blind, randomized, clinical trial comparing Gd-DTPA and Gd-DOTA revealed no serious adverse reactions, whereas minor adverse reactions were encountered in fewer than 1 % of patients.
CONCLUSIONS
Gd-DOTA is as safe a contrast agent as Gd-DTPA and has similar diagnostic efficacy .
Gd-DOTA is as safe a contrast agent as Gd-DTPA and has similar diagnostic efficacy.
OBJECTIVE
This study included 54-month-old children with a history of institutional care .
This study included 54-month-old children with a history of institutional care.
OBJECTIVE
Our goal was to : ( 1 ) examine differences in indiscriminate social behaviors in children with a history of institutional care compared with home-reared children ; ( 2 ) test whether foster care reduces indiscriminate social behaviors in a randomized controlled trial ; and ( 3 ) examine early predictors of indiscriminate behaviors .
Our goal was to : (1) examine differences in indiscriminate social behaviors in children with a history of institutional care compared with home-reared children ; (2) test whether foster care reduces indiscriminate social behaviors in a randomized controlled trial ; and (3) examine early predictors of indiscriminate behaviors.
METHODS
Participants were 58 children with a history of institutional care and 31 never-institutionalized control ( NIG ) subjects enrolled in a randomized controlled trial of foster care for institutional care , assessed from toddlerhood to 54 months .
Participants were 58 children with a history of institutional care and 31 never-institutionalized control (NIG) subjects enrolled in a randomized controlled trial of foster care for institutional care, assessed from toddlerhood to 54 months.
METHODS
Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure .
Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure.
RESULTS
In the Stranger at the Door procedure , children with a history of institutional care left with a stranger at higher rates than NIG subjects ( 33 % vs. 3.5 % ; P < .001 ) .
In the Stranger at the Door procedure, children with a history of institutional care left with a stranger at higher rates than NIG subjects (33 % vs. 3. 5 % ; P <. 001).
RESULTS
Children in the care as usual group left more than NIG subjects ( 41.9 % vs. 3.6 % ; P .001 ) .
Children in the care as usual group left more than NIG subjects (41. 9 % vs. 3. 6 % ; P. 001).
RESULTS
The differences between the foster care group ( 24.1 % ) and the care as usual group and between foster care group and NIG were not significant .
The differences between the foster care group (24. 1 %) and the care as usual group and between foster care group and NIG were not significant.
RESULTS
In a logistic regression , early disorganized attachment behaviors , baseline developmental quotient , and caregiving quality after randomization contributed to variance at 54 months .
In a logistic regression, early disorganized attachment behaviors, baseline developmental quotient, and caregiving quality after randomization contributed to variance at 54 months.
RESULTS
In the same analysis using only children with a history of institutional care , only disorganized attachment contributed significantly to 54-month indiscriminate social behaviors ( Exp [ B ] = 1.6 [ 95 % confidence interval : 1.1-2 .5 ] ) .
In the same analysis using only children with a history of institutional care, only disorganized attachment contributed significantly to 54-month indiscriminate social behaviors (Exp [B] = 1. 6 [95 % confidence interval : 1. 1-2. 5]).
CONCLUSIONS
Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care .
Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care.
CONCLUSIONS
Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors .
Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors.
OBJECTIVE
To compare the effect of delapril/manidipine vs olmesartan/hydrochlorothiazide ( HCTZ ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients .
To compare the effect of delapril/manidipine vs olmesartan/hydrochlorothiazide (HCTZ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients.
METHODS
After a 4-week placebo period , 88 obese , hypertensive ( DBP > 95 and < 110 mmHg ) outpatients were randomized to delapril 30 mg/manidipine 10 mg combination or to olmesartan 20 mg/HCTZ 12.5 mg combination for 24 weeks according to a prospective , randomized , open-label , blinded endpoint , parallel group design .
After a 4-week placebo period, 88 obese, hypertensive (DBP > 95 and < 110 mmHg) outpatients were randomized to delapril 30 mg/manidipine 10 mg combination or to olmesartan 20 mg/HCTZ 12. 5 mg combination for 24 weeks according to a prospective, randomized, open-label, blinded endpoint, parallel group design.
METHODS
At the end of the placebo period and treatment period , clinical BP , fasting plasma glucose ( FPG ) , plasma insulin , insulin sensitivity ( by euglycemic hyperinsulinemic clamp ) and plasma fibrinogen were evaluated .
At the end of the placebo period and treatment period, clinical BP, fasting plasma glucose (FPG), plasma insulin, insulin sensitivity (by euglycemic hyperinsulinemic clamp) and plasma fibrinogen were evaluated.
METHODS
Insulin sensitivity was expressed as the amount of glucose infused during the last 30 minutes ( glucose infusion rate , GIR ) in mg/Kg/min .
Insulin sensitivity was expressed as the amount of glucose infused during the last 30 minutes (glucose infusion rate, GIR) in mg/Kg/min.
METHODS
The total glucose requirement ( TGR ) to maintain a steady-state blood glucose level in response to a defined increase in plasma insulin concentration was also evaluated .
