pietrolesci/pubmed-200k-rct · Datasets at Hugging Face

labels class label 5 classes	text stringlengths 3 1.81k	uid int64 0 2.21M
2METHODS	Adverse events were recorded .	2,211,200
4RESULTS	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 .	2,211,201
4RESULTS	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 % ) .	2,211,202
4RESULTS	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 ) .	2,211,203
1CONCLUSIONS	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 .	2,211,204
0BACKGROUND	Information regarding prognostic factors and survival in elderly women with metastatic breast cancer treated with tamoxifen is limited .	2,211,205
2METHODS	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 .	2,211,206
2METHODS	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 .	2,211,207
4RESULTS	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 ) .	2,211,208
4RESULTS	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 .	2,211,209
4RESULTS	In multivariate analysis , age at diagnosis approached statistical significance ( P = 0.055 ) for TTP but was not significant for OS ( P = 0.17 ) .	2,211,210
4RESULTS	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 .	2,211,211
4RESULTS	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 .	2,211,212
1CONCLUSIONS	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 .	2,211,213
1CONCLUSIONS	In elderly patients , DFI , PS , positive ER or PGR , and dominant disease site are independent prognostic factors .	2,211,214
3OBJECTIVE	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 .	2,211,215
2METHODS	Part 1 used a prospective , cross-over design .	2,211,216
2METHODS	Part 2 consisted of a prospective concurrent collection of polysomnographic data .	2,211,217
2METHODS	Sleep Disorders Center in a university medical center .	2,211,218
2METHODS	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 .	2,211,219
4RESULTS	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 .	2,211,220
4RESULTS	In part 1,77 DHSS home recordings were evaluated .	2,211,221
4RESULTS	No recordings were lost due to equipment failure and each parameter was scorable in greater than 95 % of all epochs .	2,211,222
4RESULTS	Most of the subjective assessments by questionnaire following each study revealed no difference between the two testing situations .	2,211,223
4RESULTS	However , patients reported more sleep time and a better overall test experience in the lab .	2,211,224
4RESULTS	Assessments of sleep quality and morning alertness compared to usual were rated higher in the lab .	2,211,225
4RESULTS	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 .	2,211,226
4RESULTS	There was no difference in the assessment of which test most accurately represented their sleep .	2,211,227
4RESULTS	In Part 2 , the DHSS recorded concurrently with paper PSG in the laboratory in 16 patients .	2,211,228
4RESULTS	The results show no significant differences for any parameter and strong positive correlations for all parameters .	2,211,229
1CONCLUSIONS	Using the DHSS , unattended full PSG can be performed in the home with reliable and high quality recordings .	2,211,230
1CONCLUSIONS	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 .	2,211,231
0BACKGROUND	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 .	2,211,232
2METHODS	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 ) .	2,211,233
2METHODS	The plasma concentrations of ilaprazole and its metabolites were monitored by LC-MS/MS method .	2,211,234
4RESULTS	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 ) .	2,211,235
4RESULTS	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 .	2,211,236
4RESULTS	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 ) .	2,211,237
1CONCLUSIONS	There was no demonstrated relationship between ilaprazole metabolism and CYP3A5 polymorphisms .	2,211,238
3OBJECTIVE	Gd-DTPA is a well-characterized , safe contrast agent frequently used in magnetic resonance imaging ( MRI ) of the central nervous system .	2,211,239
3OBJECTIVE	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 ) .	2,211,240
2METHODS	T1-weighted MRI was performed before contrast and after the administration of Gd-DOTA or Gd-DTPA ( 0.1 mmol/kg ) .	2,211,241
2METHODS	The MR images were scored for image quality , and the diagnostic efficacy also was assessed .	2,211,242
2METHODS	Patients were questioned 1 hour after injection , and adverse reactions were recorded .	2,211,243
4RESULTS	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 ) .	2,211,244
4RESULTS	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 ) .	2,211,245
4RESULTS	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 .	2,211,246
4RESULTS	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 ) .	2,211,247
4RESULTS	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 .	2,211,248
4RESULTS	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 ) .	2,211,249
1CONCLUSIONS	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 .	2,211,250
1CONCLUSIONS	Gd-DOTA is as safe a contrast agent as Gd-DTPA and has similar diagnostic efficacy .	2,211,251