The total glucose requirement (TGR) to maintain a steady-state blood glucose level in response to a defined increase in plasma insulin concentration was also evaluated.
RESULTS
Both combinations significantly reduced SBP/DBP values ( -22.3 / 16.4 mmHg and -22.6 / 17.2 mmHg , respectively , all p < 0.001 vs placebo ) .
Both combinations significantly reduced SBP/DBP values (-22. 3 / 16. 4 mmHg and -22. 6 / 17. 2 mmHg, respectively, all p < 0. 001 vs placebo).
RESULTS
GIR was significantly increased only by delapril/manidipine ( +3.01 mg/min/Kg , p = 0.038 vs placebo ) , the difference between treatments being significant ( p < 0.05 ) .
GIR was significantly increased only by delapril/manidipine (+3. 01 mg/min/Kg, p = 0. 038 vs placebo), the difference between treatments being significant (p < 0. 05).
RESULTS
TGR was significantly increased by delapril/manidipine ( +9.7 g , p = 0.034 ) , while it was unaffected by olmesartan/HCTZ .
TGR was significantly increased by delapril/manidipine (+9. 7 g, p = 0. 034), while it was unaffected by olmesartan/HCTZ.
RESULTS
Plasma insulin as well as fibrinogen were significantly reduced by delapril/manidipine ( -17.8 pmol/l , p = 0.047 and -67.5 mg/dl , p = 0.021 , respectively ) , but not by olmesartan/HCTZ , the difference between the two treatments being statistically significant ( p < 0.05 ) .
Plasma insulin as well as fibrinogen were significantly reduced by delapril/manidipine (-17. 8 pmol/l, p = 0. 047 and -67. 5 mg/dl, p = 0. 021, respectively), but not by olmesartan/HCTZ, the difference between the two treatments being statistically significant (p < 0. 05).
CONCLUSIONS
In obese hypertensive patients the delapril/manidipine combination but not the olmesartan/HCTZ combination significantly decreased insulin resistance and plasma fibrinogen levels , despite the similar BP lowering efficacy .
In obese hypertensive patients the delapril/manidipine combination but not the olmesartan/HCTZ combination significantly decreased insulin resistance and plasma fibrinogen levels, despite the similar BP lowering efficacy.
OBJECTIVE
To test whether consumption of a beverage containing active ingredients will increase 24-hour energy metabolism in healthy , young , lean individuals .
To test whether consumption of a beverage containing active ingredients will increase 24-hour energy metabolism in healthy, young, lean individuals.
METHODS
Thirty-one male and female subjects consumed 3 x 250-mL servings of a beverage containing green tea catechins , caffeine , and calcium for 3 days in a single-center , double-blind , placebo-controlled , cross-over design study .
Thirty-one male and female subjects consumed 3 x 250-mL servings of a beverage containing green tea catechins, caffeine, and calcium for 3 days in a single-center, double-blind, placebo-controlled, cross-over design study.
METHODS
On the 3rd day , 23-hour energy metabolism , extrapolated to 24-hour , was measured in a calorimeter chamber .
On the 3rd day, 23-hour energy metabolism, extrapolated to 24-hour, was measured in a calorimeter chamber.
METHODS
Blood pressure and heart rate were measured , and total day and night urines were analyzed for urea and catecholamine excretion .
Blood pressure and heart rate were measured, and total day and night urines were analyzed for urea and catecholamine excretion.
RESULTS
Twenty-four-hour energy expenditure ( EE ) and 24-hour fat oxidation were lower in women than in men ( p < 0.0001 and p < 0.015 , respectively ) .
Twenty-four-hour energy expenditure (EE) and 24-hour fat oxidation were lower in women than in men (p < 0. 0001 and p < 0. 015, respectively).
RESULTS
Although there were no treatment or treatment/gender effects on substrate oxidation , treatment increased 24-hour EE by 106 + / - 31 kcal/24 hours ( p = 0.002 ) , equivalent to 4.7 + / - 1.6 kcal/h ( day ; p = 0.005 ) and 3.3 + / - 1.5 kcal/h ( night ; p = 0.04 ) .
Although there were no treatment or treatment/gender effects on substrate oxidation, treatment increased 24-hour EE by 106 + / - 31 kcal/24 hours (p = 0. 002), equivalent to 4. 7 + / - 1. 6 kcal/h (day ; p = 0. 005) and 3. 3 + / - 1. 5 kcal/h (night ; p = 0. 04).
RESULTS
No significant differences were observed in hemodynamic parameters .
No significant differences were observed in hemodynamic parameters.
CONCLUSIONS
The present study provides evidence that consumption of a beverage containing green tea catechins , caffeine , and calcium increases 24-hour EE by 4.6 % , but the contribution of the individual ingredients can not be distinguished .
The present study provides evidence that consumption of a beverage containing green tea catechins, caffeine, and calcium increases 24-hour EE by 4. 6 %, but the contribution of the individual ingredients can not be distinguished.