3OBJECTIVE	This study included 54-month-old children with a history of institutional care .	2,211,252
3OBJECTIVE	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 .	2,211,253
2METHODS	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 .	2,211,254
2METHODS	Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure .	2,211,255
4RESULTS	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 ) .	2,211,256
4RESULTS	Children in the care as usual group left more than NIG subjects ( 41.9 % vs. 3.6 % ; P .001 ) .	2,211,257
4RESULTS	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 .	2,211,258
4RESULTS	In a logistic regression , early disorganized attachment behaviors , baseline developmental quotient , and caregiving quality after randomization contributed to variance at 54 months .	2,211,259
4RESULTS	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 ] ) .	2,211,260
1CONCLUSIONS	Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care .	2,211,261
1CONCLUSIONS	Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors .	2,211,262
3OBJECTIVE	To compare the effect of delapril/manidipine vs olmesartan/hydrochlorothiazide ( HCTZ ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients .	2,211,263
2METHODS	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 .	2,211,264
2METHODS	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 .	2,211,265
2METHODS	Insulin sensitivity was expressed as the amount of glucose infused during the last 30 minutes ( glucose infusion rate , GIR ) in mg/Kg/min .	2,211,266
2METHODS	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 .	2,211,267
4RESULTS	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 ) .	2,211,268
4RESULTS	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 ) .	2,211,269
4RESULTS	TGR was significantly increased by delapril/manidipine ( +9.7 g , p = 0.034 ) , while it was unaffected by olmesartan/HCTZ .	2,211,270
4RESULTS	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 ) .	2,211,271
1CONCLUSIONS	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 .	2,211,272
3OBJECTIVE	To test whether consumption of a beverage containing active ingredients will increase 24-hour energy metabolism in healthy , young , lean individuals .	2,211,273
2METHODS	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 .	2,211,274
2METHODS	On the 3rd day , 23-hour energy metabolism , extrapolated to 24-hour , was measured in a calorimeter chamber .	2,211,275
2METHODS	Blood pressure and heart rate were measured , and total day and night urines were analyzed for urea and catecholamine excretion .	2,211,276
4RESULTS	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 ) .	2,211,277
4RESULTS	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 ) .	2,211,278
4RESULTS	No significant differences were observed in hemodynamic parameters .	2,211,279
1CONCLUSIONS	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 .	2,211,280
1CONCLUSIONS	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 .	2,211,281
1CONCLUSIONS	When consumed regularly as part of a healthy diet and exercise regime , such a beverage may provide benefits for weight control .	2,211,282
0BACKGROUND	Dexlansoprazole MR , a modified-release formulation of dexlansoprazole , an enantiomer of lansoprazole , effectively heals erosive oesophagitis .	2,211,283
3OBJECTIVE	To assess dexlansoprazole MR in maintaining healed erosive oesophagitis .	2,211,284
2METHODS	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 .	2,211,285
2METHODS	The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods .	2,211,286
2METHODS	Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries .	2,211,287
4RESULTS	Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing ( P < 0.0025 ) .	2,211,288
4RESULTS	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 ) .	2,211,289
4RESULTS	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 ) .	2,211,290
4RESULTS	Diarrhoea , flatulence , gastritis ( symptoms ) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo , but were not dose-related .	2,211,291
1CONCLUSIONS	Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo , and was well tolerated .	2,211,292
0BACKGROUND	The pathophysiology of anemia in coastal East Africa is complex .	2,211,293
0BACKGROUND	Impaired erythropoietin production is one possible mechanism .	2,211,294
0BACKGROUND	Plasmodium falciparum malaria has been found to blunt erythropoietin production , whereas vitamin A stimulates erythropoietin production in vitro .	2,211,295
3OBJECTIVE	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 .	2,211,296
3OBJECTIVE	We hypothesized that both treatments would stimulate erythropoietin production directly , within 72 h , before a change in hemoglobin would occur .	2,211,297
2METHODS	One hundred forty-one severely anemic children were identified during the baseline assessment of a morbidity substudy of a community-based micronutrient supplementation trial .	2,211,298
2METHODS	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.	2,211,299

2METHODS

Adverse events were recorded .

2,211,200

4RESULTS

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 .