CONCLUSIONS
Although this increase is modest , the results are discussed in relation to proposed public health goals , indicating that such modifications are sufficient to prevent weight gain .
Although this increase is modest, the results are discussed in relation to proposed public health goals, indicating that such modifications are sufficient to prevent weight gain.
CONCLUSIONS
When consumed regularly as part of a healthy diet and exercise regime , such a beverage may provide benefits for weight control .
When consumed regularly as part of a healthy diet and exercise regime, such a beverage may provide benefits for weight control.
BACKGROUND
Dexlansoprazole MR , a modified-release formulation of dexlansoprazole , an enantiomer of lansoprazole , effectively heals erosive oesophagitis .
Dexlansoprazole MR, a modified-release formulation of dexlansoprazole, an enantiomer of lansoprazole, effectively heals erosive oesophagitis.
OBJECTIVE
To assess dexlansoprazole MR in maintaining healed erosive oesophagitis .
To assess dexlansoprazole MR in maintaining healed erosive oesophagitis.
METHODS
Patients ( n = 451 ) with erosive oesophagitis healed in either of two dexlansoprazole MR healing trials randomly received dexlansoprazole MR 60 or 90 mg or placebo once daily in this double-blind trial .
Patients (n = 451) with erosive oesophagitis healed in either of two dexlansoprazole MR healing trials randomly received dexlansoprazole MR 60 or 90 mg or placebo once daily in this double-blind trial.
METHODS
The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods .
The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods.
METHODS
Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries .
Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries.
RESULTS
Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing ( P < 0.0025 ) .
Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing (P < 0. 0025).
RESULTS
Maintenance rates were 87 % and 82 % for the 60 and 90 mg doses , respectively , vs. 26 % for placebo ( life table ) , and 66 % and 65 % vs. 14 % , respectively ( crude rate ) .
Maintenance rates were 87 % and 82 % for the 60 and 90 mg doses, respectively, vs. 26 % for placebo (life table), and 66 % and 65 % vs. 14 %, respectively (crude rate).
RESULTS
Both doses were superior to placebo for the percentage of 24-h heartburn-free days ( 60 mg , 96 % ; 90 mg , 94 % ; placebo , 19 % ) and nights ( 98 % , 97 % , and 50 % , respectively ) .
Both doses were superior to placebo for the percentage of 24-h heartburn-free days (60 mg, 96 % ; 90 mg, 94 % ; placebo, 19 %) and nights (98 %, 97 %, and 50 %, respectively).
RESULTS
Diarrhoea , flatulence , gastritis ( symptoms ) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo , but were not dose-related .
Diarrhoea, flatulence, gastritis (symptoms) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo, but were not dose-related.
CONCLUSIONS
Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo , and was well tolerated .
Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo, and was well tolerated.
BACKGROUND
The pathophysiology of anemia in coastal East Africa is complex .
The pathophysiology of anemia in coastal East Africa is complex.
BACKGROUND
Impaired erythropoietin production is one possible mechanism .
Impaired erythropoietin production is one possible mechanism.
BACKGROUND
Plasmodium falciparum malaria has been found to blunt erythropoietin production , whereas vitamin A stimulates erythropoietin production in vitro .
Plasmodium falciparum malaria has been found to blunt erythropoietin production, whereas vitamin A stimulates erythropoietin production in vitro.
OBJECTIVE
We investigated the 72-h effects of vitamin A and the antimalarial drug sulfadoxine pyramethamine ( SP ) on erythropoietin production in severely anemic ( hemoglobin < or = 70 g/L ) preschool children in Zanzibar , a region of known vitamin A deficiency .
We investigated the 72-h effects of vitamin A and the antimalarial drug sulfadoxine pyramethamine (SP) on erythropoietin production in severely anemic (hemoglobin < or = 70 g/L) preschool children in Zanzibar, a region of known vitamin A deficiency.
OBJECTIVE
We hypothesized that both treatments would stimulate erythropoietin production directly , within 72 h , before a change in hemoglobin would occur .
We hypothesized that both treatments would stimulate erythropoietin production directly, within 72 h, before a change in hemoglobin would occur.
METHODS
One hundred forty-one severely anemic children were identified during the baseline assessment of a morbidity substudy of a community-based micronutrient supplementation trial .
One hundred forty-one severely anemic children were identified during the baseline assessment of a morbidity substudy of a community-based micronutrient supplementation trial.
METHODS
All severely anemic children were randomly assigned to receive either vitamin A ( 100,000 or 200,000 IU depending on age ) or SP at baseline ; 72 h later they received the opposite treatment plus daily hematinic syrup for 90 d. Erythropoietic and parasitic indicators were assessed at baseline and again after 72 h.
All severely anemic children were randomly assigned to receive either vitamin A (100, 000 or 200, 000 IU depending on age) or SP at baseline ; 72 h later they received the opposite treatment plus daily hematinic syrup for 90 d. Erythropoietic and parasitic indicators were assessed at baseline and again after 72 h.