2,211,201

4RESULTS

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 % ) .

2,211,202

4RESULTS

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 ) .

2,211,203

1CONCLUSIONS

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 .

2,211,204

0BACKGROUND

Information regarding prognostic factors and survival in elderly women with metastatic breast cancer treated with tamoxifen is limited .

2,211,205

2METHODS

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 .

2,211,206

2METHODS

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 .

2,211,207

4RESULTS

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 ) .

2,211,208

4RESULTS

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 .

2,211,209

4RESULTS

In multivariate analysis , age at diagnosis approached statistical significance ( P = 0.055 ) for TTP but was not significant for OS ( P = 0.17 ) .

2,211,210

4RESULTS

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 .

2,211,211

4RESULTS

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 .

2,211,212

1CONCLUSIONS

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 .

2,211,213

1CONCLUSIONS

In elderly patients , DFI , PS , positive ER or PGR , and dominant disease site are independent prognostic factors .

2,211,214

3OBJECTIVE

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 .

2,211,215

2METHODS

Part 1 used a prospective , cross-over design .

2,211,216

2METHODS

Part 2 consisted of a prospective concurrent collection of polysomnographic data .

2,211,217

2METHODS

Sleep Disorders Center in a university medical center .

2,211,218

2METHODS

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 .

2,211,219

4RESULTS

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 .

2,211,220

4RESULTS

In part 1,77 DHSS home recordings were evaluated .

2,211,221

4RESULTS

No recordings were lost due to equipment failure and each parameter was scorable in greater than 95 % of all epochs .

2,211,222

4RESULTS

Most of the subjective assessments by questionnaire following each study revealed no difference between the two testing situations .

2,211,223

4RESULTS

However , patients reported more sleep time and a better overall test experience in the lab .

2,211,224

4RESULTS

Assessments of sleep quality and morning alertness compared to usual were rated higher in the lab .

2,211,225

4RESULTS

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 .

2,211,226

4RESULTS

There was no difference in the assessment of which test most accurately represented their sleep .

2,211,227

4RESULTS

In Part 2 , the DHSS recorded concurrently with paper PSG in the laboratory in 16 patients .

2,211,228

4RESULTS

The results show no significant differences for any parameter and strong positive correlations for all parameters .

2,211,229

1CONCLUSIONS

Using the DHSS , unattended full PSG can be performed in the home with reliable and high quality recordings .

2,211,230

1CONCLUSIONS

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 .

2,211,231

0BACKGROUND

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 .

2,211,232

2METHODS

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 ) .

2,211,233

2METHODS

The plasma concentrations of ilaprazole and its metabolites were monitored by LC-MS/MS method .

2,211,234

4RESULTS

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 ) .

2,211,235

4RESULTS

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 .

2,211,236

4RESULTS

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 ) .

2,211,237

1CONCLUSIONS

There was no demonstrated relationship between ilaprazole metabolism and CYP3A5 polymorphisms .

2,211,238

3OBJECTIVE

Gd-DTPA is a well-characterized , safe contrast agent frequently used in magnetic resonance imaging ( MRI ) of the central nervous system .

2,211,239

3OBJECTIVE

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 ) .

2,211,240

2METHODS

T1-weighted MRI was performed before contrast and after the administration of Gd-DOTA or Gd-DTPA ( 0.1 mmol/kg ) .

2,211,241

2METHODS

The MR images were scored for image quality , and the diagnostic efficacy also was assessed .

2,211,242

2METHODS

Patients were questioned 1 hour after injection , and adverse reactions were recorded .

2,211,243

4RESULTS

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 ) .

2,211,244

4RESULTS

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 ) .

2,211,245

4RESULTS

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 .

2,211,246

4RESULTS

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 ) .

2,211,247

4RESULTS

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 .

2,211,248

4RESULTS

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 ) .

2,211,249

1CONCLUSIONS

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 .

2,211,250

1CONCLUSIONS

Gd-DOTA is as safe a contrast agent as Gd-DTPA and has similar diagnostic efficacy .

2,211,251

3OBJECTIVE

This study included 54-month-old children with a history of institutional care .

2,211,252

3OBJECTIVE

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 .

2,211,253

2METHODS

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 .

2,211,254

2METHODS

Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure .

2,211,255

4RESULTS

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 ) .

2,211,256

4RESULTS

Children in the care as usual group left more than NIG subjects ( 41.9 % vs. 3.6 % ; P .001 ) .

2,211,257

4RESULTS

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 .

2,211,258

4RESULTS

In a logistic regression , early disorganized attachment behaviors , baseline developmental quotient , and caregiving quality after randomization contributed to variance at 54 months .

2,211,259

4RESULTS

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 ] ) .

2,211,260

1CONCLUSIONS

Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care .

2,211,261

1CONCLUSIONS

Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors .

2,211,262

3OBJECTIVE

To compare the effect of delapril/manidipine vs olmesartan/hydrochlorothiazide ( HCTZ ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients .

2,211,263

2METHODS

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 .

2,211,264

2METHODS

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 .

2,211,265

2METHODS

Insulin sensitivity was expressed as the amount of glucose infused during the last 30 minutes ( glucose infusion rate , GIR ) in mg/Kg/min .

2,211,266

2METHODS

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 .

2,211,267

4RESULTS

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 ) .

2,211,268

4RESULTS

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 ) .

2,211,269

4RESULTS

TGR was significantly increased by delapril/manidipine ( +9.7 g , p = 0.034 ) , while it was unaffected by olmesartan/HCTZ .

2,211,270

4RESULTS

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 ) .

2,211,271

1CONCLUSIONS

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 .

2,211,272

3OBJECTIVE

To test whether consumption of a beverage containing active ingredients will increase 24-hour energy metabolism in healthy , young , lean individuals .

2,211,273

2METHODS

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 .

2,211,274

2METHODS

On the 3rd day , 23-hour energy metabolism , extrapolated to 24-hour , was measured in a calorimeter chamber .

2,211,275

2METHODS

Blood pressure and heart rate were measured , and total day and night urines were analyzed for urea and catecholamine excretion .

2,211,276

4RESULTS

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 ) .

2,211,277

4RESULTS

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 ) .

2,211,278

4RESULTS

No significant differences were observed in hemodynamic parameters .

2,211,279

1CONCLUSIONS

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 .

2,211,280

1CONCLUSIONS

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 .

2,211,281

1CONCLUSIONS

When consumed regularly as part of a healthy diet and exercise regime , such a beverage may provide benefits for weight control .

2,211,282

0BACKGROUND

Dexlansoprazole MR , a modified-release formulation of dexlansoprazole , an enantiomer of lansoprazole , effectively heals erosive oesophagitis .

2,211,283

3OBJECTIVE

To assess dexlansoprazole MR in maintaining healed erosive oesophagitis .

2,211,284

2METHODS

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 .

2,211,285

2METHODS

The percentage of patients who maintained healing at month 6 was analysed using life table and crude rate methods .

2,211,286

2METHODS

Secondary endpoints were percentages of nights and of 24-h days without heartburn based on daily diaries .

2,211,287

4RESULTS

Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing ( P < 0.0025 ) .

2,211,288

4RESULTS

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 ) .

2,211,289

4RESULTS

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 ) .

2,211,290

4RESULTS

Diarrhoea , flatulence , gastritis ( symptoms ) and abdominal pain occurred more frequently with dexlansoprazole MR than placebo , but were not dose-related .

2,211,291

1CONCLUSIONS

Dexlansoprazole MR effectively maintained healed erosive oesophagitis and symptom relief compared with placebo , and was well tolerated .

2,211,292

0BACKGROUND

The pathophysiology of anemia in coastal East Africa is complex .

2,211,293

0BACKGROUND

Impaired erythropoietin production is one possible mechanism .

2,211,294

0BACKGROUND

Plasmodium falciparum malaria has been found to blunt erythropoietin production , whereas vitamin A stimulates erythropoietin production in vitro .

2,211,295

3OBJECTIVE

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 .

2,211,296

3OBJECTIVE

We hypothesized that both treatments would stimulate erythropoietin production directly , within 72 h , before a change in hemoglobin would occur .

2,211,297

2METHODS

One hundred forty-one severely anemic children were identified during the baseline assessment of a morbidity substudy of a community-based micronutrient supplementation trial .

2,211,298

2METHODS

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.

2,211,299